Lesion count reduction with oral denifanstat in moderate-to-severe acne vulgaris

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Created On: 19/02/2026

This study investigated the efficiency, safety, and tolerability of denifanstat (fatty acid synthase inhibitor) in moderate-to-severe acne.

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Key take away

Denifanstat 50 mg once daily delivers significant acne lesion reduction with a favorable safety profile in moderate-to-severe acne vulgaris.

Background

This study investigated the efficiency, safety, and tolerability of denifanstat (fatty acid synthase inhibitor) in moderate-to-severe acne.

Method

In this randomized, placebo-controlled, phase 2 clinical trial, participants received oral denifanstat once daily after dinner at doses of 25 mg (n=45), 50 mg (n=44), 75 mg (n=45), or placebo (n=45) over 12 weeks. Efficacy outcomes included changes from baseline in overall lesion counts, inflammatory lesion numbers, and the proportion of volunteers achieving at least a two-grade improvement in the Investigator’s global assessment (IGA). Safety outcomes were determined based on the occurrence of adverse events.

Result

At week 12, denifanstat markedly reduced total acne lesion counts as opposed to placebo. The proportion of patients attaining a ≥2-grade improvement in IGA was not statistically significant between the groups (Table 1).

Denifanstat was generally well-tolerated across all doses. Treatment-emergent adverse events (TEAEs) were reported in 48.9% (25 mg), 47.7% (50 mg), 62.2% (75 mg), and 48.9% (placebo) of participants. Common mild-to-moderate side effects encompassed dry eye, dry skin, proteinuria, skin peeling, and conjunctivitis, with no serious drug-related TEAEs observed.

Conclusion

Denifanstat 50 mg administered once daily for 12 weeks demonstrated favorable tolerability and potential efficacy in minimizing total acne lesions, justifying extended clinical investigation.