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.
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
narrative_reviewCited 16×
Read the paper DOI resolved against Crossref · corpus check 2026-06-10
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