CEO of Sagimet Biosciences shares where denifanstat could fit in acne treatment | 2026 Fall Clinical Derm

Denifanstat, an investigational once-daily oral pill from Sagimet Biosciences, more than doubled the rate of clear or almost-clear skin compared with placebo in a phase 3 trial of patients with moderate to severe acne in China, 33.2% vs. 14.6% at 12 weeks. The data were presented in a poster at the 2026 Fall Clinical Dermatology Conference.

Denifanstat blocks fatty acid synthase (FASN), an enzyme skin cells use to make the fats that become sebum, or skin oil. This process sets it apart from antibiotics and isotretinoin, the main oral treatments most see as Accutane for acne today. In this interview with Managed Healthcare Executive, David Happel, CEO of Sagimet Biosciences, discussed where denifanstat could fit alongside those drugs if it's approved.

Happel described four main drivers of acne: sebum production, bacteria, inflammation and clogged pores. He said sebum is the most important because it fuels the other three, so blocking it can affect each of them. Denifanstat also has a separate anti-inflammatory effect, which, according to Happel, helps explain the drop in inflammatory lesions seen in the trial. Those lesions fell 63.5% with denifanstat vs. 43.2% with placebo at 12 weeks.

Happel said he expects denifanstat to largely replace or sharply reduce the use of oral antibiotics, which raises concerns about resistance and side effects when taken long-term.

“It should dramatically reduce, if not replace entirely, antibiotic usage. There is a mandate within the dermatology community to reduce the amount of antibiotics in the treatment of these patients,” Happel said.

He also sees denifanstat being used before patients reach isotretinoin. Isotretinoin can be very effective but is usually reserved for the most severe cystic and nodular forms of acne, he said, adding that treating acne earlier could reduce isotretinoin use as well.

Happel called denifanstat the first novel mechanism for an oral acne drug in 44 years, since isotretinoin was approved in 1982. He noted its safety and tolerability allow physicians to take a longer view of how they treat the condition. In the trial, dry eye occurred in 10.9% of denifanstat patients vs. 8% on placebo, and dry skin in 6.3% vs. 2.9%. All denifanstat-related side effects were mild or moderate.