Sagimet Biosciences Announces First Patient Dosed in AURORA Phase 3 U.S. Clinical Trial of Denifanstat for Moderate to Severe Acne
Sagimet Biosciences dosed the first patient in AURORA, its pivotal U.S. Phase 3 trial of once-daily oral FASN inhibitor denifanstat in moderate to severe acne. The trial plans to enroll about 800 U.S. patients aged 12 and older (including 450 adolescents), with topline results expected in the second half of 2027 to support a potential NDA.
Key figures
- Drug Name
- denifanstat (ASC40)
- Phase Of Trial
- Phase 3
- Dose
- 50 mg once daily
- Trial name
- AURORA
- Topline timing
- second half of 2027
- Treatment period
- 12-week double-blind, 40-week open-label extension
- Planned enrollment
- approximately 800 U.S. patients (450 adolescents aged 12-17)
- Us patient population
- approximately 10 million with moderate to severe acne
AI analysis
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