QRX003

July 9, 2026: Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) announced the FDA cleared its IND for QRX003 to treat Peeling Skin Syndrome (PSS), enabling initiation of a planned Phase 2 study in 2H 2026. Quoin said the FDA expressed no safety concerns regarding the proposed study design or dosing duration. The IND was submitted June 2, 2026 and cleared in July 2026, described as the first IND submitted to the FDA for PSS and enabling the first company-sponsored formal clinical study in the disease.

Phase 2 PSS study: expected to enroll 6–8 pediatric and adult patients in the U.S. and Europe; QRX003 will be applied twice daily to >80% body surface area for 52 weeks. The company stated it is targeting approval in 2028.

Other QRX003 updates: PSS is the second cleared IND indication for QRX003, in addition to Netherton Syndrome. Quoin cited an ongoing investigator-led pediatric study where a subject showed clinically meaningful improvements by 12 weeks on M-IASI, IGA, and CDLQI, with >15 months of dosing and no adverse events reported. Quoin expects to initiate a pivotal Phase 3 study in Netherton Syndrome in 2H 2026, with a potential NDA filing in 2027.