FORMULATIONS OF LIXIVAPTAN FOR THE TREATMENT OF POLYCYSTIC DISEASE

1 . A method of treating a polycystic disease in a human subject, said method comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising lixivaptan or a pharmaceutically acceptable salt, prodrug, solvate, cocrystal, conformer, polymorph, crystalline form, tautomer, or hydrate thereof, and a pharmaceutically acceptable carrier in a divided dose regimen, wherein the total daily dose is between about 200 mg and about 500 mg.

2 . The method of claim 1 , wherein the divided dose regimen consists of a first dose and a second dose.

3 . The method of claim 2 , wherein the first dose is between 125 mg and 325 mg lixivaptan.

4 . The method of claim 2 , wherein the second dose is between 75 mg and 175 mg lixivaptan.

5 . The method of claim 2 , wherein the first dose is 200 mg lixivaptan.

6 . The method of claim 2 , wherein the second dose is 100 mg lixivaptan.

7 . The method of any one of claims 2 - 6 , wherein the second dose is administered about eight hours after the first dose.

8 . The method of any one of claims 2 - 6 , wherein the second dose is administered about ten hours after the first dose.

9 . The method of any one of claims 2 - 6 , wherein the second dose is administered about twelve hours after the first dose.

10 . The method of any one of claims 2 - 9 , wherein the first dose is administered in the morning.

11 . The method of any one of claims 2 - 10 , wherein the second dose is administered in the evening.

12 . The method of any one of claims 1 - 11 , wherein the composition is administered for at least one week.

13 . The method of any one of claims 1 - 11 , wherein the composition is administered for at least two weeks.

14 . The method of any one of claims 1 - 11 , wherein the composition is administered for at least one month.

15 . The method of any one of claims 1 - 14 , wherein the polycystic disease is polycystic kidney disease or polycystic liver disease.

16 . The method of claim 15 , wherein the polycystic kidney disease is autosomal dominant polycystic kidney disease (ADPKD).

17 . A pharmaceutical composition for treating a polycystic disease in a human subject in need thereof, the pharmaceutical composition comprising a therapeutically effective amount of lixivaptan, or a pharmaceutically acceptable salt, prodrug, solvate, cocrystal, conformer, polymorph, crystalline form, tautomer, or hydrate thereof, and a pharmaceutically acceptable carrier, wherein the therapeutically effective amount is about 200 mg to about 500 mg lixivaptan delivered in a divided dose regimen.

18 . The pharmaceutical composition of claim 17 , wherein the polycystic disease is polycystic kidney disease or polycystic liver disease.

19 . The pharmaceutical composition of claim 18 , wherein the polycystic kidney disease is autosomal dominant polycystic kidney disease (ADPKD).

20 . Use of a pharmaceutical composition for treating a polycystic disease in a human subject in need thereof, wherein the pharmaceutical composition comprises a therapeutically effective amount of lixivaptan, or a pharmaceutically acceptable salt, prodrug, solvate, cocrystal, conformer, polymorph, crystalline form, tautomer, or hydrate thereof, and a pharmaceutically acceptable carrier, wherein the therapeutically effective amount is about 200 mg to about 500 mg lixivaptan delivered in a divided dose regimen.

21 . The use of claim 20 , wherein the polycystic kidney disease is autosomal dominant polycystic kidney disease (ADPKD).