Sagimet Starts Phase 3 Acne Trial Targeting About 800 Patients
Key Facts
Sagimet Biosciences announced in a statement dated October 22, 2026, that the first patient had been dosed in its U.S. Phase 3 AURORA study testing denifanstat for moderate to severe acne. The study aims to enroll about 800 patients in the United States, aged 12 and older, as part of the treatment's development program. This group is expected to include 450 adolescents aged 12 to 17, according to the study design announced by the company. Dosing followed Sagimet's announcement in August that the U.S. Food and Drug Administration had cleared its investigational new drug application. The company said the agency had also issued a letter allowing the study to proceed before the program moved to dosing participants.
According to Sagimet, participants will be randomized in a 2:1 ratio to receive either 50 mg of denifanstat or a placebo. The treatment or placebo will be administered once daily for 12 weeks during the double-blind period. The primary efficacy endpoints include measuring the absolute change in inflammatory skin lesion counts from baseline. They also include measuring the absolute change in non-inflammatory lesion counts against the same baseline. Following the double-blind period, the study design includes a 40-week open-label extension to assess long-term safety in patients eligible to participate.
Sagimet estimates that moderate to severe acne affects about 10 million people annually in the United States, the patient population targeted by the treatment program. The company says the drug works by inhibiting fatty acid synthase to target key underlying causes of the disease. Effects it attributes to this mechanism include reducing new fat synthesis and sebum production, as well as inflammation. Alongside the U.S. program, Ascletis, Sagimet's licensed partner in China, submitted an application to register the treatment with China's National Medical Products Administration. Sagimet announced the application's acceptance in December 2025.
In results from the Chinese open-label extension, Sagimet reported an investigator-assessed treatment success rate of about 57% at the end of the extension. It said total lesion counts fell by about 72% from the original study's baseline, while inflammatory lesions declined by about 77%. On safety during the open-label extension, the rate of treatment-related dry skin was 7.1%, according to results announced by the company. The rate of treatment-related dry eye was 5.9% over the same period. In the Chinese comparative study, Sagimet said in a filing with the U.S. Securities and Exchange Commission that no serious events related to denifanstat were recorded.
The study's launch follows the closing of a Sagimet offering in October 2026, which generated gross proceeds of approximately $115.0 million before commissions and expenses. The company plans to use the offering proceeds, alongside existing resources, to support the pivotal denifanstat trial and pre-launch activities, as well as other development programs and operating expenses. The company previously reported cash, cash equivalents and marketable securities of $257.6 million as of June 30, 2026. In its strategic update, Chief Financial Officer Thierry Chauche said: "We are prioritizing dermatology programs in our capital allocation." He added that the company is seeking non-dilutive financing for its metabolic dysfunction-associated steatohepatitis treatment program.
In earlier coverage of the acne treatment data, Investing reported on September 30, 2026, that Oppenheimer had raised its price target for Sagimet shares to $38. The firm's previous price target was $33 per share. Oppenheimer maintained its "Outperform" rating, according to the same report. The next milestone Sagimet has set for the U.S. study is the release of topline results in the second half of 2027. Chief Executive David Happel said the results were "expected in the second half of 2027".