FOSTER CITY, Calif. — August 25, 2026
Sagimet Biosciences announced that its AURORA Phase 3 clinical trial of denifanstat for the treatment of moderate to severe acne is on track to begin patient enrollment in Q4 2026. The company has identified all clinical trial sites and retained a contract research organization (CRO), positioning the program for patient screening in October 2026 and enrollment of the first patient shortly thereafter. The development milestone moves denifanstat closer to a pivotal evaluation in a large patient population seeking additional treatment options for moderate to severe acne.
AURORA Trial Moves Toward Patient Screening
The AURORA Phase 3 study is planned as a multicenter, randomized, double-blind and placebo-controlled clinical trial evaluating denifanstat in approximately 800 U.S. patients aged 12 years and older, including about 450 adolescents aged 12 to 17 years. Patients will be randomized in a 2:1 ratio to receive either denifanstat 50 mg or placebo once daily for 12 weeks. Sagimet expects the trial to enroll participants over approximately six months, with the company preparing to initiate screening in October. The trial design includes three co-primary efficacy endpoints assessed at Week 12, covering global treatment success, inflammatory skin lesion reduction and non-inflammatory skin lesion reduction. Patients completing the randomized treatment period will have the opportunity to enter a 40-week open-label extension designed to generate longer-term safety information.
Denifanstat Targets FASN in Moderate to Severe Acne
Denifanstat is an oral, once-daily fatty acid synthase (FASN) inhibitor designed to target dysfunctional metabolic pathways associated with acne. FASN plays a role in lipid synthesis and represents a therapeutic target implicated in diseases involving abnormal fatty acid metabolism. Sagimet is developing denifanstat outside China, while its licensing partner Ascletis BioScience is developing the therapy as ASC40 in China. Previous clinical development by Ascletis provides an important foundation for the global program. In China, denifanstat reportedly met its primary and secondary endpoints in a 12-week randomized Phase 3 study in moderate to severe acne vulgaris, while longer-term follow-up showed continued improvements across measured efficacy endpoints through 52 weeks. The U.S. AURORA study will now provide pivotal data from a new patient population and is designed to establish the efficacy and safety profile required for potential regulatory submission.
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Sagimet Targets New Oral Acne Treatment Opportunity
The AURORA program addresses a substantial treatment market, with approximately 50 million people in the United States affected by acne annually and around 10 million estimated to have moderate to severe disease. Acne is particularly prevalent among adolescents and young adults, with approximately 85% of people between 12 and 24 years of age affected. Sagimet believes denifanstat could offer a differentiated treatment option through its once-daily oral administration and FASN-targeted mechanism. If the pivotal study produces positive results, the company anticipates submitting a New Drug Application (NDA) after completion of the 12-week randomized treatment phase. The immediate development milestones are patient screening beginning in October 2026, first-patient enrollment shortly afterward and progression of the approximately 800-patient AURORA study toward its Week 12 efficacy assessment.
Source:Sagimet Biosciences,press relese
