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Sagimet Biosciences Advances AURORA U.S. Phase 3 Trial of Denifanstat in Acne Toward Patient Enrollment in Q4 2026

SGMT
  • Sagimet Biosciences has identified all clinical trial sites & retained a CRO for the AURORA Phase 3 trial.
  • Patient screening is expected to begin in October 2026, with the first patient enrollment following shortly after.
  • The AURORA trial aims to enroll approximately 800 U.S. patients aged 12 and older, including about 450 adolescents.
  • The trial is a randomized, double-blind, placebo-controlled study where patients will receive denifanstat 50 mg or placebo once daily for 12 weeks.
  • Three co-primary endpoints will be assessed at week 12: global assessment scores, inflammatory lesion count changes, & non-inflammatory lesion count changes.
  • A 40-week open-label extension will evaluate long-term safety after the 12-week double-blind period.
  • Sagimet anticipates submitting a New Drug Application (NDA) upon completion of the 12-week study phase.
  • Denifanstat is an oral, once-daily FASN inhibitor; if approved, it would be the first innovative oral acne treatment in over 40 years.
  • Prior trials by license partner Ascletis BioScience in China showed denifanstat met all primary endpoints & demonstrated long-term safety.
  • Sagimet holds development rights for denifanstat outside China, while Ascletis develops it as ASC40 in China.