IP Library › Granted Patent US 12,414,967
Granted Patent B2
US 12,414,967 · App. 16/857,338 · Granted Sep 16, 2025

Compositions and methods of treating liver disease

Inventors: Takanori Takebe (Cincinnati, OH); Rie Ouchi (Cincinnati, OH)
Assignee: Children's Hospital Medical Center
A61K35/407A61K9/0029A61K31/575A61P1/16C12N5/0671C12N5/0672C12N5/0696C12N5/0697C12N15/01G01N33/5008A61K45/06C12N2500/36C12N2501/119C12N2506/45
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Quick Facts
Patent No.
US 12,414,967
App. No.
16/857,338
Granted
Sep 16, 2025
Kind
B2
Abstract

Disclosed are methods of treating or reducing the occurrence of a steatohepatitis disorder. The disorder may include, for example, NASH, parenteral nutrition associated liver disease (PNALD), or genetic forms of liver disease. The method may comprise the step of administering a composition comprising obeticholic acid to an individual in need thereof.

Claims (10)

1. A method of treating or reducing the occurrence of a steatohepatitis disorder, including NASH, parenteral nutrition associated liver disease (PNALD), and a genetic form of liver disease, comprising the step of administering a composition comprising obeticholic acid and total parenteral nutrition or peripheral parenteral nutrition to an individual in need thereof, wherein the total parenteral nutrition or peripheral parenteral nutrition comprises a lipid emulsion, and wherein said composition is administered parenterally.

2. The method of claim 1 , wherein said composition is administered in an amount sufficient to reduce or prevent the occurrence of liver cell fibrosis.

3. The method of claim 1 wherein said composition 1 s administered prior to, following, or during administration of parenteral nutrition to said individual in need thereof.

4. The method of claim 1 wherein said composition further comprises a buffer.

5. The method of claim 1 wherein said composition further comprises a carrier.

6. The method of claim 1 wherein said composition 1 s administered intravenously.

7. A parenteral composition comprising

a. total parenteral nutrition (TPN) or peripheral parenteral nutrition (PPN), wherein the total parenteral nutrition or peripheral parenteral nutrition comprises a lipid emulsion; and

b. obeticholic acid.

8. A kit comprising a container, the composition of claim 7 in a dosage form disposed in the container, and instructions for administering said dosage form to an individual diagnosed or suspected of having or developing PNALD.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 20, 2020
From: TAKEBE, TAKANORI; OUCHI, RIE
To: CHILDREN'S HOSPITAL MEDICAL CENTER
Reel/Frame 054113/0094 →
Continuity (4)
Continuation 16343157
Provisional Application 62517414 · Jun 9, 2017
Provisional Application 62417371 · Nov 4, 2016
Related Publication 20210008123A1 · Jan 14, 2021
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