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Ocaliva (obeticholic acid), a first-in-class FXR agonist, remains FDA-approved as a second-line treatment for primary biliary cholangitis. The company discontinued its NASH program after multiple FDA rejections. A fixed-dose combination of obeticholic acid and bezafibrate for PBC has received orphan drug designation and remains in development. The pipeline also includes next-generation FXR agonists such as INT‑787 for severe alcohol-associated hepatitis.
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