Sagimet Biosciences
SGMTPhase 3Sagimet 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.
AI Company Overview
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.
Technology Platform
Development of selective, oral small-molecule inhibitors of Fatty Acid Synthase (FASN), the key enzyme in the de novo lipogenesis pathway, to treat diseases driven by overproduction of the fatty acid palmitate.
Pipeline Snapshot
1212 drugs in pipeline, 2 in Phase 3
| Drug | Indication | Stage |
|---|---|---|
| denifanstat + Placebo | MASLD | Phase 3 |
| Denifanstat + Placebo | MASH | Phase 3 |
| TVB-2640 25 mg (US) + TVB-2640 50 mg (US) + Placebo (US) + TVB-2640 50 mg (China... | MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis) | Phase 2 |
| TVB-2640 | KRAS Gene Mutation | Phase 2 |
| TVB-2640 | Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease | Phase 2 |
Funding History
4Total raised: $165M
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Competitive Landscape
In MASH, Sagimet competes with Madrigal, 89bio, Akero, and Viking, differentiating via its direct FASN inhibition mechanism. In acne, it offers a potential new oral systemic alternative to isotretinoin. In oncology, it is a early mover in targeting FASN, a pathway linked to tumor aggressiveness and treatment resistance.
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