About
Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic and fibrotic pathways in diseases 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 metabolic dysfunction-associated steatohepatitis (MASH), acne and select forms of cancer.
We are developing a combination of our oral once-daily FASN inhibitor, denifanstat, and the thyroid hormone receptor beta (THR-β) agonist, resmetirom (commercially available as Rezdiffra), for cirrhotic patients living with F4-stage cirrhotic MASH, for which there are no approved treatments. We announced positive topline results for FASCINATE-2, a Phase 2b clinical trial of denifanstat in biopsy-confirmed MASH patients.
FASCINATE-2 was a Phase 2b clinical trial of denifanstat in biopsy-confirmed MASH patients with moderate to advanced fibrosis (F2/F3) at week 52. In this trial, denifanstat, an oral, selective FASN inhibitor, showed statistically significant improvements relative to placebo on both of the primary endpoints of MASH resolution without worsening of fibrosis with ≥2-point reduction in NAS, and ≥2-point reduction in NAS without worsening of fibrosis.
Denifanstat-treated patients also showed statistically significant fibrosis improvement by ≥ 1 stage with no worsening of MASH, and a greater proportion of MRI-derived proton density fat fraction (MRI-PDFF) ≥30% responders relative to placebo.
Denifanstat impacts key drivers of MASH
In addition to MASH, we are exploring the use of our FASN inhibitors in acne and in select forms of cancer; disease areas in which dysregulation of fatty acid metabolism also plays a key role.Â
Acne
In June 2025, we reported that denifanstat met all primary and secondary endpoints in a Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris conducted by Sagimet’s license partner Ascletis Bioscience Co. Ltd. (Ascletis) in China. Ascletis reported that denifanstat was generally well-tolerated. The Phase 3 clinical trial (NCT06192264) was a randomized, double-blind, placebo-controlled, multicenter clinical trial in China to evaluate the safety and efficacy of denifanstat for the treatment of patients with moderate to severe acne. The 480 enrolled patients were randomized 1:1 into two treatment arms to receive denifanstat 50mg or placebo, once daily for 12 weeks.
In December 2025, Ascletis announced that the China National Medical Products Administration (NMPA) accepted its New Drug Application (NDA) for denifanstat for the treatment of moderate to severe acne.
In January 2026, Ascletis reported positive topline results in the open-label Phase 3 trial evaluating the long-term safety of ASC40 (denifanstat) tablets in patients with moderate to severe acne in China.
In June 2025, we initiated a first-in-human Phase 1 clinical trial of our potent and selective small molecule FASN inhibitor, TVB-3567, for development of an acne indication. The Phase 1 clinical trial is a randomized double-blind placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TVB-3567 in healthy participants with or without acne.Â
Cancer
Our FASN inhibitor denifanstat has demonstrated activity against select forms of cancer in pre-clinical and clinical studies.
*Sagimet is derived from a combination of Sagitta and metabolism. In Greek mythology, Sagitta is the arrow used to stop the eagle sent by Zeus to perpetually gnaw on Prometheus’ liver as punishment for gifting fire to humans. Our therapeutic focus targets dysfunctional metabolic pathways.
