ASHBURN, Va. — January 27, 2026 — Leads & Copy — Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) has received confirmation from the Japanese Ministry of Health, Labour and Welfare (MHLW) that its lead product candidate, QRX003, qualifies for both Orphan Drug Designation (ODD) and Fast Track regulatory review status.
Quoin is planning to establish a Japanese subsidiary to facilitate the self-commercialization of QRX003 in Japan, if approved.
The company previously received ODD from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2025.
Quoin submitted the ODD application for QRX003, intended for the treatment of Netherton Syndrome, following a meeting with the MHLW. If granted, QRX003 will have ODD status in the US, EU and Japan.
The MHLW’s Orphan Drug Designation program provides orphan status to therapies for rare diseases affecting fewer than 50,000 people in Japan. The designation includes benefits such as R&D subsidies, tax credits for qualified clinical testing, reduction of MHLW application fees, priority review and ten years of market exclusivity, if approved.
QRX003 is on track to potentially become the first approved treatment for Netherton Syndrome.
According to Dr. Michael Myers, CEO of Quoin Pharmaceuticals, the company is optimistic that QRX003 will be granted ODD status in Japan. Myers also stated that Quoin is moving forward with plans to establish its own commercial infrastructure in Japan, one of three core territories for QRX003 and other pipeline products. The company is committed to completing the clinical development of QRX003.
QRX003 lotion (4%) is being evaluated in two late-stage whole body pivotal clinical trials for Netherton Syndrome. Enrollment in both pivotal studies is expected to be completed in the first half of 2026, with top-line data anticipated in the second half of 2026. NDA submission is planned later in the year or early 2027. In 2025, QRX003 was granted Orphan Drug Designation by the FDA and EMA.
Quoin Pharmaceuticals Ltd. is focused on developing and commercializing therapeutic products that treat rare and orphan diseases. Quoin’s pipeline includes products in development that have the potential to target a number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Microcystic Lymphatic Malformations, Venous Malformations, and Angiofibroma.
Source: Quoin Pharmaceuticals Ltd.
