Quoin gets FDA Fast Track for QRX003 in peeling skin syndrome

Quoin Pharmaceuticals Ltd. said on September 22, 2026 that the FDA granted Fast Track Designation to QRX003 for the treatment of Peeling Skin Syndrome (PSS). QRX003 is an investigational topical serine protease inhibitor lotion, and PSS is a rare genetic skin disease for which there is currently no approved treatment.¹

According to the company, no Fast Track Designation has previously been granted for a PSS therapy, and this marks the second indication for which QRX003 has received the designation.¹ The FDA had granted Fast Track Designation to QRX003 lotion (4%) for Netherton Syndrome on March 11, 2026.¹

The new designation follows FDA clearance in July 2026 of Quoin's IND application for QRX003 in Peeling Skin Syndrome, which the company submitted on June 2, 2026, marking the first IND ever filed with the agency for this disease.¹ Quoin said it expects to start a Phase 2/3 study of QRX003 in PSS during the second half of 2026.¹

The planned Phase 2/3 trial is designed to enroll up to 12 pediatric and adult patients with PSS across the United States and Europe, with QRX003 applied twice daily to more than 80% of body surface area over 48 weeks, including an interim look at the 24-week mark.¹ The company said it is aiming for potential approval in 2028, according to its release.

Supporting data came from an outside investigator's single-patient pediatric study. That patient showed improvement on measures including the Modified Ichthyosis Area Severity Index, Investigator's Global Assessment, pruritus scores and the CDLQI quality-of-life scale, with more than 15 months of continued dosing and no adverse events reported.¹

The FDA's Fast Track program is meant to speed development and review of drugs for serious conditions with unmet need, and can bring more frequent FDA interaction, rolling review eligibility, and potential access to Accelerated Approval and Priority Review if criteria are met.¹