Quoin Receives FDA Conditional Approval for QYLEKI Brand Name for Netherton Syndrome Therapy
Wednesday, June 24, 2026
Quoin Pharmaceuticals has received conditional approval from the US Food and Drug Administration (FDA) for QYLEKI™ as the proposed brand name of QRX003, its investigational treatment for Netherton Syndrome.
The FDA’s acceptance of the proposed name marks an important regulatory milestone as Quoin continues the development of QRX003, which is being positioned as a potential first approved treatment for the rare genetic disorder. A request for final proprietary name approval will be submitted as part of a future New Drug Application (NDA) for QRX003.
QRX003 has already received Orphan Drug Designation in the United States, the European Union and Japan. The FDA has also granted the therapy Fast Track and Rare Pediatric Disease designations, supporting its development for patients with significant unmet medical needs.
Quoin expects to begin its pivotal Phase III clinical study during the second half of 2026, with a potential NDA submission planned for 2027.
The proposed brand name, QYLEKI, was developed in accordance with FDA guidelines for proprietary drug names. Final approval of the name will depend on the FDA’s marketing approval of QRX003.
The latest regulatory development follows recent progress in the company’s paediatric compassionate use programme and reflects ongoing efforts to advance the therapy towards commercialisation. If approved, QRX003 could become the first authorised treatment for patients with Netherton Syndrome, a rare inherited skin disorder for which no approved therapies currently exist.
Source: globenewswire.com
