drugset / Trial / NCT07863193

Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne

NCT07863193 ↗

Phase 3 Recruiting 800 enrolled Sagimet Biosciences Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of denifanstat compared with matching placebo in participants with moderate to severe acne vulgaris who are ≥12 years of age. After the 12-week treatment phase, a subset of approximately 530 participants will have the option to consent to an open-label extension phase for an additional 40 weeks of treatment.

Timeline

Start
2026-10
Primary completion
2027-08
Completion
2028-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Denifanstat Small molecule — Oral

Indications