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NicOx is a product-driven biopharmaceutical company dedicated to the development and future commercialization of investigational drugs for unmet medical needs.
NicOx is applying its proprietary nitric oxide-donating technology to develop an internal portfolio of New Chemical Entities (NCEs) in the therapeutic areas of inflammatory and cardio-metabolic disease.
NicOx’s lead investigational compound is naproxcinod, an NCE and a first-in-class CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory drug candidate for the relief of the signs and symptoms of osteoarthritis.
NicOx submitted a New Drug Application (NDA) for naproxcinod to the US Food and Drug Administration (FDA) in September 2009 and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) in December 2009, following the successful completion of three pivotal phase 3 studies.
The NDA for naproxcinod was accepted for filing by the FDA in November 2009 and the FDA has set a target date of July 24, 2010, for the completion of its review. The MAA was validated by the EMEA in January 2010.
In addition to naproxcinod, NicOx’s pipeline includes several nitric oxide-donating NCEs, which are in development internally and with partners, including Merck & Co., Inc., for the treatment of widespread eye diseases, cardiometabolic diseases, hypertension and dermatological disease.
NicOx S.A. is headquartered in France and is listed on Euronext Paris.
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