Research

Hormonal

Obeticholic acid (OCA) reduces hepatic fibrosis without worsening NASH, but its efficacy is modest and it carries safety concerns leading to FDA rejection.

Obeticholic acid can reduce liver scarring in pre-cirrhotic NASH, but its modest benefits and side effects (itching, liver toxicity) led to FDA rejection, making it a less favorable option.

GoodQualifiesHIGH confidence
OCA, a farnesoid X receptor agonist, has been demonstrated to reduce hepatic fibrosis without worsening NASH in the 18-month interim analysis of the REGENERATE phase 3 trial... However, in May 2023, the FDA rejected the new drug application of OCA for pre-cirrhotic NASH, concerning safety issues such as hepatotoxicity, cholelithiasis, and pruritus, while its efficacy is modest.
Young Woon Chang et al. · Clinical and Molecular Hepatology · 2023

Why this rating

Based on phase 3 trial interim analysis.

Source

Recent updates on pharmacologic therapy in non-alcoholic fatty liver disease

Young Woon Chang et al. · Clinical and Molecular Hepatology · 2023

DOI 10.3350/cmh.2023.0356

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DOI resolved against Crossref · corpus check 2026-06-10

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