FDA Fast-Track Approval for Quoin’s Peeling Skin Therapy

Quoin Pharmaceuticals Ltd., based in Ashburn, Virginia, has received fast-track designation from the U.S. Food and Drug Administration (FDA) for QRX003, an investigational topical serine protease inhibitor lotion designed to treat Peeling Skin Syndrome and Netherton Syndrome. This marks the first time the FDA has granted fast-track status to a treatment for Peeling Skin Syndrome, a rare genetic skin condition lacking approved therapies. The designation follows an earlier fast-track approval for QRX003’s use in Netherton Syndrome, granted in March 2026, making it the second fast-track designation for the compound overall. The company submitted an Investigational New Drug (IND) application for Peeling Skin Syndrome in June 2026, with clearance expected in July 2026. Clinical trials are planned for the second half of 2026, targeting up to 12 pediatric and adult patients in the U.S. and Europe. QRX003 is intended for twice-daily application to more than 80% of a patient’s body surface area. The IND submission was supported by data from an ongoing investigator-led pediatric study, where a single subject received continuous treatment for over 15 months with no adverse events reported. The company anticipates initiating Phase 2/3 clinical studies with interim data reviewed at 24 weeks, with a potential approval timeline extending to 2028.