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Sagimet advances Phase 3 acne trial for denifanstat
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Sagimet advances Phase 3 acne trial for denifanstat

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  • Sagimet Biosciences (NASDAQ:SGMT) advanced preparations for its AURORA Phase 3 trial of denifanstat in moderate to severe acne.
  • The company completed site identification and selected a clinical research organization, with screening planned for October 2026.
  • The trial is expected to enroll about 800 U.S. patients and support a potential NDA submission after the 12-week phase.

Sagimet Biosciences (NASDAQ:SGMT) reported progress on its AURORA U.S. Phase 3 clinical trial evaluating denifanstat, a FASN inhibitor being developed for moderate to severe acne.

The company completed identification of clinical trial sites and retained a contract research organization, with patient screening expected to begin in October 2026 and first patient enrollment planned for the fourth quarter of 2026.

The AURORA trial is designed to enroll approximately 800 U.S. patients, including about 450 adolescents, and will include a 12-week randomized, double-blind treatment period with co-primary endpoints.

Following the initial 12-week phase, the study will continue with a 40-week open-label extension to evaluate long-term safety, while Sagimet stated it anticipates submitting a New Drug Application after completion of the 12-week period.

The company is developing denifanstat as a potential treatment targeting fatty acid synthase (FASN), an enzyme involved in lipid production pathways.

Sagimet Biosciences is focused on developing therapies for metabolic and inflammatory diseases, with denifanstat as its lead clinical-stage program.

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