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Denifanstat

Metabolic Dysfunction-Associated Steatohepatitis (MASH) with moderate to advanced fibrosis (F2/F3)

Phase 3 ReadyPlanning global Phase 3 following FDA Breakthrough Therapy Designation and end-of-Phase 2 meetings

Key Facts

Indication
Metabolic Dysfunction-Associated Steatohepatitis (MASH) with moderate to advanced fibrosis (F2/F3)
Phase
Phase 3 Ready
Status
Planning global Phase 3 following FDA Breakthrough Therapy Designation and end-of-Phase 2 meetings
Company
Sagimet Biosciences, Sagimet Biosciences, Sagimet Biosciences

About Sagimet Biosciences

Sagimet Biosciences is advancing a novel therapeutic platform centered on the selective inhibition of Fatty Acid Synthase (FASN), a key enzyme in the dysfunctional de novo lipogenesis pathway. The company's lead asset, denifanstat, has achieved critical milestones, including positive Phase 2b biopsy data in MASH (FASCINATE-2), Breakthrough Therapy designation from the FDA, and successful Phase 3 results in acne from a partner-led trial. With a seasoned leadership team and a clear path to Phase 3 in MASH, Sagimet's strategy is to develop first-in-class oral therapies for diseases driven by lipotoxicity, including MASH, acne, and select cancers.

View full company profile

About Sagimet Biosciences

Sagimet Biosciences is advancing a novel therapeutic platform centered on the selective inhibition of Fatty Acid Synthase (FASN), a key enzyme in the dysfunctional de novo lipogenesis pathway. The company's lead asset, denifanstat, has achieved critical milestones, including positive Phase 2b biopsy data in MASH (FASCINATE-2), Breakthrough Therapy designation from the FDA, and successful Phase 3 results in acne from a partner-led trial. With a seasoned leadership team and a clear path to Phase 3 in MASH, Sagimet's strategy is to develop first-in-class oral therapies for diseases driven by lipotoxicity, including MASH, acne, and select cancers.

View full company profile

About Sagimet Biosciences

Sagimet Biosciences is advancing a novel therapeutic platform centered on the selective inhibition of Fatty Acid Synthase (FASN), a key enzyme in the dysfunctional de novo lipogenesis pathway. The company's lead asset, denifanstat, has achieved critical milestones, including positive Phase 2b biopsy data in MASH (FASCINATE-2), Breakthrough Therapy designation from the FDA, and successful Phase 3 results in acne from a partner-led trial. With a seasoned leadership team and a clear path to Phase 3 in MASH, Sagimet's strategy is to develop first-in-class oral therapies for diseases driven by lipotoxicity, including MASH, acne, and select cancers.

View full company profile

Therapeutic Areas

Metabolic DiseaseDermatologyOncology