QRX003 Reaches Eight Significant Regulatory Designations as Quoin Adds EU Orphan Status in Peeling Skin Syndrome

Until this year, no company had ever filed an IND with the FDA for Peeling Skin Syndrome (PSS). Now the disease has a clinical trial on track to begin before year end, and significant regulatory designations on both sides of the Atlantic.

The latest comes from the European Medicines Agency (EMA), which has granted Orphan Drug Designation to QRX003, Quoin Pharmaceuticals’ (NASDAQ: QNRX) investigational topical serine protease inhibitor lotion, for the treatment of PSS. It is QRX003’s third designation in PSS in roughly five weeks, following FDA Rare Pediatric Disease Designation on September 8 and FDA Fast Track Designation on September 22. Each of these regulatory designations represent the first ever granted for a potential PSS therapy. Across both PSS and Netherton Syndrome, QRX003 has now accumulated an impressive eight regulatory designations on three continents.

What European Orphan Status Provides

The designation gives Quoin access to scientific advice on study protocols, fee reductions, and potentially EU grants. If the EMA approves QRX003 for PSS, Quoin would receive 10 years of market exclusivity in Europe with respect to similar medicines for the disease. The timing fits the clinical plan: Quoin’s upcoming Phase 2/3 study will enroll patients in both the United States and Europe.

“These eight important regulatory milestones reflect both the innovative nature of the product and the recognition of the unmet medical needs it is targeting,” said Dr. Michael Myers, CEO and Co-Founder of Quoin. “We are on track to initiate the first-ever formal clinical study for Peeling Skin Syndrome, a severe rare skin disease that has long been underserved.”

Inside the First Formal Trial in PSS

Quoin submitted the IND on June 2, 2026, and the FDA cleared it in July. The Phase 2/3 study will enroll up to 12 pediatric and adult patients, who will apply QRX003 twice daily to more than 80% of their body surface area over 48 weeks, with an interim data review at 24 weeks. Quoin is targeting approval for PSS in 2028.

The IND was supported by an ongoing investigator-led pediatric study in a single subject, who has shown significant clinical improvements across multiple endpoints including M-IASI (Modified Ichthyosis Area Severity Index), IGA (investigators Global Assessment), pruritus (itch), and CDLQI (Children’s Daily Quality of Life Index). After more than 15 months of continuous dosing with QRX003, no adverse events have been reported.

Netherton Topline Data Expected in 2027

The nearer-term catalyst sits in Netherton Syndrome, QRX003’s more advanced indication. Quoin expects to complete recruitment of 20 participants in its ongoing Phase 2/3 study by the end of 2026, with topline data expected in the second quarter of 2027.

A Disease with No Approved Treatment

Generalized inflammatory PSS is a rare genetic disease caused by loss-of-function variants in the corneodesmosin gene (CDSN), which cause the outer layers of the skin to shed excessively. Patients generally live with severe pain and chronic itch. There is currently no approved treatment.