生产企业：Bausch Health
Larsucosterol (DUR-928) is an investigational therapy for alcohol-associated liver disease (ALD). The US FDA has awarded larsucosterol both Fast Track and Breakthrough Therapy designations. A Phase III clinical study in severe alcoholic hepatitis was initiated in early 2026, with topline results anticipated in 2028. Based on the projected primary completion timeline of June 2028, the therapy is expected to potentially secure regulatory approval by early 2029. In September 2025, Bausch Health Companies completed its tender offer to acquire DURECT Corporation, the original developer, for approximately USD 63 million upfront plus up to USD 350 million in milestone payments.
Larsucosterol (DUR-928) is an investigational therapy for alcohol-associated liver disease (ALD). The US FDA has awarded larsucosterol both Fast Track and Breakthrough Therapy designations. A Phase III clinical study in severe alcoholic hepatitis was initiated in early 2026, with topline results anticipated in 2028. Based on the projected primary completion timeline of June 2028, the therapy is expected to potentially secure regulatory approval by early 2029. In September 2025, Bausch Health Companies completed its tender offer to acquire DURECT Corporation, the original developer, for approximately USD 63 million upfront plus up to USD 350 million in milestone payments.
Larsucosterol is an endogenous sulfated oxysterol and epigenetic regulator designed to inhibit DNA methyltransferases (DNMT1, DNMT3a, and DNMT3b), thereby reducing pathological hypermethylation associated with alcohol-associated liver disease (ALD). Through its effects on inflammatory signaling, lipid metabolism, and cellular stress pathways, the therapy is intended to minimize hepatocyte damage and promote liver repair in alcoholic hepatitis.
Larsucosterol is being developed for the treatment of severe alcoholic hepatitis (alcohol-associated hepatitis), a form of alcohol-associated liver disease (ALD).
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