AU2025217270A1 - Method of titrating dose of psychedelics - Google Patents
Method of titrating dose of psychedelicsInfo
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- AU2025217270A1 AU2025217270A1 AU2025217270A AU2025217270A AU2025217270A1 AU 2025217270 A1 AU2025217270 A1 AU 2025217270A1 AU 2025217270 A AU2025217270 A AU 2025217270A AU 2025217270 A AU2025217270 A AU 2025217270A AU 2025217270 A1 AU2025217270 A1 AU 2025217270A1
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/48—Ergoline derivatives, e.g. lysergic acid, ergotamine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/66—Phosphorus compounds
- A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
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Abstract
#$%^&*AU2025217270A120250828.pdf#####
1006092723
METHOD OF TITRATING DOSE OF PSYCHEDELICS
ABSTRACT
A method of dosing a psychedelic that avoids the side effects of hallucinations and
perceptual disturbances by administering the psychedelic to an individual in a titrating dosing
regimen and reducing side effects of hallucinations and perceptual disturbances. A kit for
administering a titrating dosing regimen of a psychedelic, including a pharmaceutically
effective amount of the psychedelic in dosage forms separated in packaging according to dose
and time of administration in a titrating dosing regimen, and instructions for use. A method of
treating an individual with psychedelics, by administering the psychedelic to the individual
having a condition or disease in a titrating dosing regimen and reducing side effects of
hallucinations and perceptual disturbances during treatment.
1006092723
METHOD OF TITRATING DOSE OF PSYCHEDELICS
ABSTRACT
A method of dosing a psychedelic that avoids the side effects of hallucinations and
perceptual disturbances by administering the psychedelic to an individual in a titrating dosing
regimen and reducing side effects of hallucinations and perceptual disturbances. A kit for
administering a titrating dosing regimen of a psychedelic, including a pharmaceutically
effective amount of the psychedelic in dosage forms separated in packaging according to dose
and time of administration in a titrating dosing regimen, and instructions for use. A method of
treating an individual with psychedelics, by administering the psychedelic to the individual
having a condition or disease in a titrating dosing regimen and reducing side effects of
hallucinations and perceptual disturbances during treatment.
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Description
1006092723 1006092723
METHOD OF TITRATING TITRATINGDOSE DOSEOFOF PSYCHEDELICS 12 Aug 2025
[0001]
[0001] This application This application isisa divisional a divisional application application of Australian of Australian application application no. no. 2022268891, 2022268891, the the entire entire disclosure disclosure of which of which is incorporated is incorporated herein herein by reference. by reference.
1. 1. TECHNICAL FIELD TECHNICAL FIELD
[0002] Thepresent
[0002] The presentinvention invention relates relates to to compositions compositions and methodsfor and methods for dosing dosingpsychedelics. psychedelics. 2025217270
2. BACKGROUND 2. BACKGROUND ART ART
[0003]
[0003] Psychedelics including lysergic Psychedelics including lysergic acid acid diethylamide diethylamide (LSD) are substances (LSD) are substancescapable capable of inducing of unique inducing unique subjective subjective effects effects including including alterations alterations of consciousness, of consciousness, positive positive emotions, emotions,
enhanced introspection, changes enhanced introspection, changesininthe theperception perceptionofofthe theenvironment, environment,the thebody, body,and and theself the self as well asassynesthesia, as well synesthesia, mystical-type mystical-type experiences, experiences, and experiences and experiences of ego dissolution of ego dissolution
(Carhart-Harris (Carhart-Harris etetal., al.,2016b; 2016b; Dolder Dolder et al., et al., 2016; 2016; HolzeHolze et 2021; et al., al., 2021; Liechti, Liechti, 2017; et 2017; Passie Passie et al., 2008; al., 2008; Schmid Schmid etet al.,2015). al., 2015).
[0004]
[0004] All serotonergic All serotonergic psychedelics psychedelics including includingLSD, LSD, psilocybin, psilocybin,DMT, DMT, and mescalineare and mescaline are nonspecific serotonin nonspecific serotonin agonists agonistsincluding includingagonist agonistactivity activity at at the the serotonin serotonin5-HT2A 5-HT2A receptor receptor
(Rickli (Rickli et al., 2016) et al., and 2016) and maymay therefore therefore produce produce overall similar overall largely largelyeffects. similar Additionally, effects. Additionally, psychedelic substances psychedelic substances produce produce their their acute acute effectseffects in humans in humans via activation via activation of the serotonin of the serotonin 5- 5- HT2A receptor HT2A receptor as specifically as specifically shown shown in clinical in clinical studies studies for LSDfor LSDet(Holze (Holze et al., al., 2021; 2021;etPreller et Preller
al., al.,2017). 2017). LSD andother LSD and other hallucinogens hallucinogensare arepartial partial agonists agonists of of the theserotonin serotonin5-HT2A receptor 5-HT2A receptor
(López-Giménez, (López-Giménez, et et al.al.Hallucinogens Hallucinogens andand Serotonin Serotonin 5-HT2A 5-HT2A Receptor-Mediated Receptor-Mediated Signaling Signaling
Pathways. CurrTop Pathways. Curr TopBehav Behav Neurosci. Neurosci. 2018;36:45-73; 2018;36:45-73; CanalCanal CE. Serotonergic CE. Serotonergic Psychedelics: Psychedelics:
Experimental Experimental Approaches for Assessing Approaches for Assessing Mechanisms Mechanismsof of Action. Action. Handb Handb ExpExp Pharmacol. Pharmacol. 2018;252:227-260). 2018;252:227-260).
[0005]
[0005] Acute effects Acute effects of of psychedelics psychedelicsthat that may maycontribute contributetototheir theirtherapeutic therapeuticbenefits benefits include enhancingthethe include enhancing therapeutic therapeutic relationship relationship by by increased increased openness, openness, trust, trust, feelings feelings of of connectedness connectedness ororemulsion emulsion with with people, people, insightininpsychological insight psychologicalproblems problemsandand stimulation stimulation of of
neuroregenerative processes neuroregenerative processes as described as described in detail in detail elsewhere elsewhere (Vollenweider (Vollenweider & Preller, &2020). Preller, 2020).
[0006]
[0006] Psychedelic administration, Psychedelic administration, especially especially at doses at doses believed believed to be to be therapeutic, therapeutic, has a has a
side side effect effect of ofhallucinations hallucinationsoror perceptual disturbances perceptual disturbances(Ungerleider, J. J. (Ungerleider, THOMAS. "Theacute THOMAS. "The acute side effects from side effects from LSD." LSD." The problems and The problems andprospects prospectsof ofLSDLSD (1968):61-68), (1968): 61-68),(Nichols, (Nichols, Psychedelics, PharmacolRev Psychedelics, Pharmacol Rev 68:264-355). 68:264-355). These These sideside effects effects makemake it unsafe it unsafe for for subjects subjects to to
1
1006092723 1006092723
administer administer psychedelics psychedelics except except under direct medical supervision and could present present aa 12 Aug 2025
under direct medical supervision and could significant risk to significant risk to patient safetyifif the patient safety the side sideeffects effectsoccur occur while while thethe patient patient is driving, is driving, operating operating
machinery machinery orornot notunder under medical medical supervision. supervision. These These side side effects effects that that are hallmarks are the the hallmarks of of psychedelic administration are psychedelic administration aremediated mediated by drug's by the the drug’s activity activity at serotonin at the the serotonin 5-HT2A5-HT2A
receptor, asevidenced receptor, as evidenced by the by the factfact thatthat blockade blockade of activity of this this activity (by administration (by administration of a 5-HT2A of a 5-HT2A
antagonist, such antagonist, such as as ketanserin) ketanserin) can can attenuate attenuate these these psychoactive psychoactive / hallucinogenic / hallucinogenic side effects side effects
(Holze et al., (Holze et al., 2020). 2020). 2025217270
[0007]
[0007] Repeat administration Repeat administration of of psychedelics psychedelics (e.g., (e.g., on a on a daily daily basis) basis) hasshown has been beentoshown to qualitatively qualitatively have clinical benefit have clinical benefitwhile whilethe theside side effects effects of of hallucination/perceptual hallucination/perceptual disturbance disturbance
may may gogo away away after after a few a few days days of treatment of treatment due to due to tachyphylaxis tachyphylaxis (i.e., (i.e., via downvia down regulation regulation of 5- of 5- HT2A receptors) as HT2A receptors) as reviewed reviewed by byBuchborn Buchborn(2016). (2016). Nonetheless, for the Nonetheless, for thefirst first days daysofof administration administration of of aa psychedelic psychedelic drug, drug, the the subject subject is islikely to to likely experience the experience common the adverse common adverse
events of hallucination, events of hallucination, perceptual disturbance and perceptual disturbance andothers othersthat thatmaymay present present a risk a risk to the to the
patient. patient.
[0008]
[0008] TheCleveland The Cleveland Clinic Clinic describes describes that that titration titration is aismethod a method that limits that limits potential potential side side effects by taking effects by takingtime timetotosee see how how one’s one's body body reactsreacts to a wherein to a drug, drug, wherein medication medication is startedisatstarted at
a low dose a low doseand andthen then the the dose dose is is raised raised every every couple couple of weeks of weeks untiluntil the the maximum maximum effective effective
dose(target dose (targetdose) dose) has has been been achieved achieved or effects or side side effects occur.occur. Caffrey, Caffrey, et al.Adv et al. (Ther (Ther DrugAdv Saf.Drug Saf. 2021 Jan19; 2021 Jan 19; 11: 11: 2042098620958910) 2042098620958910) describes describes that that titrationisiscommonly titration commonly used used forfor drugs drugs with with
a narrow therapeutic a narrow therapeutic index index to to provide provide treatment treatment at at the the lowest lowest dose dosepossible possiblewhile while minimizing minimizing medication useand medication use andside sideeffects. effects.ItItisis aa patient-centered patient-centered approach approachtotoprovide provideindividualized individualized therapy. Titration therapy. Titration has beenusedused has been for antibiotics, for antibiotics, anticoagulants, anticoagulants, anticonvulsants, anticonvulsants, antidepressants, antidiabetics, antidepressants, antidiabetics, antipsychotics, antipsychotics, opioids, opioids, and and stimulants. stimulants.
[0009]
[0009] There remains There remainsa a need need for for treatments treatments withwith psychedelics psychedelics that that avoidavoid or reduce or reduce
unwanted side unwanted side effects. effects.
[00010]
[00010] The present The presentinvention invention provides provides for for aa method of dosing method of dosingaapsychedelic psychedelicthat that avoids avoids the side the side effects effectsof of hallucinations hallucinationsand and perceptual perceptual disturbances disturbances by administering by administering the psychedelic the psychedelic
to an to anindividual individualinina atitrating titratingdosing dosing regimen regimen and reducing and reducing side of side effects effects of hallucinations hallucinations and and perceptual disturbances. perceptual disturbances.
[00011]
[00011] The present The presentinvention inventionprovides provides forfor a kit a kit forfor administering administering a titrating a titrating dosing dosing
regimen of aa psychedelic, regimen of psychedelic, including including a a pharmaceutically effective amount pharmaceutically effective of the amount of the psychedelic psychedelic in in
2
1006092723 1006092723
dosage formsseparated separated in packaging according to and dose and of time of administration in a 12 Aug 2025
dosage forms in packaging according to dose time administration in a
titrating dosing titrating dosing regimen, and regimen, and instructions instructions forfor use. use.
[00012]
[00012] The present The presentinvention inventionalso alsoprovides providesfor for aamethod methodof of treatingananindividual treating individualwith with psychedelics, psychedelics, byby administering administering the psychedelic the psychedelic to the to the individual individual having having a condition a condition or diseaseor disease
in a titrating in a titrating dosing regimenand dosing regimen and reducing reducing sideside effects effects of hallucinations of hallucinations and and perceptual perceptual
disturbancesduring disturbances during treatment. treatment.
DESCRIPTION DESCRIPTION OF OF THE THE DRAWINGS DRAWINGS 2025217270
[00013]
[00013] Other advantagesofofthe Other advantages the present present invention invention are are readily readilyappreciated appreciated as as the thesame same
becomes betterunderstood becomes better understoodbybyreference referencetotothe thefollowing following detailed detailed description descriptionwhen when considered considered
in in connection connection with with the theaccompanying drawingswherein: accompanying drawings wherein:
[00014]
[00014] FIGURE FIGURE 1 1 isisaagraph graphofofdose doseversus versustime. time. DETAILED DESCRIPTION DETAILED DESCRIPTION OFOF THE THE INVENTION INVENTION
[00015]
[00015] The present The presentinvention invention provides provides for for aa method of dosing method of dosingaapsychedelic psychedelicthat that avoids avoids the side the side effects effectsof of hallucinations hallucinationsand and perceptual perceptual disturbances disturbances by administering by administering the psychedelic the psychedelic
to an to an individual individual in in aa titrating titrating dosing regimenand dosing regimen andreducing reducing side side effects effects of hallucinations, of hallucinations,
perceptual disturbances, and perceptual disturbances, andother otherimmediately immediately detectable detectable effects effects of of thethe psychedelic psychedelic while while
preserving desired preserving desired therapeutic therapeutic benefits. benefits.
[00016]
[00016] More specifically,the More specifically, thetitrating titrating dosing regimen dosing regimen cancan include include administering administering a starting a starting
dose to dose to the the individual, individual, and at aa set and at set amount amountofoftime, time,increasing increasingthe thedose dose a set a set amount amount and and administering theincreased administering the increased dosedose toindividual, to the the individual, and repeating and repeating these these steps steps over overofa period of a period
time that time that the the individual individualisisbeing beingtreated treatedand and until untila amaximum desireddose maximum desired doseisisreached. reached.TheThe dosing regimencan dosing regimen cangenerally generallybe bedescribed describedbybythe thefollowing following equation: Dose= =XX(starting equation: Dose (starting dose) dose)
+ Y (dose + Y (doseincrease) increase)* Z* (period Z (period of of time) time)
[00017]
[00017] As opposed As opposedtotothe theprior prior uses usesofof repeat repeatdaily daily administration administration (of (of for forexample example 100 100
µg LSDevery µg LSD everyday), day),the thestarting starting dose can be dose can beaasub-perceptual sub-perceptualdose dose(e.g., (e.g., 10 10 µg) µg) and andtaper taperup up over time in over time in aa regimen that would regimen that would never neverhave havethe thehallucinatory hallucinatoryside sideeffect effect but but would would achieve achieve an effective dose an effective dosethat thatwould would be be perceptual/hallucinogenic perceptual/hallucinogenio if administered if administered in the absence in the absence of the of the titration regimen titration (e.g., 30, regimen (e.g., 30, 50, 50, 100 100oror200 200 µg µg as as the the target target therapeutic therapeutic dose). dose). For example, For example, the the starting starting dose canbebe dose can 10 10 µg, µg, which which is increased is increased by 10 by 10 µg(2, µg every every 3, 4,(2, 5, 3, 4, 75,days). 6 or 6 or 7Other days). Other starting starting doses doses can be within can be within the the ranges rangesdescribed describedbelow. below.Other Other examples examples of dosing of dosing can be can be
found in found in Buchborn (2016). Buchborn (2016).
[00018]
[00018] The time The timeperiod periodcan canbebe hours, hours, days, days, weeks, weeks, months, months, or years, or years, or intervals or intervals of of
3
1006092723 1006092723
dose titration titration with withintervals intervalsofof non-dosing, non-dosing,where where each dosetitration titration period period can lead to to the the 12 Aug 2025
dose each dose can lead
ability ability to toavoid avoid hallucinations, perceptual,and hallucinations, perceptual, and other other detectable detectable effects effects of the of the psychedelic, psychedelic, while while
preserving preserving ororenhancing enhancing desired desired therapeutic therapeutic effects. effects.
[00019]
[00019] The starting The starting dose andincreased dose and increaseddose doselevels levelscan canbebeadministered administered once once perper day, day,
twice per twice per day day or or three three times timesper perday, day,and andcancan be be administered administered by aby a care care giver, giver, healthcare healthcare
provider, or self provider, or self administered administered byby thethe patient patient with with or or without without supervision. supervision.
[00020]
[00020] The dose The doseincrease increasecan can be be anyany small small amount amount such such as20, as 10, 10,3020,or30 50 or 50and µg, µg, and 2025217270
can beeffected can be effectedandand determined determined byand by drug drug and formulation formulation variation, variation, andspecific and patient patientfactors specific factors such as weight, such as weight, height, height, body surface area, body surface area, biochemical assays,metabolic biochemical assays, metabolicassays, assays,ororgenomic genomic assays. assays.
[00021]
[00021] The dosage The dosageform formused used cancan be be any any suitable suitable dosage dosage formform suchsuch as tablets, as tablets, capsules, lozenges, capsules, lozenges, transdermal transdermal patches, patches, implanted implanted devices,devices, solutions, solutions, gels, emulsions, gels, emulsions, or any or any solid solid or or liquid liquid form, form, or or some combination some combination of forms, of forms, as well as well as those as those further further described described below. below.
[00022]
[00022] The starting The starting dose can also dose can also be be aa larger larger loading loading dose administeredunder dose administered undermedical medical supervision followed supervision followed by by repeat repeat sub-perceptual sub-perceptualdoses dosesto to maintain maintain thethe treatment treatment benefit benefit while while
limiting sideeffects limiting side effects to to only only the first the first dose.dose.
[00023]
[00023] Thepsychedelics The psychedelics in the in the present present invention invention can can be, butbe, arebut not are not limited limited to, lysergic to, lysergic
acid diethylamide (LSD), acid diethylamide (LSD),psilocybin, psilocybin, mescaline, mescaline,5-methoxy-N,N-dimethyltryptamine 5-methoxy-N,N-dimethyltryptamine (5-MeO- (5-MeO-
DMT), dimethyltryptamine(DMT), DMT), dimethyltryptamine (DMT), 2,5-dimethoxy-4-iodoamphetamine 2,5-dimethoxy-4-iodoamphetamine. (DOI), (DOI), 2,5-dimethoxy-4- 2,5-dimethoxy-4-
bromoamphetamie (DOB), bromoamphetamie (DOB), saltssalts thereof, thereof, tartrates tartrates thereof, thereof, analogs analogs thereof, thereof, or homologues or homologues
thereof. Preferably, thereof. Preferably, the the dose dose of of the the psychedelic psychedelicisis one onethat that provides providesaameaningful meaningfuleffect. effect.AA dose of dose of 0.01-1 0.01-1 mg mg(10-1000 (10-1000 µg)µg) cancan be used be used of LSD. of LSD. Psilocybin Psilocybin can can be be dosed dosed at 5-50atmg, 5-50 mg, mescaline mescaline can can be be dosed dosed at at 50-800 50-800 mg, mg, 5-MeO-DMT canbebedosed 5-MeO-DMT can dosedatat1-20 1-20 mg, mg, DMT DMT canbebe can dosed at 20-100 dosed at 20-100 mg, DOI can mg, DOI can be be dosed dosedat at 0.1-5 0.1-5 mg, mg, and DOBcan and DOB canbebedosed dosedatat0.1-5 0.1-5 mg. mg. Effects of the Effects of the psychedelic psychedelic drug drug can can lastlast 1-121-12 hourshours after after administration, administration, and theand the individual individual can can be supervised be supervised by by medical medical personnel personnel such such as as a psychiatrist a psychiatrist during during this this time. Iftime. lower If lower doses aredoses are
given, medical given, medical supervision supervision can can be be unnecessary. unnecessary.
[00024]
[00024] The present The presentinvention inventioncan can carry carry outout itsits clinicaleffect clinical effect by bydown-regulating down-regulating(or(or
reducing the expression reducing the expression of) of) the the serotonin serotonin 5-HT2A receptoror 5-HT2A receptor or by by another anothermechanism mechanismof of action action
that reduces that thehallucinogenic reduces the hallucinogenic effects effects of aofpsychedelic a psychedelic drug drug over over time. time.
[00025]
[00025] The compounds The compoundsof of thethe present present invention invention areare administered administered andand dosed dosed in in accordancewith accordance withgood good medical medical practice, practice, considering considering the the clinical clinical condition condition of of thethe individual individual
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patient, the site site and andmethod method of administration, scheduling of administration, patient sex,age, sex, 12 Aug 2025
patient, the of administration, scheduling of administration, patient age,
body weight and body weight andother otherfactors factors known knowntotomedical medicalpractitioners. practitioners. The Thepharmaceutically pharmaceutically"effective "effective amount"for amount" for purposes purposesherein hereinisisthus thusdetermined determinedby by such such considerations considerations as are as are known known in in the the art. Theamount art. The amount mustmust be effective be effective to achieve to achieve improvement improvement including including but not to but not limited limited to improved survival rate improved survival rate or or more more rapid rapid recovery, recovery, or orimprovement or elimination improvement or elimination of ofsymptoms and symptoms and
other indicatorsasasare other indicators areselected selectedas as appropriate appropriate measures measures byskilled by those those skilled in the art. in the art.
[00026]
[00026] In In the the method of the method of the present present invention, invention, the the compounds compounds of of thepresent the presentinvention invention 2025217270
can be administered can be administeredin in various various ways. ways. ItIt should should be be noted notedthat that they they can can be beadministered administeredasasthe the compound compound andand can can be administered be administered alone alone or active or as an as an ingredient active ingredient in combination in combination with with pharmaceutically acceptablecarriers, pharmaceutically acceptable carriers, diluents, diluents,adjuvants, adjuvants,and and vehicles. vehicles. The compounds The compounds cancan
be administered orally, be administered orally, transcutaneously, transcutaneously, subcutaneously subcutaneouslyor or parenterallyincluding parenterally including intravenous, intramuscular, intravenous, intramuscular, andand intranasal intranasal administration. administration. The patient The patient being treated being treated is a warm- is a warm-
blooded animaland, blooded animal and,inin particular, particular, mammals includingman. mammals including man.TheThe pharmaceutically pharmaceutically acceptable acceptable
carriers, diluents, adjuvants, carriers, diluents, adjuvants,andand vehicles vehicles as well as well as implant as implant carriers carriers generally generally refer to refer inert,to inert,
non-toxic solidororliquid non-toxic solid liquidfillers, fillers, diluents or encapsulating diluents or encapsulating material material not reacting not reacting withactive with the the active ingredients ofthe ingredients of theinvention. invention.
[00027]
[00027] The doses The dosescan can bebe single single doses doses or or multiple multiple doses doses orcontinuous or a a continuous dosedose over over a a period of several period of severalhours, hours,days, days, weeks, weeks, or months. or months.
[00028]
[00028] Whenadministering When administeringthethecompound compound of present of the the present invention invention parenterally, parenterally, it will it will
generallybebeformulated generally formulated in ainsublingual a sublingual or buccal or buccal dissolving dissolving tablet, tablet, dissolving dissolving film, intranasal film, intranasal
powder, intranasal solution, powder, intranasal solution, inhaled inhaled powder, powder, inhaled inhaled solution, solution, transdermal transdermal patch, patch, transdermal transdermal
patch (with microneedles patch (with or other microneedles or other permeation permeationenhancers) enhancers)or or asas a unitdosage a unit dosage injectableform injectable form (solution, (solution, suspension, emulsion). TheThe suspension, emulsion). pharmaceutical pharmaceutical formulations formulations suitable suitable for injection for injection
include sterile aqueous include sterile solutions or aqueous solutions or dispersions dispersionsand andsterile sterilepowders powdersforfor reconstitutioninto reconstitution into sterile sterile injectable injectable solutions or dispersions. solutions or dispersions.TheThe carrier carrier cana be can be a solvent solvent or dispersing or dispersing medium medium
containing, forexample, containing, for example, water, water, ethanol, ethanol, polyol polyol (for example, (for example, glycerol, glycerol, propylene propylene glycol, liquid glycol, liquid
polyethylene glycol,and polyethylene glycol, andthethe like),suitable like), suitablemixtures mixtures thereof, thereof, and and vegetable vegetable oils. oils.
[00029]
[00029] Proper fluidity can Proper fluidity canbe be maintained, maintained, for forexample, example, by by the the use of a use of coating such a coating such as as lecithin, lecithin, by by the maintenance the maintenance of the of the required required particle particle size size incase in the the of case of dispersion dispersion and by the and by the
use of surfactants. use of surfactants. Nonaqueous vehiclessuch Nonaqueous vehicles such a cottonseed a cottonseed oil,sesame oil, sesame oil,olive oil, olive oil, oil, soybean soybean
oil, oil, corn corn oil, oil,sunflower oil, or sunflower oil, or peanut oiland peanut oil andesters, esters, such such as isopropyl as isopropyl myristate, myristate, may may also be also be
used assolvent used as solventsystems systemsforforcompound compound compositions. compositions. Additionally, Additionally, various various additives additives whichwhich
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enhance thethe stability, sterility,andand isotonicity of compositions, the compositions, includingincluding antimicrobial 12 Aug 2025
enhance stability, sterility, isotonicity of the antimicrobial
preservatives, preservatives, antioxidants, antioxidants, chelating chelatingagents, agents, and and buffers, buffers, can can be added. Prevention be added. Prevention of of thethe
action action of of microorganisms canbebe microorganisms can ensured ensured by various by various antibacterial antibacterial andand antifungal antifungal agents, agents, forfor
example, parabens, example, parabens, chlorobutanol, chlorobutanol, phenol, phenol, sorbic sorbic acid, acid, and the and like.the In like. In many many cases, cases, it will be it will be
desirable to desirable to include include isotonic isotonic agents, agents, for for example, example,sugars, sugars, sodium sodium chloride, chloride, and like. and the the like. Prolonged absorptionof Prolonged absorption of the the injectable injectablepharmaceutical pharmaceutical form form can can be brought about be brought about by by the the use use of of agents delaying absorption, agents delaying absorption, for for example, example,aluminum aluminum monostearate monostearate and gelatin. and gelatin. According According to to 2025217270
the present the present invention, invention, however, however,anyany vehicle, vehicle, diluent,or or diluent, additive additive used used would would have have to be to be compatible with the compatible with the compounds. compounds.
[00030]
[00030] Sterile Sterile injectable injectablesolutions solutionscan can be preparedbybyincorporating be prepared incorporatingthethe compounds compounds
utilized utilized in in practicing thepresent practicing the present invention invention in the in the required required amountamount of the appropriate of the appropriate solvent solvent with various with variousofofthe theother otheringredients, ingredients,asas desired. desired.
[00031]
[00031] A pharmacological A pharmacologicalformulation formulationofofthe thepresent presentinvention inventioncan can be be administered administered to to the patient the patient in in an injectable formulation an injectable containing any formulation containing any compatible compatiblecarrier, carrier, such suchasasvarious various vehicle, adjuvants, vehicle, adjuvants,additives, additives, andand diluents; diluents; or the or the compounds compounds utilizedutilized in the present in the present inventioninvention
can beadministered can be administeredparenterally parenterallytotothethepatient patientin inthetheform form of of slow-release slow-release subcutaneous subcutaneous
implants or targeted implants or targeteddelivery deliverysystems systems such such as monoclonal as monoclonal antibodies, antibodies, vectored vectored delivery, delivery,
iontophoretic, polymer iontophoretic, polymer matrices, matrices, liposomes, liposomes, and microspheres.Examples and microspheres. Examples of delivery of delivery systems systems
useful in the useful in thepresent present invention invention include: include: 5,225,182; 5,225,182; 5,169,383; 5,169,383; 5,167,616; 5,167,616; 4,959,217; 4,959,217;
4,925,678; 4,487,603; 4,925,678; 4,487,603;4,486,194; 4,486,194;4,447,233; 4,447,233; 4,447,224; 4,447,224; 4,439,196; 4,439,196; and 4,475,196. and 4,475,196. Many Many other suchimplants, other such implants, delivery delivery systems, systems, and and modules modules are are well welltoknown known to thoseinskilled those skilled in the art. the art.
[00032]
[00032] The present The presentinvention inventionprovides provides forfor a kit a kit forfor administering administering a titrating a titrating dosing dosing
regimen of aa psychedelic, regimen of psychedelic, including including a a pharmaceutically effective amount pharmaceutically effective of the amount of the psychedelic psychedelic in in dosage formsseparated dosage forms separated in packaging in packaging according according to and to dose dose and time of time of administration administration in a in a titrating dosing titrating dosing regimen, and instructions regimen, and instructions for for use. use. The The startingdose starting dose andand eacheach additional additional
increased dose increased dose can can be inbe in different different colorscolors and/or and/or sizes sizes for for an individual an individual to easily to easily distinguish distinguish
them. The them. The increased increased dose dose can can be abe a single single dosage dosage form form or or multiple multiple separate separate dosagedosage forms forms (i.e., (i.e.,one onedosage dosage form (i.e., tablet, form (i.e., patch, tablet, etc.) patch, for for etc.) eacheach dose increase). dose The increase). Thepackaging packaging can can
indicate indicate which time period which time period each eachdose dose should should be taken be taken in, such in, such as inas in hours, hours, days,days, weeks,weeks,
months, oryears. months, or years.TheThe packaging packaging canin be can be in a bubble/blister a bubble/blister pack form, pack form, which allows which allows the the individual to pop individual to outthe pop out theexact exactdose dose needed needed for each for each administration. administration.
[00033]
[00033] The present The presentinvention inventionalso alsoprovides providesfor for aamethod methodof of treatingananindividual treating individualwith with
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psychedelics, psychedelics, byby administering the psychedelic to the to the individual having having a condition or diseaseor disease 12 Aug 2025
administering the psychedelic individual a condition
in a titrating in a titrating dosing regimenand dosing regimen and reducing reducing sideside effects effects of hallucinations of hallucinations and and perceptual perceptual
disturbancesduring disturbances during treatment. treatment.
[00034]
[00034] Thecondition The conditionorordisease disease being being treated treated with with the methods the methods of the present of the present inventioninvention
can include,but can include, butisisnot notlimited limitedto, to,anxiety anxietydisorders disorders (including (including anxiety anxiety in advanced in advanced stage illness stage illness
e.g. e.g. cancer, aswell cancer, as wellasasgeneralized generalized anxiety anxiety disorder), disorder), depression depression (including (including postpost partum partum
depression, major depression, major depressive depressivedisorder disorder and andtreatment-resistant treatment-resistant depression), depression), headache disorder headache disorder 2025217270
(including (including cluster clusterheadaches and migraine headaches and migraineheadache), headache),obsessive obsessive compulsive compulsive disorder disorder (OCD), (OCD),
personality disorders (including personality disorders (including conduct conductdisorder), disorder),stress stressdisorders disorders(including (includingadjustment adjustment disorders and disorders and post-traumatic post-traumatic stress stress disorder), disorder), drug disorders (including drug disorders (including alcohol alcohol dependence, dependence,
nicotine nicotine dependence, dependence, opioid opioid dependence, cocaine dependence, dependence, cocaine dependence, methamphetamine methamphetamine dependence), other dependence), other addictions addictions (including (including gambling gambling disorder, disorder, eatingeating disorder, disorder, and body and body
dysmorphicdisorder), dysmorphic disorder),pain, pain,neurodegenerative neurodegenerative disorders disorders (such(such as dementia, as dementia, Alzheimer’s Alzheimer's
Disease, Parkinson’sDisease), Disease, Parkinson's Disease), movement movement disorders disorders (such (such as as essential essential tremor, tardive tremor, tardive
dyskinesia), autism dyskinesia), spectrumdisorder, autism spectrum disorder,eating eatingdisorders, disorders,ororneurological neurologicaldisorders disorders(such (suchasas stroke or traumatic stroke or traumaticbrain braininjury). injury).
[00035]
[00035] The invention The inventionisisfurther furtherdescribed described in detail in detail by reference by reference to thetofollowing the following experimental examples. experimental examples.These These examples examples are provided are provided for the for the purpose purpose of illustrationonly, of illustration only, and and are not intended are not intended to to be be limiting limiting unless unless otherwise specified. Thus, otherwise specified. Thus,the theinvention invention should shouldinin no no waybe way beconstrued construedasasbeing being limitedtotothe limited the following following examples, examples,but butrather, rather, should should be be construed construed to encompass to anyand encompass any and allvariations all variations which which become become evidentasasa aresult evident result of of the the teaching teaching provided provided
herein. herein.
[00036]
[00036] EXAMPLE EXAMPLE 11
[00037]
[00037] Thefollowing The followingisisananexample example of dosing of dosing to achieve to achieve uptitration uptitration of LSD.ofThis LSD. This is also is also applicable applicable to to other other psychedelics. TABLE psychedelics. TABLE 1 1 shows shows oral oral administration administration over over differentdays different daysand and for different for different times of daily times of daily administration. administration.TheThe dose dose levels levels can translate can translate into into 1) 1) threshold a PK a PK threshold and 2) aa 5-HT2A and 2) 5-HT2A expression expression threshold threshold thatthat can can be tailored be tailored via via other other dosing dosing regiments regiments and and
formulations so formulations that the so that the dosing dosing is is done done in in aa way that patients way that patients never never get get PK levels that PK levels that match match
the (increasing) the (increasing)threshold thresholdforforperceptual perceptual effects. effects.
TABLE11 TABLE Scenario Scenario Day Day 11 2 2 3 3 4 4 5 5 6 6 7-14 7-14 14-28 14-28 29-56 29-56 57-84+ 57-84+ 11 (daily (daily admin) admin) 10 10 10 10 30 30 30 30 50 50 50 50 100 100 200 200 200 200 200 200
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2 (2x/daily (2x/daily admin) 10 20 40 80 100 200 200 200 200 200 12 Aug 2025
2 admin) 10 20 40 80 100 200 200 200 200 200 3 3 20 20 50 100 100 50 100 100 200 200 200 200 200 200 200 200 200 200 200 200
[00038]
[00038] FIGURE FIGURE 1 1 shows shows howhow the the dosedose increases increases over over time time to atothreshold a threshold for for perceptual perceptual
effects. Similar effects effects. Similar effects would bepresent would be presentforforPKPK levels.TABLE levels. TABLE 2 shows 2 shows dosing dosing with an with an
extended releaseformulation. extended release formulation. TABLE22 TABLE Scenario Scenario Day Day 11 2 2 3 3 4 4 5 5 6 6 7 7 14-28 14-28 29-56 29-56 57-84+ 57-84+ 11 Patch #1 Patch #1 Patch Patch #2 #2 Patch #3(high Patch #3 (highdose) dose) Patch #3(high Patch #3 (highdose) dose) (small dose) (mid (mid dose) weekly oror monthly 2025217270
(small dose) dose) weekly monthly 2 2 Patch #1 Patch #1 Patch #2 (mid Patch #2 (mid dose) dose) Patch #3(high Patch #3 (highdose) dose) (small dose) (small dose) weekly or weekly or monthly monthly 3 3 Patch #2 Patch #2 Patch #2 Patch #2 Patch #2 (mid Patch #2 (mid dose) dose) Patch #2 (mid Patch #2 (mid dose) dose) (mid (mid dose) dose) (mid (mid dose) dose) weekly or weekly or monthly monthly
[00039]
[00039] Precise packagingconfigurations Precise packaging configurationscan canbebeused, used, such such as as a dosing a dosing kit kit of of multiple multiple
patches thatcancan patches that be be applied applied at regular at regular intervals intervals eithereither atorhome at home or in a The in a clinic. clinic. The kit design kit design
(i.e., (i.e.,specific specific way thepatches way the patches are are sized, sized, any differences any differences in theirinproperties, their properties, and the actual and the actual
packaging design)can packaging design) canensure ensure adherence adherence andthat and so so patients that patients doinadvertently do not not inadvertently expose expose
themselvestoto aa hallucinogenic themselves hallucinogenic dose. dose.
[00040]
[00040] Throughout Throughout this this application, application, various various publications, publications, including including United United StatesStates patents, patents,
are are referenced by author referenced by author and andyear yearand andpatents patents byby number. number. FullFull citations citations forforthe thepublications publications are listed below. are listed Thedisclosures below. The disclosures of of these these publications publications andand patents patents in their in their entiretiesareare entireties
hereby incorporated hereby incorporated by reference by reference into application into this this application in order in order tofully to more moredescribe fully describe the state the state
of the of the art art to to which this invention which this inventionpertains. pertains.
[00041]
[00041] The invention The inventionhas hasbeen been described described in illustrative in an an illustrative manner, manner, andis ittoisbeto and it be understood that the understood that the terminology, terminology, which has been which has beenused usedisisintended intendedtoto be bein in the the nature nature of of words words
of description of ratherthan description rather thanofoflimitation. limitation.
[00042]
[00042] Obviously, many Obviously, many modifications modifications and and variations variations of present of the the present invention invention are are possible in light possible in light of of the the above teachings. above teachings. It is,therefore, It is, therefore, to to be be understood understood that that within within the scope the scope
of the appended of the appended claims, claims, the the invention invention canpracticed can be be practiced otherwise otherwise than as than as specifically specifically
described. described.
[00043]
[00043] Reference Reference totoany anyprior priorart artinin the thespecification specification is is not not an an acknowledgement acknowledgementor or
suggestionthat suggestion thatthis thisprior priorart artforms formspart partofofthe thecommon common general general knowledge knowledge in any jurisdiction in any jurisdiction or or that this that this prior prior art artcould could reasonably reasonably bebe expected expected to combined to be be combined with with any anypiece other otherofpiece prior of artprior art by by aa skilled skilled person personininthe theart. art.
[00044]
[00044] By wayofofclarification By way clarification and and for for avoidance of doubt, avoidance of doubt, as as used usedherein hereinand and except except
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wherethe thecontext context requires requires otherwise, otherwise, the the term term "comprise" "comprise" and andvariations variations of of the the term, term, such as 12 Aug 2025
where such as
"comprising", "comprises" "comprising", "comprises" and and"comprised", "comprised", areare not not intended intended to exclude to exclude further further additions, additions,
components, integersor components, integers or steps. steps. 2025217270
9
Claims (24)
1. 1. A method A methodofofdosing dosing a psychedelic a psychedelic thatthat avoids avoids the the sideside effects effects of hallucinations of hallucinations andand
perceptual disturbances, perceptual disturbances, including including the the steps steps of: of:
administering thepsychedelic administering the psychedelic to individual to an an individual in aintitrating a titrating dosing dosing regimen; regimen; and and 2025217270
reducing sideeffects reducing side effectsofofhallucinations hallucinationsandand perceptual perceptual disturbances. disturbances.
2. 2. Themethod The method of claim of claim 1, wherein 1, wherein said said administering administering step isstep is further further defineddefined as: as: administering administering a a startingdose starting doseto to thethe individual; individual;
at a set at a set amount amountof oftime, time,increasing increasing thethe dose dose a amount a set set amount and administering and administering the the increased dose increased dose to to thethe individual; individual; andand
repeating said increasing repeating said increasingand and administering administering steps steps overover a period a period of that of time timethe that the individual is being individual is treatedand being treated anduntil untilaamaximum maximum desired desired dose dose is is reached. reached.
3. 3. Themethod The method of claim of claim 2, wherein 2, wherein the starting the starting dose dose is a sub-perceptual is a sub-perceptual dose. dose.
4. 4. The method The methodofofclaim claim2,2,wherein wherein the the startingdose starting doseisis1010µgµg and and is is increased increased by by 10 10 µg µg every periodofoftime. every period time.
5. 5. The method The methodofofclaim claim2,2,wherein whereinthe theperiod periodofoftime timeisis chosen chosenfrom fromthe thegroup groupconsisting consisting of hours, of hours, days, days, weeks, weeks, months, andyears. months, and years.
6. 6. The method The methodofofclaim claim2,2,wherein wherein thedose the dose is is increased increased by by an an amount amount chosen chosen from from the the groupconsisting group consistingofof10, 10,20,20, 30, 30, andand 50 50 µg. µg.
7. 7. The method The methodofofclaim claim1, 1,wherein wherein said said administeringstep administering step is is furtherdefined further definedasas administering a starting administering a starting dose dose of of a a loading loading dose andadministering dose and administeringsubsequent subsequent doses doses of sub- of sub-
perceptual perceptual doses. doses.
10
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8. The method methodofofclaim claim1,1,wherein whereinthe thepsychedelic psychedelicisischosen chosenfrom from thegroup group consistingofof 12 Aug 2025
8. The the consisting
lysergic lysergic acid aciddiethylamide diethylamide (LSD), (LSD), psilocybin, psilocybin,mescaline, mescaline,5-methoxy-N,N-dimethyltryptamine (5- 5-methoxy-N,N-dimethyltryptamine (5-
MeO-DMT), dimethyltryptamine(DMT), MeO-DMT), dimethyltryptamine (DMT), 2,5-dimethoxy-4-iodoamphetamine 2,5-dimethoxy-4-iodoamphetamine (DOI), (DOI), 2,5- 2,5- dimethoxy-4-bromoamphetamie dimethoxy-4-bromoamphetamie (DOB), (DOB), salts salts thereof, thereof, tartrates tartrates thereof, thereof, analogs analogs thereof, thereof, and and homologues thereof. homologues thereof.
9. 9. A kit A kit for for administering administering a atitrating titrating dosing dosingregimen regimenof of a psychedelic, a psychedelic, comprising comprising a a 2025217270
pharmaceutically effective amount pharmaceutically effective of the amount of the psychedelic in dosage psychedelic in formsseparated dosage forms separatedininpackaging packaging according according totodose dose andand timetime of administration of administration in a titrating in a titrating dosing dosing regimen, regimen, and instructions and instructions for for use. use.
10. 10. The kit The kit of of claim claim 9, 9, wherein wherein said saidpsychedelic psychedelicisischosen chosen from from thethe group group consisting consisting of of lysergic lysergic acid aciddiethylamide diethylamide (LSD), (LSD), psilocybin, psilocybin,mescaline, mescaline,5-methoxy-N,N-dimethyltryptamine (5- 5-methoxy-N,N-dimethyltryptamine (5-
MeO-DMT), dimethyltryptamine(DMT), MeO-DMT), dimethyltryptamine (DMT), 2,5-dimethoxy-4-iodoamphetamine 2,5-dimethoxy-4-iodoamphetamine (DOI), (DOI), 2,5- 2,5- dimethoxy-4-bromoamphetamie dimethoxy-4-bromoamphetamie (DOB), (DOB), salts salts thereof, thereof, tartrates tartrates thereof, thereof, analogs analogs thereof, thereof, and and homologues thereof. homologues thereof.
11. 11. The kit The kit of of claim claim 9, 9, wherein said dosage wherein said dosageforms forms include include a startingdose a starting dose andand additional additional
increased doses. increased doses.
12. 12. Thekit The kit ofof claim claim11, 11,wherein wherein saidsaid starting starting dose dose is in is in a different a different color color or sizeorfrom sizesaid from said additional increaseddoses. additional increased doses.
13. 13. Thekit The kit of of claim claim 11, 11,wherein wherein said said additional additional increased increased dosesdoses are a are a single single dosage dosage form or form or multiple multiple separate separate dosage forms. dosage forms.
14. 14. Thekit The kit of of claim claim 9, 9, wherein whereinsaid said packaging packaging indicates indicates whichwhich time period time period each each dose dose should should be takenin. be taken in.
15. 15. Thekit The kit of of claim claim 9, 9, wherein whereinsaid said packaging packaging is a is a blister blister pack. pack.
11
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16. A method method of of treating an an individual with psychedelics, including the steps of: 12 Aug 2025
16. A treating individual with psychedelics, including the steps of:
administering the psychedelic administering the psychedelictotothe theindividual individualhaving having a condition a condition or disease or disease in a in a
titrating dosing titrating dosing regimen; and regimen; and
reducing sideeffects reducing side effectsofofhallucinations hallucinationsandand perceptual perceptual disturbances disturbances during during treatment. treatment.
17. 17. The method The methodofofclaim claim16, 16,wherein whereinthe thecondition conditionorordisease diseasebeing beingtreated treatedisis chosen chosenfrom from the group the group consisting consisting of of anxiety anxiety disorders, disorders, depression, depression, headache headachedisorder, disorder, obsessive obsessive 2025217270
compulsive disorder(OCD), compulsive disorder (OCD),personality personalitydisorders, disorders,stress stress disorders, disorders, drug drug disorders, disorders, gambling gambling disorder, eating disorder, disorder, eating disorder, body bodydysmorphic dysmorphic disorder, disorder, pain,pain, neurodegenerative neurodegenerative disorders, disorders,
movement disorders,autism movement disorders, autismspectrum spectrum disorder,eating disorder, eatingdisorders, disorders, and andneurological neurological disorders. disorders.
18. 18. Themethod The method of claim of claim 16, 16, wherein wherein said said administering administering step isstep is further further defineddefined as: as: administering administering a a startingdose starting doseto to thethe individual; individual;
at a set at a set amount amountof oftime, time,increasing increasing thethe dose dose a amount a set set amount and administering and administering the the increased dose increased dose to to thethe individual; individual; andand
repeating said increasing repeating said increasingand and administering administering steps steps overover a period a period of that of time timethe that the individual is being individual is treatedand being treated anduntil untilaamaximum maximum desired desired dose dose is is reached. reached.
19. 19. Themethod The method of claim of claim 18, 18, wherein wherein the starting the starting dose dose is is a sub-perceptual a sub-perceptual dose. dose.
20. 20. The method The methodofofclaim claim18, 18,wherein whereinthethestarting startingdose doseisis10 10µgµgand andisisincreased increasedbyby 1010 µg µg
every periodofoftime. every period time.
21. 21. The method The methodofofclaim claim18, 18,wherein whereinthe theperiod periodofof time time is is chosen from the chosen from the group groupconsisting consisting of hours, of hours, days, days, weeks, weeks, months, andyears. months, and years.
22. 22. The method The methodofofclaim claim18, 18,wherein whereinthe thedose dose is isincreased increased byby anan amount amount chosen chosen from from the the group consistingofof10, group consisting 10,20,20, 30, 30, andand 50 µg. 50 µg.
23. 23. The method The methodofofclaim claim16, 16,wherein wherein said said administeringstep administering stepisisfurther further defined defined as as administering aa starting administering starting dose dose of of a a loading loading dose andadministering dose and administeringsubsequent subsequent doses doses of sub- of sub-
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perceptual perceptual doses. 12 Aug 2025
doses.
24. 24. The method The methodofofclaim claim16, 16,wherein whereinthe thepsychedelic psychedelicisis chosen chosenfrom fromthe thegroup groupconsisting consistingof of lysergic acid lysergic aciddiethylamide diethylamide (LSD), (LSD), psilocybin, psilocybin,mescaline, mescaline,5-methoxy-N,N-dimethyltryptamine (5- 5-methoxy-N,N-dimethyltryptamine (5-
MeO-DMT), dimethyltryptamine(DMT), MeO-DMT), dimethyltryptamine (DMT), 2,5-dimethoxy-4-iodoamphetamine 2,5-dimethoxy-4-iodoamphetamine (DOI), (DOI), 2,5- 2,5- dimethoxy-4-bromoamphetamie dimethoxy-4-bromoamphetamie (DOB), (DOB), salts salts thereof, thereof, tartrates tartrates thereof, thereof, analogs analogs thereof, thereof, and and homologues homologues thereof. thereof. 2025217270
13
FIGURE 1 FIGURE 1
effects perceptual for Threshold 800 ug range Therapeutic 50 ug 1/1 1/1
Dose level
20 ug Time
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| PCT/US2022/027179 WO2022235529A1 (en) | 2021-05-03 | 2022-05-01 | Method of titrating dose of psychedelics |
| AU2025217270A AU2025217270A1 (en) | 2021-05-03 | 2025-08-12 | Method of titrating dose of psychedelics |
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| AU2022268891A Division AU2022268891A1 (en) | 2021-05-03 | 2022-05-01 | Method of titrating dose of psychedelics |
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| MX2023013928A (en) | 2021-05-25 | 2023-12-08 | Atai Therapeutics Inc | NEW SALTS AND CRYSTALLINE FORMS OF N,N-DIMETHYLTRYPTAMINE SALTS. |
| JP2024522174A (en) | 2021-06-09 | 2024-06-11 | アタイ セラピューティクス， インコーポレイテッド | Novel prodrugs and conjugates of dimethyltryptamine |
| CA3229363A1 (en) | 2021-08-20 | 2023-02-23 | Nicholas KADYSH | Compositions comprising non-racemic mixtures of (r)- and (s)-3,4-methylenedioxymethamphetamine or (r) and (s) n-methyl-1,3-benzodioxolylbutanamine and uses thereof |
| US12012381B2 (en) | 2021-12-30 | 2024-06-18 | Atai Therapeutics, Inc. | Dimethyltryptamine analogues as nitric oxide delivery drugs |
| EP4486448A1 (en) | 2022-03-04 | 2025-01-08 | Reset Pharmaceuticals, Inc. | Co-crystals or salts comprising psilocin |
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| CN106573123B (en) * | 2014-06-30 | 2021-08-31 | Syqe医药有限公司 | Methods, devices and systems for pulmonary delivery of active agents |
| EP3713568A1 (en) * | 2017-10-26 | 2020-09-30 | Consejo Superior de Investigaciones Cientificas (CSIC) | Combination product for the treatment of neurological and/or psychiatric disorders |
| CA3127854A1 (en) * | 2019-01-30 | 2020-08-06 | Judith BLUMSTOCK | Methods and compositions comprising a 5ht receptor agonist for the treatment of psychological, cognitive, behavioral, and/or mood disorders |
| US20220071958A1 (en) * | 2019-02-22 | 2022-03-10 | GH Research Ireland Limited | 5-methoxy-n,n-dimethyltryptamine (5-meo-dmt) for treating depression |
| WO2021003467A1 (en) * | 2019-07-04 | 2021-01-07 | Sw Holdings, Inc. | Metered dosing compositions and methods of use of psychedelic compounds |
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| AU2022268891A1 (en) | 2023-11-09 |
| WO2022235529A1 (en) | 2022-11-10 |
| CA3216939A1 (en) | 2022-11-10 |
| EP4333979A1 (en) | 2024-03-13 |
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