Sagimet Biosciences Inc. (NASDAQ: SGMT) announced plans to initiate a Phase 3 clinical trial of denifanstat for moderate to severe acne patients in the United States during the second half of 2026, subject to Investigational New Drug clearance.

The clinical-stage biopharmaceutical company said it will file an IND application for denifanstat for acne treatment in mid-2026. The decision follows positive topline results from an open-label Phase 3 trial conducted by license partner Ascletis Bioscience Co. Ltd. in China, which evaluated the long-term safety of 50 mg once-daily denifanstat in 240 patients with moderate to severe acne.

Chief Executive Officer David Happel stated that denifanstat, if approved, would be a once-daily oral medication and represent the first new oral acne treatment in more than 40 years. The company estimates that moderate to severe acne affects approximately 10 million people in the United States annually.

Sagimet also reported that its first-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 is ongoing. The company plans to initiate a Phase 2 trial with TVB-3567 in moderate to severe acne patients in the second half of 2026, pending completion of the Phase 1 trial and regulatory consultation.

Chief Financial Officer Thierry Chauche said the company is prioritizing its dermatology franchise in capital allocation and will pursue non-dilutive funding options for its metabolic dysfunction associated steatohepatitis program. Further MASH development will only proceed upon securing such funding.

The company appointed Andreas Grauer as Chief Medical Officer, replacing Eduardo Bruno Martins, who retired. Sagimet will host a virtual event with Dr. Julie Harper to discuss denifanstat development for acne on April 30 at 2 p.m. ET.