US2019153020A1PendingUtilityA1

Preparation and Uses of Obeticholic Acid

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Assignee: INTERCEPT PHARMACEUTICALS INCPriority: Jun 19, 2012Filed: Nov 13, 2018Published: May 23, 2019
Est. expiryJun 19, 2032(~5.9 yrs left)· nominal 20-yr term from priority
Inventors:André SteinerHeidi Waenerlund PoulsenEmilie JoliboisMelissa RewolinskiRalf GrossEmma SharpFiona Dubas-FisherAlex Eberlin
A61P 9/10A61P 9/00A61P 31/14A61P 3/06A61P 43/00A61P 1/16A61P 13/04A61K 31/575C07J 51/00C07J 9/005A61K 9/2054C07J 9/00C07B 2200/13A61K 31/56
66
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Claims

Abstract

The present invention relates to obeticholic acid: or a pharmaceutically acceptable salt, solvate or amino acid conjugate thereof. Obeticholic acid is useful for the treatment or prevention of a FXR mediated disease or condition, cardiovascular disease or cholestatic liver disease, and for reducing HDL cholesterol, for lowering triglycerides in a mammal, or for inhibition of fibrosis. The present invention also relates to processes for the synthesis of obeticholic acid.

Claims

exact text as granted — not AI-modified
We claim: 
     
         1 . A tablet comprising a non-crystalline obeticholic acid in the amount of about 1 mg to about 25 mg. 
     
     
         2 . The tablet of  claim 1 , wherein the non-crystalline obeticolic acid is in the amount of about 25 mg. 
     
     
         3 . The tablet of  claim 1 , wherein the non-crystalline obeticolic acid is in the amount of about 10 mg. 
     
     
         4 . The tablet of  claim 1 , wherein the non-crystalline obeticolic acid is in the amount of about 5 mg. 
     
     
         5 . The tablet of  claim 1 , wherein the non-crystalline obeticolic acid is in the amount of about 1 mg to about 5 mg. 
     
     
         6 . The tablet of  claim 1 , wherein the non-crystalline obeticolic acid is in the amount of about 1.2 mg to about 1.8 mg. 
     
     
         7 . The tablet of  claim 1 , wherein the non-crystalline obeticolic acid is in the amount of about 1.3 mg to about 1.7 mg. 
     
     
         8 . The tablet of  claim 1 , wherein the non-crystalline obeticolic acid is in the amount of about 1.5 mg. 
     
     
         9 . The tablet of  claim 1 , wherein the non-crystalline obeticolic acid is in the amount of about 1 mg. 
     
     
         10 . A method for treating NASH comprising administering to a subject in need thereof a tablet comprising a non-crystalline obeticholic acid in the amount of about 1-25 mg in single or divided dose daily. 
     
     
         11 . The method of  claim 10 , wherein the non-crystalline obeticholic acid is in the amount of about 25 mg. 
     
     
         12 . The method of  claim 10 , wherein the non-crystalline obeticholic acid is in the amount of about 10 mg. 
     
     
         13 . The method of  claim 10 , wherein the dose is a single dose daily. 
     
     
         14 . A method of treating biliary atresia comprising administering to a subject in need thereof a table comprising non-crystalline obeticholic acid in the amount of about 1 mg to about 25 mg in single or divided dose daily. 
     
     
         15 . The method of  claim 14 , wherein obeticholic acid is in the amount of about 1 mg to about 5 mg. 
     
     
         16 . The method of  claim 14 , wherein obeticholic acid is in the amount of about 1.2 mg to about 1.8 mg. 
     
     
         17 . The method of  claim 14 , wherein obeticholic acid is in the amount of about 1.3 mg to about 1.5 mg. 
     
     
         18 . The method of  claim 14 , wherein obeticholic acid is in the amount of about 1.5 mg. 
     
     
         19 . The method of  claim 14 , wherein the obeticholic acid in in the amount of about 1 mg. 
     
     
         20 . The method of  claim 14 , wherein the subject is a child.

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