WO2017131252A1 - Pharmaceutical composition for preventing or treating diabetic nephropathy - Google Patents

Abstract

A pharmaceutical composition of the present invention can effectively prevent or treat diabetic nephropathy by: blocking, inhibiting or delaying, in advance, the onset of diabetic nephropathy; or alleviating diabetic nephropathy or inhibiting the progression of diabetic nephropathy.

Description

Pharmaceutical composition for preventing or treating diabetic kidney disease

The present invention relates to a pharmaceutical composition for preventing or treating diabetic kidney disease, including fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof. More specifically, the present invention relates to a pharmaceutical composition capable of preventing or inhibiting progression of diabetic kidney disease and effectively improving various symptoms caused by diabetic kidney disease.

Diabetes is a type of metabolic disease, such as lack of insulin secretion or normal function, characterized by high blood sugar, which increases the concentration of glucose in the blood, and causes various symptoms and signs due to high blood sugar and releases glucose through urine.

Long-term exposure to hyperglycemia can lead to peripheral neuropathy, autonomic neuropathy, macrovascular complications, microvascular complications, and other chronic complications.

Diabetic kidney disease is one of the complications caused by diabetes and is the most important cause of chronic renal failure, and has a large proportion in the causative diseases of dialysis patients.

Diabetic kidney disease is mostly symptomatic in the early stage, and as the progression, there is no obvious symptom except proteinuria in urine test. Thus, the development of diabetic kidney disease is diagnosed by the discovery of fine albuminuria (30-299 mg / 24h of urine albumin secretion).

However, as described above, the time when the symptoms of microalbuminuria is also developed after diabetic kidney disease is significantly progressed, and it is not easy to diagnose diabetic kidney disease early, and is often found after a considerable progression of kidney disease.

Also, in diabetic kidney disease, abnormal proliferation of renal intervascular cells leads to enlarged vascular liver tissue, resulting in thickening of the glomerular and tubular basal membranes, narrowing of glomerular vascular diameter, increased glomerular vascular epilepsy, accumulation of extracellular lipids, As the symptoms of glomerulosclerosis and tubulointerstitial fibrosis progress, kidney function gradually weakens, eventually leading to chronic kidney failure.

Another clinical significance of diabetic kidney disease is the significant increase in mortality. The mortality rate of normal type 1 diabetic patients with overt proteinuria is significantly higher than that of normal type 1 diabetic patients with normal albuminuria. That is, among the diabetic patients, the mortality rate is significantly increased in patients with diabetic kidney disease.

Such diabetic kidney disease is increasing in the proportion of kidney disease with the increase in the number of diabetic patients, especially kidney disease caused by type 2 diabetes continues to increase.

To date, however, there are still few drugs that have an effective prophylactic or therapeutic effect on diabetic kidney disease, and conventionally used drugs have long-term side effects such as hyperkalemia and even functional or organ renal artery stenosis. May cause acute renal failure.

Therefore, the development of new drugs for the safe and effective prevention and treatment of diabetic kidney disease is very important.

[Preceding technical literature]

[Patent Documents]

Republic of Korea Patent Registration No. 0354654

[Non-Patent Documents]

Cardiovasc Diabetol. 2009 Jan 21; 8: 4, Gurney AM

Metabolism. 1979 Nov; 28 (11): 1075-7, Somani P et al.

An object of the present invention is to provide a pharmaceutical composition for preventing or treating diabetic kidney disease, including fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof.

It is an object of the present invention to provide a use for preventing or treating diabetic kidney disease of fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof.

It is an object of the present invention to provide a method for preventing or treating diabetic kidney disease by administering to a subject a pharmaceutical composition comprising fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof.

The present invention provides a pharmaceutical composition for preventing or treating diabetic kidney disease, including fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof.

In the present invention, the diabetic nephropathy refers to a renal disorder occurring in a patient with diabetes and is a representative complication caused by diabetes. The disease is caused by hyperglycemia caused by diabetes, which damages the glomeruli inside the kidney and decreases kidney function.

Diabetic kidney disease, in addition to the detection of fine albuminuria in the urine does not show any special symptoms, the treatment is generally delayed, resulting in chronic renal failure leading to a state requiring a kidney transplant or death.

Therefore, in the case of diabetic kidney disease, it is important to prevent the subject with diabetes from developing the diabetic kidney disease or delay the occurrence of diabetic kidney disease as much as possible. In addition, when diabetic kidney disease develops, it is important to prevent the symptoms from worsening or to prevent the symptoms from worsening or to inhibit the progression of diabetic kidney disease or to slow the progression of the disease.

A pharmaceutical composition comprising fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof can effectively prevent or treat kidney disease caused by diabetes. As a result, it is possible to prevent or inhibit the development of kidney disease in a subject with diabetes or to delay the onset, or to improve symptoms of diabetic kidney disease in a subject with diabetic kidney disease, and to develop a kidney disease. It can prevent the exacerbation of the disease by inhibiting the progression or slowing the progression of the disease.

Therefore, the composition according to the present invention can prevent the diabetic kidney disease leading to chronic renal failure can significantly lower the mortality rate of the patient. In addition, if diabetic kidney disease leads to chronic renal failure, it may eventually lead to dialysis. A pharmaceutical composition comprising fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof may inhibit or progress the diabetic kidney disease. Delay can delay the start of such dialysis.

In the present invention, the prophylaxis refers to any action that prevents or suppresses the occurrence of diabetic kidney disease or a symptom or delays the onset by administration of the pharmaceutical composition according to the present invention. For example, when the composition of the present invention is administered to a subject who has diabetes but does not develop diabetic kidney disease, it may prevent or delay the occurrence of diabetic kidney disease or its symptoms.

In the present invention, the treatment improves and improves diabetic nephropathy or a symptom thereof by administering the pharmaceutical composition according to the present invention, or inhibits or delays the progression of diabetic nephropathy by treating the diabetic nephropathy. It means any act that suppresses deterioration. For example, when the composition of the present invention is administered to a subject suffering from diabetic kidney disease, diabetic kidney disease or the symptoms thereof may be alleviated or improved. Alternatively, when the composition of the present invention is administered to a subject who develops diabetic kidney disease, diabetic kidney disease or symptoms thereof may be inhibited or delayed to inhibit exacerbation of diabetic kidney disease, and as a result, chronic renal failure. This can significantly reduce mortality from diabetic kidney disease and slow the start of dialysis.

In the present invention, the treatment includes reducing mortality due to diabetic kidney disease or delaying the onset of dialysis.

The composition of the present invention may prevent the occurrence of albuminuria, proteinuria or reduce or delay the increase in the amount of albuminuria, proteinuria when administered to a subject with diabetes or a subject with diabetic kidney disease.

When the composition of the present invention is administered to a subject with diabetes or a subject with diabetic kidney disease, it is possible to prevent or reduce the creatine and blood urea nitrogen levels in the serum, or to increase the levels. Can be delayed.

When the composition of the present invention is administered to a subject with diabetes or a subject with diabetic kidney disease, nephron damage, hardening of the glomeruli and fibrosis, thickening of the glomerular basement membrane, fear degeneration and necrosis of the tubules, thickening of the tubular basement membrane, Injury, Tubulointerstitial Fibrosis, Hydronephrosis, and increased kidney volume can be prevented and symptoms can be ameliorated, or symptoms can be suppressed or delayed to prevent exacerbation.

When the composition of the present invention is administered to a subject with diabetes or a subject with diabetic kidney disease, it is possible to prevent local inflammation of renal cells, or to improve inflammation of renal cells, and to inhibit or delay progression of inflammation. To prevent deterioration.

When the composition of the present invention is administered to a subject with diabetes or a subject with diabetic kidney disease, it is possible to prevent the accumulation of proteins in the tubules, or to improve the symptoms of protein accumulation in the tubules or to delay protein accumulation. have.

When the composition of the present invention is administered to a subject with diabetes or a subject with diabetic kidney disease, it is possible to prevent an increase in mesial cells or accumulation of extracellular matrix proteins, and improve or suppress the symptoms as described above. Or delay.

The composition of the present invention, when administered to a subject with diabetes or a subject with diabetic kidney disease, prevents the occurrence of edema, itching and uremic symptoms caused by kidney disease, or reduces or reduces the edema, itching and uremic symptoms It may delay the worsening of itching and uremic symptoms.

When the composition of the present invention is administered to a subject having diabetes or diabetic kidney disease, anorexia and fatigue caused by kidney disease may be reduced and improved, and anorexia and fatigue caused by kidney disease may be delayed.

When the composition of the present invention is administered to a subject with diabetic kidney disease, it can prevent or delay the progression of diabetic kidney disease, thereby preventing or delaying chronic renal failure, and as a result, significantly lowering the mortality rate of the subject or starting dialysis. It can delay the timing.

The composition of the present invention can sufficiently or effectively prevent or treat diabetic kidney disease even if only fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof is used as an active ingredient.

The compositions of the present invention exhibit sufficient safety for long term administration to a subject. For example, the composition of the present invention does not cause hyperkalemia and irregular heart rhythm or cardiac arrest due to prolonged administration to a subject with diabetes or a subject with diabetic kidney disease. It does not cause kidney failure, such as acute renal failure, and has little or no toxicity including other side effects. Accordingly, fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof according to the present invention can be safely administered to a subject with diabetes or diabetic kidney disease for a long time.

In the present invention, a subject refers to an animal, including a human, for example mice, rats, other rodents, rabbits, dogs, pigs, cats, cattle, sheep, horses, primates and humans. It may be a mammal comprising, preferably a primate or a human, more preferably a human.

In the present invention, the diabetes may be insulin-dependent type 1 diabetes or insulin-independent type 2 diabetes.

In the present invention, the fimasaltan may be a compound represented by the following Chemical Formula 1.

Formula 1

In the present invention, the pharmaceutically acceptable salts generally mean inorganic acid salts, organic acid salts, and metal salts used by pharmaceutical manufacturers to prepare pharmaceuticals. As the inorganic acid, hydrochloric acid, bromic acid, sulfuric acid, or phosphoric acid may be used. Organic acids include citric acid, acetic acid, lactic acid, tartaric acid, fumaric acid, formic acid, propionic acid, oxalic acid, trifluoroacetic acid, methanesulfonic acid, benzenesulfonic acid, maleic acid, benzoic acid, gluconic acid, glycolic acid, succinic acid, and 4-morpholine ethanesulfonic acid. , Camphorsulfonic acid, 4-nitrobenzenesulfonic acid, hydroxy-O-sulfonic acid, 4-toluenesulfonic acid, kalukturonic acid, emboic acid, glutamic acid, aspartic acid, adipic acid or campylic acid, and the like, and the metal is sodium, Potassium, calcium or magnesium can be used.

In the present invention, the salt of fimasartan may be preferably potassium salt of potassium, hydrochloride, calcium salt, sulfate, adipate salt, camsylate salt or besylate salt, and more preferably potassium salt. These can be purchased commercially, and can be prepared by a known method (for example, Korean Patent Registration No. 0354654).

In the present invention, the hydrate may comprise a stoichiometric or nonstoichiometric amount of water bound by non-covalent intermolecular forces.

In the present invention, the solvate may comprise a stoichiometric or nonstoichiometric amount of solvent bound by non-covalent intermolecular forces. The solvent means a conventional organic solvent used for preparing an organic compound, for example, methanol, ethanol, 1-propanol, 2-propanol, 1-butanol, 2-butanol, 1-acetate, acetone, acetic acid, annihilate Sol, tetrahydrofuran, methyl acetate, ethyl acetate, propyl acetate, isopropyl acetate, isobutyl acetate, n-butyl acetate, dimethyl sulfoxide, pentane, heptane, and the like, but examples of the solvate of the present invention are limited. It is not.

In the present invention, the hydrate and the solvate may contain water or a solvent in a ratio of 0.25 to 10 moles with respect to 1 mole of potassium masumatan, for example 0.5 mole, 1 mole, 1.5 mole, 2 mole, 2.5 mole , 3 mol, 5 mol, and the like, and more preferably 1 mol or 3 mol of water with respect to 1 mol of fimasartan potassium. For example, the pharmaceutical composition may be prepared using fimasartan potassium salt monohydrate or fimasartan potassium salt trihydrate.

In the present invention, the pharmaceutical composition may include fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof in an amount of 5 wt% to 60 wt% with respect to the total weight of the composition, preferably 10 It may be included in the weight% to 50% by weight.

In the present invention, the pharmaceutical composition may further include a pharmaceutically acceptable additive. The pharmaceutically acceptable is a physiologically acceptable and when administered to a human, usually in the manufacture of self-pharmaceutical compositions having ordinary knowledge in the art without causing gastrointestinal disorders, allergic reactions such as dizziness or the like. In use, reference may be made to Remington's Pharmaceutical Science (latest version), Mack Publishing Company, Easton PA.

The additives may be carriers, excipients, extenders, antioxidants, buffers, fillers, anticoagulants, lubricants, wetting agents, fragrances, emulsifiers, suspending agents, surfactants and preservatives. For example, the additive may include lactose, dextrose, calcium silicate, corn starch, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, Methyl cellulose, polyvinylpyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, stearic acid, magnesium stearate, calcium stearate, mineral oil, saline solution, glucose aqueous solution, analogous aqueous solution, alcohol, glycol , Ethers (eg polyethylene glycol 400), oils, fatty acids, fatty acid esters, glycerides or mixtures thereof. However, the additives which may be included in the composition according to the present invention are not limited to the above-listed materials, which are merely exemplary.

The pharmaceutical compositions of the present invention may be formulated according to conventional methods, may be prepared as oral dosage forms or parenteral dosage forms, and may preferably be oral dosage forms.

In the present invention, the preparation for oral administration may be a solid preparation such as tablets, pills, powders, granules, capsules, or liquid preparations such as suspensions, solvents, emulsions, and syrups, and preferably solid preparations. Most preferably, more preferably a tablet.

When the pharmaceutical composition of the present invention is formulated as an oral solid preparation, examples of the additives used are cellulose, calcium silicate, corn starch, lactose, sucrose, dextrose, calcium phosphate, stearic acid, magnesium stearate, calcium stearate , Gelatin, talc and the like.

When the pharmaceutical composition is formulated as a liquid preparation for oral administration, the pharmaceutical composition may be formulated by adding various additives such as water, liquid, and simple diluent such as paraffin, wetting agent, sweetener, fragrance, preservative, preservative, and colorant. Can be.

When the pharmaceutical composition of the present invention is prepared in the form of injectables, the additives include water, saline solution, aqueous glucose solution, pseudoglucose solution, alcohol, glycol, ether (e.g. polyethylene glycol 400), oil, fatty acid, fatty acid ester, glycerol Ride etc. are mentioned.

In the present invention, the content of the additive included in the pharmaceutical composition is not particularly limited and may be appropriately adjusted within the content range used in conventional formulation.

In the present invention, the pharmaceutical composition may include fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof such that the content of fimasartan is about 1 mg to 240 mg, preferably about 30 mg. To 180 mg may be included.

In the present invention, the pharmaceutical composition may be administered orally or parenterally (eg, applied intravenously, subcutaneously, intraperitoneally or topically), and the dosage is weight, age, sex, health of the patient. The range may vary depending on the condition, diet, administration time, administration method, administration period or interval, excretion rate, constitution specificity, nature of the preparation, severity of disease, and the like. For example, the dose of fimasartan may be about 1 to 240 mg, preferably 30 to 180 mg per day, based on a normal adult weight of about 60 kg, and the application may be applied once or several times a day. have.

In the present invention, the pharmaceutical composition may further include an active ingredient having other pharmacological activity in addition to the fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof.

The composition of the present invention may further include an antihypertensive agent, a diuretic agent, a hyperlipidemic agent, an anti-obesity agent, or an antidiabetic agent in addition to the fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof. For example, the composition of the present invention can be used as an active ingredient with pimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof, such as amlodipine, nifedipine, verapamil, diltiazem, nicardipine, lercardidipine, atorvastatin , Cerivastatin, fluvastatin, lovastatin, pitavastatin, simvastatin, roschvastatin, nicotinic acid, theophylline, caffeine, theobromine, aminophylline, hydrochlorothiazide, bendroflumetiazide, allogliptin, saxagliptin , Citagliptin, metformin, exenatide, rosiglitazone, pioglitazone, tolbutamide, troglitazone, leptin, ephedrine, fenfluramine, fluoxetine, and the like.

The pharmaceutical composition of the present invention may be used alone or in combination with methods using surgery, hormone therapy, drug treatment and biological response modifiers for the improvement, alleviation, treatment or prevention of diabetic kidney disease.

The present invention provides a use for the prophylaxis or treatment of diabetic kidney disease of fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof.

The present invention provides a method for preventing or treating diabetic kidney disease by administering to a subject a pharmaceutical composition comprising fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof.

In the uses and methods of the present invention, the pharmaceutical composition and fimasartan, pharmaceutically acceptable salts thereof, or hydrates or solvates thereof as described above are as described above.

The pharmaceutical composition according to the present invention includes fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof, and thus can effectively prevent or treat diabetic kidney disease. The pharmaceutical composition according to the present invention may block or inhibit the development of diabetic kidney disease in advance, and may also improve or inhibit the progression or worsening of the diabetic kidney disease.

1 and 2 are diagrams showing a decrease in albumin content in urine following administration of the pharmaceutical composition of the present invention in rats.

Hereinafter, examples will be described in detail to help understand the present invention. However, the following examples are merely to illustrate the content of the present invention is not limited to the scope of the present invention. The embodiments of the present invention are provided to more completely explain the present invention to those skilled in the art. The experimental results of each example were statistically processed using one way analysis of variance (ANOVA), and if significance was recognized, p <0.05 (* or †) or p <0.01 (**) level using Dunnett's multiple comparison test. The significance test was performed below.

1. Preparation of experimental animals

(1) Selection of laboratory animals

8 weeks-old spontaneously hypertensive rats (SHR) of 245 to 260 g were supplied with temperature 22 ± 3 ℃, humidity 55 ± 15%, ventilation frequency 10-20 times / hr, lighting time 12 hours (am 8 hours on-8 pm off) and roughness 150-300 Lux breeding. During the breeding period, feed was fed from Dreambio for feed for experimental animals produced by Cargill Agripurina Co., Ltd. Water was freely ingested purified water using a polycarbonate drinking bottle. Subsequently, 19 healthy rats were selected for use in the experiment, and classified into the first group (6), the second group (6) and the third group (7).

(2) induction of diabetic kidney disease

Streptozotocin (STZ) was used to induce diabetic nephropathy in rats (Gurney AM, Cardiovasc Diabetol. 2009 Jan 21; 8: 4; Somani P et al., Metabolism. 1979 Nov; 28 (11): 1075-7). Streptozotocin causes diabetes by destroying beta cells in the pancreas upon intraperitoneal or intravenous administration.

Streptozotocin was administered to the second and third groups. The individual was fasted a day through the fasting plate one day before the streptozotocin administration. Individuals who fasted the composition containing streptozotocin dissolved in 0.1 M sodium citrate buffer (pH 4.5) were administered at a volume of 1 mL / kg so that the streptozotocin content per head was 50 mg / kg immediately after fasting blood glucose measurement.

Fasting blood glucose was measured 48 hours after streptozotocin administration, and it was determined that diabetes was induced when the blood glucose level was 250 mg / dl or more.

2. Administration of Drugs

48 hours after streptozotocin administration, the induction of diabetes was confirmed and the drug was administered.

The solution prepared by dissolving fimasartan potassium salt trihydrate in a 0.5% (v / v) aqueous solution of carboxymethyl cellulose (SAMCHUN PURE CHEMICAL CO., LTD.) In group 3 rats had a content of 10 mg / Kg / day was administered once daily at 4mL / kg for 24 weeks.

In the first and second groups, 0.5% (v / v) of carboxymethyl cellulose (SAMCHUN PURE CHEMICAL CO., LTD.) Was administered at a dose of 4 mL / Kg / day, respectively.

Carboxylic methyl cellulose solution and fimasaltan were administered orally to each group before 4 pm daily. In oral administration, animals were fixed by transdermal skin fixation and administered directly into the stomach using sonde for oral administration.

<Example 1> Confirmation of the prevention and treatment effect of Fimasartan for diabetic kidney disease 1

Urine tests were performed at 2 week intervals for each group of rats administered with aqueous solution of carboxymethyl cellulose or fimasartan for 24 weeks. After the rats of each group were collected in a metabolism cage for 24 hours to collect urine, the creatinine amount (CRE) and urine albumin amount (UAE) of urine were measured using a blood biochemical analyzer (7020 Hitachi, Japan). The urinary albumin amount (UAE) is shown in FIG. 1, and the ratio of urinary albumin amount (UACR) to creatinine amount in urine is shown in FIG. 2.

As can be seen in Figures 1 and 2, in the case of the second group and the third group to which the streptozotocin was administered compared to the first group not administered the streptozotocin content of albumin in urine increased diabetes It can be seen that the kidney disease caused by. However, in the third group treated with fimasartan, the albumin content in the urine was significantly reduced compared to the second group in which diabetes was induced by streptozotocin.

In general, the most common symptom of diabetic kidney disease is the detection of albumin in urine, while pimasartan reduced albumin content in urine when administered to a subject with diabetic kidney disease. It can be seen that the disease can be prevented or significantly improved.

Example 2 Confirmation of Prevention and Treatment Effects of Fimasartan on Diabetic Kidney Disease 2

After administering the drug for 24 weeks to the first to third groups, histopathological examination was performed on the rats of each group.

Tissue specimens for histopathological examination were prepared by distinguishing the left kidney from the right kidney. The right kidney was trimmed perpendicular to the constriction and the left elongation was trimmed parallel to the constriction. The cut sample tissues were fixed to 10% neutral formalin solution for 24 hours, and then cut to a thickness of 3 mm. Paraffin-embedded tissues cut to a thickness of 3 mm were paraffin embedded, and 4 μm tissue sections were prepared using a microtom. After staining with Hematoxylin & Eosin (H & E), histopathological examination was performed using an optical microscope (Olympus, BX41, Japan).

Six tissue samples were obtained from the first group, eight from the second group, and eight from the third group, and histopathological examination was performed to confirm the degree of fear degeneration and necrosis of the tubules.

The evaluation of histopathological examination was given by classifying the degree of lesion into none (0), minimum (1), small (2), moderate (3) and conspicuous (4). 1 to 3 are shown.

Table 1: First Group

(R: right kidney, L: left kidney)

Table 2: Group 2

(R: right kidney, L: left kidney)

Table 3: Third Group

(R: right kidney, L: left kidney)

As can be seen in Tables 1 to 3, when looking at the second group and the third group to which streptozotocin (streptozotocin, STZ) was administered, the third group to which fimasartan was administered, such as the degeneration of the tubule The lesions were significantly reduced compared to the second group.

From this, it can be seen that fimasartan can significantly reduce the incidence of renal cell lesions in diabetic kidney disease, and can significantly delay and improve the progression of diabetic kidney disease.

The pharmaceutical composition according to the present invention includes fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof, and thus can effectively prevent or treat diabetic kidney disease. The pharmaceutical composition according to the present invention may block or inhibit the development of diabetic kidney disease in advance, and may also improve or inhibit the progression or worsening of the diabetic kidney disease.

Claims (7)

A pharmaceutical composition for preventing or treating diabetic kidney disease, comprising fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof. The pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable salt is Pimasaltan potassium salt. The pharmaceutical composition of claim 1, wherein the hydrate is fimasartan potassium salt trihydrate. The pharmaceutical composition of claim 1, wherein the composition further comprises a pharmaceutically acceptable additive. The pharmaceutical composition of claim 1, wherein the composition is for oral administration. The pharmaceutical composition of claim 1, wherein the composition comprises fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof in an amount of 5% to 60% by weight based on the total weight of the composition. A method of preventing or treating diabetic kidney disease by administering to a subject a pharmaceutical composition comprising fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof.

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