Denifanstat Acne Trial Success
Sagimet Reports Strong 52-Week Acne Trial Results for Oral Drug Denifanstat
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Key Points
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The China extension followed a 12-week trial in which 116 participants had received denifanstat and 124 had received placebo; both groups then received denifanstat during the 40-week extension.
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Reported treatment-related side effects included dry skin in 7.1% of patients and dry eye in 5.9%.
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Ascletis said China’s National Medical Products Administration accepted denifanstat’s new drug application for moderate to severe acne in December 2025.
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Sagimet plans to submit an Investigational New Drug application by mid-2026, and the company’s U.S. Phase 3 plans are contingent on IND clearance.
Sagimet Biosciences reported strong long-term results for denifanstat, an oral acne drug tested in 240 Chinese patients over 52 weeks. About 57% achieved treatment success, while total acne lesions dropped roughly 72% and inflammatory lesions fell about 77%, Watchlist News reported. The company plans to begin screening for a U.S. Phase 3 trial called AURORA in October 2026, pending regulatory approval.
Denifanstat works by blocking an enzyme called fatty acid synthase. Dermatology Times noted the drug was generally well tolerated, with dry skin affecting 7.1% of patients and dry eye affecting 5.9%. No serious drug-related side effects or permanent discontinuations occurred during the study.
How the 52-Week Study Worked
The trial started with 240 patients split into groups. Prism Market View explained that 116 initially received denifanstat while 124 received a placebo for 12 weeks. Both groups then switched to denifanstat for a 40-week extension phase, creating long-term safety and effectiveness data.
China Already Approved, U.S. Timeline Remains Uncertain
China's regulators moved quickly on denifanstat. Yahoo Finance reported that China's National Medical Products Administration accepted the drug's new drug application for moderate to severe acne in December 2025. Sagimet must submit an Investigational New Drug application to the U.S. FDA by mid-2026 before it can launch U.S. trials.
The planned U.S. Phase 3 AURORA trial will enroll roughly 800 patients. Seeking Alpha noted this is the first controlled U.S. trial—the Chinese 52-week study was open-label, meaning both doctors and patients knew who received the drug, which is less rigorous than blinded trials required for FDA approval.
Stock Market Reaction Signals Investor Confidence
Yahoo Finance reported that Sagimet shares jumped 12% after the 52-week data announcement. The positive results on acne reduction and safety bolstered investor confidence that the company's U.S. Phase 3 plans are on track and denifanstat could become a viable new acne treatment option.
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