Phase 3 clinical trial of denifanstat in moderate to severe acne patients for the U.S. 

planned to initiate in second half of 2026

First-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 ongoing

Further MASH development to be undertaken only upon securing non-dilutive funding

Sagimet to host a KOL event and webcast, April 30 at 2 pm ET

SAN MATEO, Calif., April 27, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (NASDAQ:SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today provided strategic and corporate updates.

Fatty acid synthase (FASN) inhibition, with its ability to reduce sebum production and address local inflammation, represents a potential novel approach to treat moderate to severe acne vulgaris, a condition impacting an estimated 10 million people in the U.S. annually. The Company recently announced positive topline results in the open-label Phase 3 clinical trial conducted and reported by its license partner that evaluated the long-term safety of denifanstat tablets in patients with moderate to severe acne in China.

Recent Corporate Highlights
 

  • Sagimet plans to initiate a Phase 3 clinical trial of denifanstat in moderate to severe acne patients for the U.S. in the second half of 2026, subject to Investigational New Drug (IND) clearance.
  • In January 2026, positive topline results were reported in the open-label Phase 3 trial (n=240) evaluating the long-term safety of 50 mg once-daily denifanstat in patients with moderate to severe acne in China by Sagimet's license partner Ascletis Bioscience Co. Ltd. (Ascletis). Denifanstat was generally well-tolerated, and subjects treated with denifanstat showed improvements in all efficacy endpoints measured at 52 weeks (secondary endpoints of the trial).
  • First-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 is ongoing.
  • The Company also plans to develop a topical formulation of a FASN inhibitor for the potential treatment of acne.
  • In relation to its development program for the combination of denifanstat and resmetirom in metabolic dysfunction associated steatohepatitis (MASH), the Company reported the completion of its Phase 1 PK clinical trial in December 2025. The Company anticipates that the denifanstat and resmetirom combination program will be ready to advance into Phase 2 in the second half of 2026. The Company will undertake no further clinical development in MASH until non-dilutive financing is achieved.
  • In April 2026, Sagimet announced the appointment of Andreas Grauer, MD, as Chief Medical Officer, and the retirement of its former Chief Medical Officer, Eduardo Bruno Martins, MD, DPhil. Dr. Grauer brings more than two decades of global biopharmaceutical leadership experience, with deep expertise spanning clinical development, medical affairs, and regulatory strategy across multiple therapeutic areas.