Quoin Pharmaceuticals Plans Q3 2026 QRX009 Trials in Pachyonychia Congenita, Gorlin Syndrome, Tuberous Sclerosis Complex
Quoin Pharmaceuticals will initiate Q3 2026 investigator-led QRX009 topical rapamycin trials in Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex led by Professor Edel O’Toole for PC. The company aims to file an IND for a fourth QRX009 indication and have four active clinical programs by year-end.
1. Clinical Trial Expansion
Quoin Pharmaceuticals is expanding its rare disease pipeline by launching investigator-led studies of QRX009 topical rapamycin lotion in Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex, targeting study initiations throughout 2026.
2. Investigator-Led Study Leadership
The inaugural Pachyonychia Congenita study will be led by Professor Edel O’Toole of Queen Mary University of London, leveraging Quoin’s proprietary 4%–5% rapamycin formulation to seek improved clinical outcomes over past trials.
3. Regulatory Filing Plans
The company is on track to submit an Investigational New Drug application to the FDA in Q3 2026 for an additional QRX009 indication, with the goal of having four active QRX009 clinical programs by the end of the year.
4. Strategic Partnerships and Pipeline Context
Quoin has established relationships with The PC Project and the Gorlin Syndrome Alliance, and is advancing a pivotal trial for QRX003 in Netherton Syndrome alongside plans for a Peeling Skin Syndrome IND in Q3 2026.