Quoin Pharmaceuticals Earns FDA Fast Track, MHLW Orphan Designations, Targets 2027 NDA
QNRX•Quoin Pharmaceuticals secured Fast Track Designation from the FDA for QRX003 lotion (4%) and obtained Orphan Drug Designation plus Fast Track review qualification from Japan's MHLW for Netherton Syndrome. The company also filed for Breakthrough Medicine Designation in Saudi Arabia, expects Phase 3 recruitment by end-2026 and NDA filing in 2027.
1. Regulatory Milestones for QRX003
Quoin secured Fast Track Designation from the U.S. FDA for QRX003 lotion (4%) and filed for Breakthrough Medicine Designation with the Saudi FDA to accelerate review. Japan's MHLW confirmed QRX003 qualifies for Orphan Drug Designation and Fast Track review, while the U.S. Rare Pediatric Disease Priority Review Voucher program was extended to 2029.
2. Phase 3 Development and NDA Timeline
In a constructive Type C meeting, the FDA indicated that a single Phase 3 study with an alternative design may suffice for U.S. approval without traditional placebo control. Quoin remains on track to complete Phase 3 patient recruitment by end-2026 and potentially submit an NDA in 2027 as the first treatment for Netherton Syndrome.
3. QRX009 Topical Rapamycin Platform
Through key opinion leader and advocacy group engagement, Quoin is positioned to initiate investigator-led clinical studies of QRX009 in Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex later this year. The company plans to submit an IND for an additional QRX009 indication by Q3 2026.
