We are a clinical-stage biopharmaceutical company

developing novel fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic and fibrotic pathways in conditions resulting from the overproduction of the fatty acid, palmitate. FASN is a regulator of lipid synthesis, and a key pathway implicated in multiple diseases, such as acne, metabolic dysfunction-associated steatohepatitis (MASH), and certain FASN-dependent tumor types.

Denifanstat

Our lead product candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor with a differentiated method of action with the potential to target multiple underserved diseases. Strong clinical data demonstrates denifanstat’s proof of concept across multiple disease states. Sagimet plans to file an Investigational New Drug (IND) Application for denifanstat for the treatment of moderate to severe acne in mid-2026. Following IND clearance, Sagimet anticipates advancing denifanstat into a registrational Phase 3 trial in moderate to severe acne patients in 2H 2026.

Development Pipeline: Indications and Clinical Milestones

Stage of Development

Therapeutic area

Indication

Preclinical

Phase 1

Phase 2

Phase 3

Dermatology

Denifanstat Phase 3 for the US expected to initiate in 2H 2026
TVB-3567 Phase 1 FIH initiated in June 2025
FASNi Topical*

Denifanstat (ASC40)

Metabolic
disease

Denifanstat Phase 3 ready (F2/F3MASH)
Denifanstat Ph1 hepatic impairment study complete
Denifanstat/resmetirom Ph 1 PK trial complete

Oncology

TVB-3567
Denifanstat

*FASN inhibitor Topical Formulation

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VIRTUAL KOL EVENT

A New Mechanism of Action in Treating Acne: Update on Positive Phase 3 Denifanstat Trial for the Treatment of Moderate to Severe Acne

Monday, June 16, 2025 | 2:00 PM ET