# What Is Denifanstat and When Will It Be Available
Denifanstat is a new type of medication that works by blocking an enzyme called fatty acid synthase, or FASN for short. This enzyme is responsible for producing fatty acids in the body, and blocking it appears to help reduce acne. The drug is considered “first-in-class,” meaning it is the first medication of its kind to work this way.
The medication comes as a once-daily oral pill, making it convenient for patients to take. Denifanstat was developed by two companies working together. Sagimet Biosciences, a company based in California, originally created the drug. They then licensed it to Ascletis Pharma, a Hong Kong-based pharmaceutical company, specifically for use in treating acne in China.
In clinical trials, denifanstat showed strong results for treating moderate-to-severe acne. During a Phase III clinical trial, the drug met all of its primary endpoints and key secondary endpoints when compared to a placebo. Patients taking denifanstat experienced significant improvements in their acne symptoms. The medication also demonstrated a favorable safety profile, with all treatment-related side effects being either mild or moderate in severity.
On December 10, 2025, China’s National Medical Products Administration accepted Ascletis’s New Drug Application for denifanstat. This acceptance means the regulatory pathway is moving forward in China. However, this does not mean the drug is immediately available to patients. The acceptance of the application is an important step, but additional regulatory processes typically follow before a medication becomes available for prescription.
Beyond acne treatment, denifanstat is also being studied for other medical conditions. Sagimet is developing the drug for a liver condition called metabolic dysfunction-associated steatohepatitis, or MASH. In a Phase 2b clinical trial called FASCINATE-2, denifanstat showed promise in improving liver fibrosis in certain MASH patients. This suggests the drug may have applications beyond dermatology.
The exact timeline for when denifanstat will be available to patients in China remains unclear based on current information. While the regulatory acceptance is a positive development, patients and healthcare providers will need to wait for further announcements from Ascletis regarding approval and market availability. For patients outside of China, availability would depend on whether Sagimet or other partners pursue regulatory approval in their respective regions.
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