FDA clears Sagimet’s acne drug denifanstat for Phase 3 trial
Regulatory clearance paves the way for late-stage testing of the oral FASN inhibitor as a potential acne treatment.
The U.S. Food and Drug Administration has cleared Sagimet Biosciences to proceed with a Phase 3 clinical trial for denifanstat, an oral fatty acid synthase inhibitor targeting moderate to severe acne.
The clearance follows the completion of a pre-investigational new drug meeting with the FDA, which provided guidance on the trial design and endpoints. Sagimet plans to initiate the Phase 3 program in the second half of 2024, according to a company statement.
Denifanstat is designed to reduce sebum production by inhibiting FASN, an enzyme involved in lipid synthesis. Preclinical and early clinical data have shown the drug’s potential to decrease inflammatory and non-inflammatory acne lesions.
The Phase 3 trial will evaluate the safety and efficacy of denifanstat compared to a placebo in patients aged 12 and older. Primary endpoints include changes in inflammatory lesion counts and Investigator’s Global Assessment scores.
Sagimet, a clinical-stage biopharmaceutical company, is developing denifanstat as a first-in-class treatment for acne and other dermatological conditions. The company has not disclosed financial terms or partnership agreements related to the program.
If successful, denifanstat could address a significant unmet need in acne treatment, where current therapies often carry side effects such as antibiotic resistance or systemic toxicity.
Helena covers corporate news for listed and private companies across Europe, from strategy shifts to leadership changes, with an eye for what a story signals about the broader market.
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