Home / Health / Peeling Skin Syndrome Hope: FDA Greenlights New Trial
Peeling Skin Syndrome Hope: FDA Greenlights New Trial
10 Jul
Summary
- FDA cleared Quoin Pharmaceuticals' IND application for QRX003.
- Phase II trial for Peeling Skin Syndrome treatment will start soon.
- QRX003 targets a rare genetic disorder causing excessive skin shedding.
Quoin Pharmaceuticals has secured FDA clearance for its investigational new drug, QRX003, to initiate a crucial Phase II clinical trial targeting Peeling Skin Syndrome (PSS). This rare genetic disorder significantly impacts patients with excessive skin shedding, pain, and persistent itch, leaving them with no approved treatment options.
The clinical trial is anticipated to commence in the latter half of 2026. It will involve a cohort of six to eight pediatric and adult patients across the United States and Europe who are living with PSS. The study protocol includes twice-daily application of QRX003 to over 80% of the body surface area for a duration of 52 weeks.
Quoin Pharmaceuticals is strategically targeting a 2028 approval for QRX003 for PSS, marking a significant step in addressing an overlooked disease. The drug, a topical serine protease inhibitor lotion, is also under evaluation for Netherton Syndrome, with preliminary studies showing clinically meaningful improvements in patients without reported adverse events, fueling optimism for future therapeutic success.
