Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) announced that the U.S. Food and Drug Administration has conditionally approved QYLEKI as the proposed brand name for QRX003, its investigational topical treatment for Netherton Syndrome, a rare inherited skin disorder with no currently approved therapies.

The conditional approval of the brand name, pronounced "Key-Lek-ee," was developed in accordance with FDA guidance on proprietary names. Final approval of the QYLEKI brand name will be contingent on FDA marketing approval of QRX003. A request for proprietary name review and final approval will be included in a future New Drug Application.

QRX003 holds Orphan Drug Designation in the United States, the European Union, and Japan, and has received Fast Track and Rare Pediatric Disease Designations from the FDA. The drug is currently being evaluated as a 4% lotion in Phase 2 whole-body clinical trials.

According to the company, a pivotal Phase 3 study is expected to begin in the second half of 2026, with a potential NDA filing anticipated in 2027.

"The designation of a brand name for the first potentially approved treatment for Netherton Syndrome represents another important step for Quoin, our commercial partners and most importantly, the Netherton community as a whole," said Dr. Michael Myers, Chief Executive Officer and Co-Founder of Quoin Pharmaceuticals.

Netherton Syndrome is caused by mutations in the SPINK5 gene, resulting in severe skin barrier dysfunction, chronic inflammation, and increased risk of infections and allergic complications. Current treatment options are limited to supportive care and off-label therapies.