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Denifanstat · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Denifanstat | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Denifanstat | DRUG | Oral, once daily |
| Placebo | OTHER | Oral, once daily |
Inclusion Criteria: 1. Must be willing and able to participate in the trial and provide written informed consent or assent 2. Aged ≥12 years on the date that written informed consent/ assent is provided 3. Moderate to severe acne vulgaris based on the following criteria at screening: 1. The EGS...
Denifanstat is an investigational small molecule being developed for the treatment of moderate to severe acne vulgaris. It is currently in Phase 3 clinical development and is not yet approved for any indication. The ongoing study enrolls participants aged 12 years and older with moderate to severe acne.
Denifanstat belongs to the -stat enzyme inhibitor class, meaning it works by inhibiting an enzyme target. This enzyme-inhibiting mechanism is the basis for its development as a small molecule therapeutic for acne vulgaris. The precise enzyme target and downstream pathway effects are characterized by its -stat inhibitor class designation.
Denifanstat is being developed by Sagimet Biosciences Inc., which trades under the ticker SGMT. The company is advancing the small molecule as a potential treatment for moderate to severe acne vulgaris through Phase 3 clinical development.
Denifanstat is in Phase 3 clinical development for moderate to severe acne vulgaris. It is an investigational therapy and has not been approved by the FDA for any indication. The Phase 3 program represents the final stage of clinical testing before a potential regulatory submission.
Denifanstat is being evaluated in one active Phase 3 trial, NCT07863193, titled a Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne. The trial is currently recruiting approximately 800 participants in the United States. It is randomized, double-blind, and placebo-controlled, enrolling participants aged 12 years and older.