Quoin Pharmaceuticals Receives FDA Fast Track Designation for QRX003 in Peeling Skin Syndrome

Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) announced on September 22, 2026, that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational product candidate, QRX003, for the treatment of Peeling Skin Syndrome (PSS). The designation was included in the company’s Current Report on Form 8-K filed with the SEC.

QRX003 is a topical serine protease inhibitor lotion. The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious conditions with significant unmet medical need. Therapies granted this status may benefit from more frequent interactions with the FDA and eligibility for rolling review of regulatory submissions.

This is the second indication for which QRX003 has received Fast Track Designation. The FDA previously granted the designation for the treatment of Netherton Syndrome on March 11, 2026. The designation for PSS follows the FDA clearance of Quoin’s Investigational New Drug (IND) application for QRX003 in July 2026. Quoin submitted that IND on June 2, 2026, which was the first IND ever submitted to the FDA for Peeling Skin Syndrome.

The company stated that the Fast Track designation will allow it to work closely with the FDA to advance the first company-sponsored clinical study in Peeling Skin Syndrome. Quoin expects to initiate a Phase 2/3 clinical study of QRX003 in the second half of 2026. The study is expected to enroll up to 12 pediatric and adult patients in the United States and Europe. The treatment involves applying the lotion twice-daily to greater than 80% of the patients’ body surface area over a 48-week period, with an interim data review at 24 weeks.

According to the company, the IND submission was supported by clinical observations from an ongoing investigator-led pediatric study. The subject has achieved improvements in skin appearance, pruritus, and quality-of-life measures. Treatment has continued for more than 15 months with no adverse events reported.

Peeling Skin Syndrome is a rare autosomal recessive genodermatosis caused by loss-of-function variants in the corneodesmosin gene (CDSN). Patients with the condition suffer from excessive shedding of the superficial layers of the epidermis, resulting in severe pain and chronic pruritus. Currently, there is no approved treatment for PSS.