Quoin Pharmaceuticals Announces FDA Fast Track Designation for QRX003 for the Treatment of Peeling Skin Syndrome
FDA Fast Track status for QRX003 in Peeling Skin Syndrome may accelerate development in a disease that currently has no approved treatment.
Rhea-AI Summary
Quoin Pharmaceuticals (QNRX) received FDA Fast Track Designation for its investigational topical lotion QRX003 to treat Peeling Skin Syndrome (PSS).
This is the first Fast Track Designation ever granted for a PSS therapy and the second indication for which QRX003 has Fast Track status, following Netherton Syndrome. The designation follows FDA clearance in July 2026 of the first Investigational New Drug application ever submitted for PSS, which Quoin filed on June 2, 2026. Quoin plans to start a Phase 2/3 study in 2H 2026 in the U.S. and Europe, enrolling up to 12 pediatric and adult patients treated twice daily over 48 weeks, with an interim review at 24 weeks. The IND was supported by an ongoing investigator-led pediatric study in a single subject showing skin improvements and better pruritus and quality-of-life measures with over 15 months of dosing and no reported adverse events. Quoin is targeting potential QRX003 approval for PSS in 2028.
Positive
- First-ever Fast Track for PSS granted to QRX003 by FDA
- Second Fast Track indication for QRX003, after Netherton Syndrome
- First IND for PSS submitted June 2, 2026 and cleared in July 2026
- Phase 2/3 PSS trial planned 2H 2026, up to 12 patients, 48-week dosing
- 15+ months single-patient dosing with no reported adverse events and recorded clinical improvements
- Multiple regulatory designations for QRX003 in Netherton Syndrome and PSS, including Orphan Drug, Rare Pediatric Disease and Fast Track
Negative
- None.
Key Figures
- Planned study phase
- Phase 2/3
- Peeling Skin Syndrome study
- Planned enrollment
- Up to 12 patients
- Pediatric and adult patients in the U.S. and Europe
- Study initiation
- 2H 2026
- Expected Phase 2/3 study start
- Dosing frequency
- Twice-daily
- Planned Phase 2/3 study
- Body surface area
- >80%
- Patients’ body surface area treated
- Treatment period
- 48 weeks
- Planned Phase 2/3 study
- Interim data review
- 24 weeks
- Planned Phase 2/3 study
- Approval target
- 2028
- Targeted QRX003 approval for Peeling Skin Syndrome
Previous Clinical trial Reports
-
FDA cleared QRX003’s first IND for PSS, enabling a planned Phase 2 study.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
fast track designation regulatory
investigational new drug regulatory
serine protease inhibitor medical
modified ichthyosis area severity index medical
investigator’s global assessment medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
– First-Ever Fast Track Designation Granted for a Peeling Skin Syndrome Therapy
– Second Fast Track Designation Granted to QRX003, in Addition to Netherton Syndrome
– Fast Track Designation Facilitates Development and Expedites Regulatory Review of Therapies Addressing Serious Conditions with Significant Unmet Medical Need
– Follows July 2026 FDA Clearance of the First-Ever IND Submitted for Peeling Skin Syndrome
– Phase 2/3 Study Expected to Initiate in 2H 2026, Enrolling up to 12 Pediatric and Adult Patients in the U.S. and Europe
– Peeling Skin Syndrome Currently Has No Approved Treatment
ASHBURN, Va., Sept. 22, 2026 (GLOBE NEWSWIRE) -- 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
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 (
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.
Forward-Looking Statements
The Company cautions that statements in this press release that are not descriptions of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances, such as "expect," "intend," "hope," "plan," "potential," "anticipate," "look forward," "believe," "may," and "will," among others. This press release contains forward-looking statements. All statements that reflect the Company’s expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to: Fast Track Designation facilitating development and expediting regulatory review of therapies addressing serious conditions with significant unmet medical need; plans to initiate a Phase 2/3 clinical study of QRX003 in Peeling Skin Syndrome in the second half of 2026; Fast Track status allowing Quoin to work closely with the FDA to advance the first company-sponsored clinical study in Peeling Skin Syndrome; the study expecting to enroll up to 12 pediatric and adult patients with Peeling Skin Syndrome in the United States and Europe; QRX003 expected to be applied twice-daily to greater than
For further information, contact:
Quoin Pharmaceuticals Ltd.
Michael Myers, Ph.D., CEO
mmyers@quoinpharma.com
Investor Relations
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
(646) 863-6341
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What advantages can FDA Fast Track Designation provide for QRX003?
The FDA’s Fast Track program is intended to facilitate development and expedite review of drugs that treat serious conditions and address unmet medical needs. A therapy with Fast Track Designation may benefit from more frequent FDA interactions, eligibility for rolling review of regulatory submissions, and potential qualification for Accelerated Approval and Priority Review if relevant criteria are met.
What are the key design features of the planned Phase 2/3 study of QRX003 in Peeling Skin Syndrome?
The planned Phase 2/3 study is expected to enroll up to 12 pediatric and adult PSS patients in the United States and Europe. QRX003 will be applied twice daily to more than 80% of each patient’s body surface area for 48 weeks, with an interim data review at 24 weeks.
What clinical observations supported the IND for QRX003 in Peeling Skin Syndrome?
The IND submission was supported by clinical observations from an ongoing investigator-led pediatric study in a single subject. The subject has shown improvements in objective severity endpoints, including the Modified Ichthyosis Area Severity Index, Investigator’s Global Assessment, pruritus, and a pediatric dermatology-specific quality-of-life measure (CDLQI). Treatment with QRX003 has continued for more than 15 months, and no adverse events have been reported.
What regulatory designations has QRX003 received across its target indications?
QRX003 is an investigational topical serine protease inhibitor lotion in late-stage development for Netherton Syndrome and other orphan skin diseases. For Netherton Syndrome, it has Orphan Drug, Rare Pediatric Disease, and Fast Track designations from the FDA, and Orphan Drug Designation in the European Union and Japan. For Peeling Skin Syndrome, it has Rare Pediatric Disease and Fast Track Designation from the FDA.
When does Quoin aim to secure potential approval of QRX003 for Peeling Skin Syndrome?
Quoin is targeting potential approval of QRX003 as a treatment for Peeling Skin Syndrome in 2028.