Sagimet Reports 52-Week Denifanstat Acne Data Ahead of U.S. Phase 3 Trial

Key Points

• Sagimet’s license partner Ascletis reported results from a Chinese Phase 3 open-label extension study of denifanstat in moderate to severe acne.
• Among 240 participants, 56.7% met the study’s treatment-success definition at the end of the trial; mean total and inflammatory lesion counts fell 71.8% and 76.9%, respectively, from the original trial baseline.
• No participants permanently stopped treatment because of adverse events, and no drug-related serious adverse events were reported in the extension.
• Sagimet expects screening for its U.S. Phase 3 AURORA trial to begin in October 2026.
• The extension had no placebo control, so its long-term efficacy results cannot establish how denifanstat would have compared with no active treatment over the same period.

Sagimet Biosciences (SGMT) reported positive long-term denifanstat data presented by its license partner, Ascletis, at EADV 2026. The findings add safety and efficacy information for the 50 mg once-daily oral acne treatment as Sagimet prepares a separate Phase 3 trial in the United States.

Denifanstat Acne Study Shows Continued Improvement

The open-label extension enrolled 240 patients from Ascletis’ earlier 12-week randomized Phase 3 trial in China. Of those, 116 had initially received denifanstat and could have up to 52 weeks of total exposure; 124 had initially received placebo before receiving denifanstat for up to 40 weeks in the extension.

At the end of the study, 56.7% of participants met the definition of treatment success: an Investigator’s Global Assessment score of clear or almost clear, with an improvement of at least two points from the original trial baseline. Mean total lesion counts fell 71.8%, while mean inflammatory lesion counts fell 76.9%. Sagimet said both groups continued to improve during the extension.

Long-Term Safety Data Support U.S. Trial Planning

Denifanstat was generally well tolerated in the extension, according to Sagimet. There were no adverse event-related permanent treatment discontinuations or drug-related serious adverse events. Dry skin, reported in 7.1% of participants, and dry eye, reported in 5.9%, were the only treatment-related adverse-event categories with incidence above 5%.

The study’s primary focus was long-term safety; efficacy was assessed through secondary endpoints. Because everyone in the extension received denifanstat, its results should not be read as a 52-week comparison against placebo.

AURORA Phase 3 Trial Will Test Denifanstat in U.S. Patients

Sagimet expects patient screening for AURORA to begin in October 2026, with first enrollment shortly afterward. The U.S. randomized, double-blind, placebo-controlled Phase 3 trial is designed to enroll approximately 800 patients aged 12 and older, including an expected 450 adolescents.

Participants will receive denifanstat 50 mg or placebo once daily for 12 weeks. The trial will assess treatment success and changes in inflammatory and non-inflammatory lesion counts as three co-primary endpoints. Approximately 530 patients who complete that period may enter a 40-week open-label safety extension.

Investor Takeaway: U.S. Results Remain the Key Test

For SGMT investors, the Chinese extension provides longer-term experience with the dose Sagimet plans to use in AURORA. The next milestone is whether U.S. screening and enrollment proceed as planned, followed by results from AURORA’s placebo-controlled portion.

Denifanstat remains an investigational treatment. Ascletis holds exclusive rights in China, while Sagimet is developing it for the rest of the world; the announcement does not provide an AURORA results date or an approval timeline.