05:43 AM EDT, 06/04/2025 (MT Newswires) -- Sagimet Biosciences ( SGMT ) said Wednesday that denifanstat met all primary and secondary endpoints in a phase 3 clinical trial to treat moderate to severe acne vulgaris.

The trial was conducted by the company's license partner Ascletis Bioscience in China.

Denifanstat was generally well-tolerated, the company said. After 12 weeks of once-daily oral administration at 50 milligrams, the incidence rates of treatment-emergent adverse events were "comparable" between denifanstat and placebo, Sagimet said.

Building on the phase 3 results, Sagimet recently launched a phase 1 first-in-human clinical trial with a second oral FASN inhibitor drug candidate, TVB-3567, which is planned to be developed for acne in the US.

Sagimet said Ascletis intends to submit denifanstat for approval to the China National Medical Products Administration.

Sagimet shares were up nearly 56% in recent premarket activity.