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2 clusters · 3 sources · 12 days · First seen · Last updated

Denifanstat clinical trials for acne vulgaris

Overview

Clinical data from phase 3 open-label extension studies for denifanstat, an oral fatty acid synthase (FASN) inhibitor, indicate sustained efficacy in treating moderate to severe acne vulgaris over a 52-week period.

Presented at dermatological congresses in late 2026, the ASC40-304 trial results showed treatment success rates of approximately 57% to 58%. Specific metrics included a 72% reduction in total lesions and a 77% reduction in inflammatory lesions. The drug functions by inhibiting the enzyme responsible for sebum production and reducing de novo lipogenesis rather than using antibiotic or retinoid mechanisms.

The trials were conducted by Ascletis BioScience, a license partner of Sagimet Biosciences. Following the acceptance of a new drug application by China’s National Medical Products Administration in December 2025, the studies have reported a favorable long-term safety profile.

Entities

Ascletis BioScience · Sagimet Biosciences · European Academy of Dermatology and Venereology · National Medical Products Administration · Neal Bhatia

Timeline

  1. [HEALTH] 2 sources
    Denifanstat shows sustained acne improvement in Phase 3 extension

    Phase 3 extension data shows oral denifanstat sustains significant reductions in acne lesions and inflammation through 52 weeks of treatment for moderate to severe acne vulgaris.

  2. [HEALTH] 2 sources
    Denifanstat maintains acne control in 52-week study

    Phase 3 extension data presented at EADV 2026 shows denifanstat sustained acne control for 52 weeks with a favorable safety profile in patients with moderate to severe acne.

Sources

consultantlive.com · dermatologytimes.com · mdmag.com