Xyngaris Phase 3 results show it worked well as a once-weekly topical treatment for moderate-to-severe acne. The main trial, called STAR-1, hit all three primary goals with clear statistical proof compared to a placebo, and patients saw improvements starting at just four weeks.[1][2][3]
Xyngari, from Dermata Therapeutics, uses a special ingredient from freshwater sponges called Spongilla technology. In the STAR-1 trial, which wrapped up in early 2025, it proved safe with no serious side effects linked to the treatment.[1][2][3] This kind of success usually means a drug heads straight to FDA approval as a prescription medicine. But Dermata chose a different path.[1][2]
Instead of seeking prescription status, the company pulled its FDA application and shifted focus to over-the-counter products. This lets them sell Xyngari more easily without needing full drug approval, fitting it into FDA rules for OTC skin care.[1][2] They plan to launch it as a weekly acne kit that people can buy directly.[6]
The results got presented at a big dermatology meeting in Paris in September 2025, sharing more details on how fast and strong the effects were.[2] Dermata also raised money through private placements, like $4.1 million upfront in late 2025, to fund this OTC push into 2026.[4][6][7]
On top of acne, Xyngari is teaming up with another treatment in early trials for excessive underarm sweating.[2][3][5] These strong Phase 3 numbers give Dermata a solid base to build consumer skin products.
Sources
https://www.merlintrader.com/drma-dermata-therapeutics-inc/
https://www.stocktitan.net/news/DRMA/
https://stockanalysis.com/stocks/drma/
https://www.gurufocus.com/news/4086641/dermata-therapeutics-drma-announces-41-million-private-placement
https://www.investing.com/equities/dermata-therapeutics
https://www.stocktitan.net/news/DRMA/dermata-therapeutics-announces-closing-of-up-to-12-4-million-private-5h1ea16uo3gl.html
https://finviz.com/news/263890/dermata-therapeutics-announces-closing-of-up-to-124-million-private-placement-priced-at-the-market-under-nasdaq-rules
https://www.bioworld.com/content/phase3-data-2025
https://www.ajbell.co.uk/market-research/NASDAQ:DRMA
