Denifanstat, a once-daily oral fatty acid synthase inhibitor for moderate-to-severe acne, showed sustained improvement through 52 weeks in an extension trial. Sagimet now plans the U.S. Phase 3 AURORA trial to test 12-week efficacy plus long-term safety.
Full 52-week results from license partner Ascletis' open-label extension ASC40-304 were presented at EADV 2026 in Vienna, Sagimet said via GlobeNewswire in its September 30 announcement. Treatment success kept rising with longer use. The U.S. trial has not started yet.
Medical information disclaimer: This article is for general educational purposes only and does not provide medical advice, diagnosis, or treatment. Always consult a physician or other qualified health professional about symptoms, medications, tests, or treatment decisions.
Table of Contents
- What improved through 52 weeks?
- How is this pill different?
- Who was in the long-term data?
- What will AURORA test?
- What can you do while waiting?
What improved through 52 weeks?
Investigator's Global Assessment treatment success reached 56.7%-57% by one year. Mean total lesions fell about 71.8%-72% from parent-trial baseline. Mean inflammatory lesions fell about 76.9%-77% from the same baseline.
The pattern was progressive and sustained, not an early peak followed by fade. That matters for acne, where many treatments lose effect when irritation, missed doses, or flares interrupt use. Longer control without new safety signals makes daily use more practical to discuss.
How is this pill different?
Denifanstat is a first-in-class fatty acid synthase inhibitor taken once daily by mouth. It reduces facial sebum by blocking de novo lipogenesis in sebocytes. It also reduces inflammation by decreasing cytokine secretion.
Ascletis develops it as ASC40 in China, while Sagimet develops it elsewhere. Most acne care is topical or targets bacteria, hormones, or retinoid pathways. A sebum-focused oral approach would add a different option if later trials confirm benefit.
Who was in the long-term data?
The extension enrolled 240 patients from the 480-patient China parent trial ASC40-303. Of those, 116 had received denifanstat from the start and 124 switched from placebo.
All received denifanstat for up to 52 weeks total. Through 52 weeks, denifanstat was generally well tolerated with no adverse-event-related permanent discontinuations and no drug-related serious adverse events. The only treatment-related events above 5% were dry skin at 7.1% and dry eye at 5.9%.
What will AURORA test?
The planned U.S. AURORA trial will enroll about 800 patients aged 12 and older, including about 450 adolescents aged 12-17, Dermatology Times reported in its summary of the trial design. Patients will be randomized 2:1 to denifanstat 50 mg or placebo once daily for 12 weeks.
Three co-primary endpoints at week 12 are global-assessment success plus absolute change in inflammatory lesions and absolute change in noninflammatory lesions. That extension phase is designed to collect longer-term safety data. Short-term lesion counts alone do not prove durability. The added 40 weeks will show whether early gains persist with continued dosing.
- About 800 participants aged 12 and older
- About 450 adolescents aged 12-17 included
- 2:1 randomization to 50 mg denifanstat or placebo for 12 weeks
- About 530 completers may enter a 40-week open-label extension
What can you do while waiting?
The 52-week data come from an open-label extension in China with no concurrent placebo arm. Durability and U.S. generalizability remain unproven until the randomized, placebo-controlled AURORA trial, which has not compared denifanstat head-to-head against antibiotics. Readers should keep current treatment steady rather than pause care while awaiting trial results.
FDA issued a Study May Proceed letter with IND clearance on Aug. 13, 2026, Sagimet said via GlobeNewswire in its FDA clearance notice. Sagimet later said all sites and a contract research organization were secured, with screening expected in October 2026 for enrollment in the fourth quarter of 2026. Ask your dermatologist whether trial participation fits your age, acne severity, and current medications.