What Makes Denifanstat Different From Hormonal Therapy
Denifanstat is a new oral drug that blocks an enzyme called fatty acid synthase, which helps control excess fat production in the body. Hormonal therapy, on the other hand, works by changing hormone levels to treat conditions driven by those hormones.
Denifanstat stands out because it targets the root cause of fat buildup without messing with hormones at all. For example, in treating moderate to severe acne, it reduces sebum, the oily substance on skin that clogs pores and causes breakouts. A phase 3 trial in China with 480 patients showed it doubled treatment success rates compared to placebo by cutting sebum and inflammation directly.[2][4] This makes it a fresh option for acne sufferers who want to avoid hormone-related side effects like mood swings, weight gain, or irregular periods.
Hormonal therapies, such as birth control pills or spironolactone, often balance hormones like estrogen, progesterone, or androgens to ease acne or other issues. They can work well but come with risks tied to hormone shifts, and not everyone can use them due to health reasons like pregnancy plans or blood clot history.
In liver disease like MASH, or metabolic dysfunction-associated steatohepatitis, denifanstat shows promise by tackling fat in the liver. It improved fibrosis in a phase 2b trial for patients with cirrhosis, and early tests combining it with resmetirom, a non-hormonal liver drug, looked safe and effective.[2][3] Hormonal therapy has no real role here, as MASH stems from fat metabolism, not hormone imbalance.
For skin conditions beyond acne, denifanstat offers a targeted, once-daily pill that skips the body-wide hormone effects. Experts see it as a safer path for long-term use, especially since trials report good tolerability with few serious issues.[2][4]
Denifanstat’s enzyme-blocking action provides a non-hormonal alternative that hits fat production head-on, opening doors for acne, liver health, and possibly more without the hormone baggage.
Sources
https://sabcs.org/events/2025/poster-session-5/
https://www.investing.com/news/company-news/sagimet-reports-positive-phase-1-results-for-mash-combination-therapy-93CH-4414723
https://www.quiverquant.com/news/Sagimet+Biosciences+Enters+License+Agreement+with+TAPI+for+Innovative+Forms+of+Resmetirom+in+Fixed-Dose+Combination+Development
https://www.dermatologytimes.com/view/dermatology-times-2025-year-in-review-acne
