Regulatory2026-07-31

QRX003

Quoin Pharmaceuticals Ltd.QNRX
Indication
Peeling Skin Syndrome (PSS)
Stage
phase2
Event
Regulatory Decision
Details

June 2, 2026: Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) announced it has submitted an Investigational New Drug (IND) application to the U.S. FDA for QRX003 to treat Peeling Skin Syndrome (PSS), described as having no approved treatment. Pending FDA review, the company expects to initiate a Phase 2 clinical study in 2H 2026, planning to enroll 6–8 pediatric and adult PSS patients across the U.S. and Europe.

The IND is supported by clinical observations from an ongoing investigator-led pediatric PSS study: the initial subject has received QRX003 for more than 15 months, with reported significant improvements in skin, sleep patterns, and overall quality of life, and no adverse events reported. Quoin noted this is the second indication for QRX003 (in addition to Netherton Syndrome) and said both its QRX003 and QRX009 topical rapamycin platforms are targeted to be in clinical testing in the second half of this year.