ASHBURN, Virginia — Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to QRX003 for the treatment of Peeling Skin Syndrome (PSS). QRX003 is an investigational topical serine protease inhibitor lotion. Peeling Skin Syndrome is a rare genetic skin disease for which there is currently no approved treatment.
Key Facts
- Fast Track Designation applies to QRX003 for the treatment of Peeling Skin Syndrome.
- This is the first ever Fast Track Designation granted for a Peeling Skin Syndrome therapy.
- Peeling Skin Syndrome is the second indication for which QRX003 has received Fast Track Designation. The FDA granted Fast Track Designation to QRX003 lotion (4%) for the treatment of Netherton Syndrome on March 11, 2026.
- The designation follows FDA clearance in July 2026 of Quoin’s Investigational New Drug (IND) application for QRX003 in Peeling Skin Syndrome. Quoin submitted that IND on June 2, 2026, and it was the first IND ever submitted to the FDA for the disease.
- Quoin expects to initiate a Phase 2/3 clinical study of QRX003 in Peeling Skin Syndrome in the second half of 2026.
- The IND submission was supported by clinical observations from an ongoing investigator-led pediatric study in a single subject. Significant improvements in skin appearance along with positive changes in pruritus and a number of quality-of-life measures have been recorded. Treatment is ongoing and has continued for more than 15 months, with no adverse events reported.
- There is currently no approved treatment for Peeling Skin Syndrome.
“This is an important regulatory milestone for QRX003 and for a community that today has no approved treatment,” said Dr. Michael Myers, CEO and Co-Founder of Quoin Pharmaceuticals. “Quoin submitted the first IND ever filed with the FDA for Peeling Skin Syndrome, that IND was cleared in July, and QRX003 has now been granted Fast Track Designation for the disease. We expect to initiate our Phase 2/3 study in the second half of 2026, and we believe Fast Track status will allow us to work closely with the agency as we advance the first company-sponsored clinical study in this disease.”
Peeling Skin Syndrome Development Program
The planned Phase 2/3 study is expected to enroll up to 12 pediatric and adult patients with Peeling Skin Syndrome in the United States and Europe. In the study, QRX003 will be applied twice-daily to greater than 80% of patients’ body surface area (BSA) over a 48-week period, with an interim data review at 24 weeks. Quoin is targeting approval of QRX003 as a potential treatment for Peeling Skin Syndrome in 2028.
The IND submission was supported by clinical observations from an ongoing investigator-led pediatric study. The subject has achieved improvements across key objective severity endpoints, including the Modified Ichthyosis Area Severity Index (M-IASI), Investigator’s Global Assessment (IGA) as well as pruritus and a pediatric dermatology-specific quality-of-life measure (CDLQI). Treatment is ongoing, and after continued dosing with QRX003 for over 15 months, no adverse events have been reported.
About Fast Track Designation
The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. A therapy granted Fast Track Designation may benefit from more frequent interactions with the FDA, eligibility for rolling review of regulatory submissions, and potential qualification for Accelerated Approval and Priority Review, if relevant criteria are met.
About Peeling Skin Syndrome (PSS)
Generalized inflammatory peeling skin syndrome (PSS) is a rare autosomal recessive genodermatosis caused by loss-of-function disease-causing variants of the corneodesmosin gene (CDSN), resulting in excessive shedding of the superficial layers of the epidermis. Patients generally suffer from a variety of conditions including severe pain and chronic pruritus (itch). There is currently no approved treatment for PSS.
About QRX003
QRX003 is an investigational topical serine protease inhibitor lotion in late-stage development for Netherton Syndrome and other orphan skin diseases. QRX003 has been granted Orphan Drug, Rare Pediatric Disease, and Fast Track designations by the U.S. Food and Drug Administration, and Orphan Drug Designation in the European Union and Japan for Netherton Syndrome. QRX003 has also been granted Rare Pediatric Disease and Fast Track Designation by the FDA for Peeling Skin Syndrome. QRX003 lotion (4%) is currently being evaluated in Phase 2/3 whole-body clinical trials in patients with Netherton Syndrome. Quoin expects to initiate a Phase 2/3 clinical study of QRX003 in Peeling Skin Syndrome in the second half of 2026.
About Quoin Pharmaceuticals Ltd.
Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities, and care teams. Quoin’s innovative pipeline is focused on two key platform products, QRX003 and QRX009, that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibromas and others. For more information, visit: www.quoinpharma.com or LinkedIn for updates.
For further information, contact:
Quoin Pharmaceuticals Ltd.
Michael Myers, Ph.D., CEO
[email protected]
Investor Relations
PCG Advisory
Jeff Ramson
[email protected]
(646) 863-6341