Denifanstat is an oral medication developed by Sagimet Biosciences that blocks an enzyme called fatty acid synthase, or FASN. This enzyme helps make excess fats in the body, including in the skin.
Acne happens when skin pores get clogged with oil, dead skin cells, and bacteria. This leads to pimples, blackheads, and cysts, especially in moderate to severe cases. Too much oil, or sebum, from sebaceous glands fuels this problem. Denifanstat cuts sebum production and calms skin inflammation by stopping FASN from overworking.[1][2][3][6]
In simple terms, less sebum means fewer clogs and less irritation. Patients take it as a once-daily pill, which makes it easy compared to creams or washes.[3][5]
Early tests in a phase 2 trial showed it reduced acne lesions after 12 weeks in people with moderate to severe acne.[1][6] A phase 3 trial in China, run by partner Ascletis, went even better. It included 480 patients and hit all main goals. Denifanstat cleared skin twice as well as fake pills, with fewer pimples and inflammatory spots. It was safe, with no major side effects or dropouts.[4][5][8]
Doctors see it as a fresh option because it targets the root causes directly, unlike some older treatments that just fight bacteria on the surface.[2][5] Sagimet plans more studies, and it could soon reach patients worldwide.[3][5]
Sources
https://www.dermatologyadvisor.com/news/denifanstat-improves-lesion-count-moderate-severe-acne-vulgaris/
https://www.dermatologytimes.com/view/dermatology-times-2025-year-in-review-acne
https://www.globenewswire.com/news-release/2025/12/18/3207571/0/en/Sagimet-Biosciences-Announces-Positive-Results-from-the-Phase-1-PK-Clinical-Trial-of-Denifanstat-and-Resmetirom-Combination.html
https://uk.investing.com/news/company-news/sagimet-reports-positive-phase-1-results-for-mash-combination-therapy-93CH-4423559
https://stockanalysis.com/stocks/sgmt/
https://onlinelibrary.wiley.com/toc/14683083/2021/0/0
