Acne affects millions of people around the world, causing painful pimples, blackheads, and cysts on the face, back, and chest. For decades, treatments like topical creams, oral antibiotics, and isotretinoin have been the main options, but no major new drugs have broken through until very recently. This stall in progress comes from a mix of tough biology, safety worries, and business hurdles.
Acne starts when hair follicles get clogged with oil, dead skin, and bacteria like Cutibacterium acnes. Early drugs targeted bacteria with antibiotics such as tetracycline or minocycline. These worked at first but lost power over time as bacteria built resistance. Doctors hesitated to create stronger versions because long-term antibiotic use can upset the skin’s natural balance of microbes, leading to more problems like yeast infections or resistant superbugs. Recent studies on low-dose minocycline, now sold as Emrosi for rosacea, show it avoids big changes to skin, gut, or vaginal bacteria, but scaling this to acne has been slow due to similar fears.
The biology of acne is tricky too. It involves not just germs but also raging hormones, overactive oil glands, and inflammation deep in the skin. Isotretinoin, a powerful pill from the 1980s, shrinks oil glands and clears severe cases, but it carries risks like birth defects, dry skin, and mood changes. Regulators demand proof that new drugs beat these without worse side effects, which means long, costly trials. Companies often pull back because acne, while common, is not life-threatening, so investors prefer diseases with bigger payouts.
Pharma firms focused on antibiotics early on, inspired by successes like penicillin in the 1940s. But after waves of resistance hit, research shifted away. Natural remedies and devices, like bentonite masks or cold plasma treatments, popped up for mild cases, but they lack the punch for moderate to severe acne and do not count as true drug advances. Gene-editing tools like CRISPR are now in early trials for topical acne use, hinting at future breakthroughs, yet they face huge safety tests.
Money plays a big role. Developing a skin drug costs hundreds of millions and takes 10 to 15 years. With cheap generics flooding the market, profits look slim unless a drug works faster or safer. Patent cliffs on old standbys left gaps, but firms hesitated to fill them without clear paths to approval.
Signs of change are emerging. In December 2025, China’s regulators accepted a new drug application for denifanstat, a daily pill that blocks fatty acid synthase, an enzyme fueling oil and inflammation. Its phase 3 trial hit all goals for moderate to severe acne with good safety. This FASN inhibitor, licensed from Sagimet to Ascletis for China, shows how targeting root causes like excess fat production can sidestep antibiotic pitfalls. A backup drug, TVB-3567, is in early human tests for acne too. These moves suggest the stall is ending as science catches up to acne’s complexity.
Sources
https://www.stocktitan.net/news/SGMT/sagimet-s-license-partner-ascletis-announced-acceptance-of-new-drug-my9wyvmm6620.html
https://en.wikipedia.org/wiki/Antibiotic
https://investingnews.com/journey-medical-corporation-announces-publication-of-clinical-trial-results-assessing-the-impact-of-emrosi-on-microbial-flora-of-healthy-adults-in-the-journal-of-drugs-in-dermatology/
https://pmc.ncbi.nlm.nih.gov/articles/PMC12679517/
https://www.sanofiventures.com/news
