Sagimet to launch U.S. Phase 3 denifanstat trial H2 2026 after positive China data
Sagimet will initiate a Phase 3 trial of denifanstat for moderate to severe acne in the U.S. in the second half of 2026 following positive 240-patient open-label Phase 3 safety and efficacy results in China. The company reports an ongoing Phase 1 trial of FASN inhibitor TVB-3567 and will pause its MASH program until non-dilutive funding is secured.
1. US Phase 3 Trial Plan
Sagimet plans to submit an IND application for denifanstat in mid-2026 and, upon clearance, initiate a registrational Phase 3 trial in moderate to severe acne patients in the U.S. during the second half of 2026. The oral, once-daily compound aims to be the first innovative oral acne therapy in over forty years.
2. Positive China Safety Data
In January 2026, a 240-patient open-label Phase 3 trial in China demonstrated that 50 mg once-daily denifanstat was generally well tolerated and delivered improvements across all secondary efficacy endpoints at 52 weeks. These topline safety and efficacy findings underpin Sagimet’s U.S. development strategy.
3. TVB-3567 and MASH Financing
The first-in-human Phase 1 trial of FASN inhibitor TVB-3567 is currently ongoing with a view to advancing into Phase 2 in the second half of 2026. Concurrently, further development of the denifanstat–resmetirom combination for MASH will be deferred until non-dilutive funding is secured.