Denifanstat
Metabolic Dysfunction-Associated Steatohepatitis (MASH) with F2/F3 fibrosis
Phase 3-readyEnd-of-Phase 2 interactions with FDA completed; Breakthrough Therapy Designation granted Oct 2024.
Key Facts
Indication
Metabolic Dysfunction-Associated Steatohepatitis (MASH) with F2/F3 fibrosis
Phase
Phase 3-ready
Status
End-of-Phase 2 interactions with FDA completed; Breakthrough Therapy Designation granted Oct 2024.
Company
About Sagimet Biosciences
Sagimet Biosciences is pioneering a novel therapeutic approach by selectively inhibiting the fatty acid synthase (FASN) enzyme, a key regulator of lipid synthesis implicated in multiple diseases. The company's lead asset, denifanstat, has demonstrated statistically significant efficacy in a Phase 2b MASH trial and met all endpoints in a Phase 3 acne trial, supported by FDA Breakthrough Therapy designation for MASH. With a pipeline extending to oncology and a second FASN inhibitor, TVB-3567, entering clinical development for acne, Sagimet is positioned to address significant unmet needs in metabolic, dermatological, and oncological diseases.
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