QRX003 is an investigational topical broad-spectrum serine protease inhibitor lotion developed by Quoin for Netherton syndrome and additional rare dermatologic indications. It is designed to compensate for missing LEKTI function and normalize kallikrein activity to improve skin barrier integrity. As of March 2026, the product was in two late-stage whole-body clinical trials and had FDA Fast Track designation.
Quoin Pharmaceuticals has secured Orphan Drug Designations for QRX003 in the U.S. and Europe for Netherton Syndrome, while advancing regulatory pathways in Japan and Saudi Arabia. The company reported clinical progress including expansion of pediatric studies and potential for a Priority Review Voucher worth up to $200 million.
The FDA has granted fast track designation to QRX003 for Netherton Syndrome and IBI3003 for relapsed or refractory multiple myeloma, while also accepting regulatory applications for other therapies addressing serious conditions with unmet medical needs.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07538583 |
Phase 2/3 Clinical Study of QRX003 Lotion in Subjects With Netherton Syndrome |
RECRUITING | PHASE2/PHASE3 |
