Denifanstat met all primary and secondary endpoints and was well-tolerated in moderate-to-severe acne vulgaris, according to a Phase 3 clinical trial in acne in China.
Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor being developed by Ascletis as ASC40 for acne in China and by Sagimet for metabolic dysfunction-associated steatohepatitis (MASH) in the rest of world.
The Phase 3 clinical trial enrolled 480 patients who were randomized 1:1 into two treatment arms to receive denifanstat 50mg or placebo, once daily for 12 weeks. Primary endpoints included the percentage of treatment success defined as:
- An Investigator’s Global Assessment (IGA) score of 0 (Clear) or 1 (Almost Clear) with at least a two-point decrease from baseline
- The percentage change in total lesion count
- The percentage change in inflammatory lesion count
Denifanstat met all primary and secondary endpoints and was generally well-tolerated.
At Week 12, treatment success rates with denifanstat were more than double those of placebo, with marked reductions in both inflammatory and non-inflammatory lesions.
Ascletis completed the pre-New Drug Application (NDA) consultation with China National Medical Products Administration (NMPA) for denifanstat for the treatment of moderate-to-severe acne vulgaris in October 2025 and plans to submit an NDA soon.
In June 2025, Sagimet initiated a Phase 1 first-in-human clinical trial with a second FASN inhibitor, TVB-3567, that it plans to develop for patients with moderate-to-severe acne.
The study was presented at the 2025 Fall Clinical Dermatology Conference in Las Vegas, NV.
