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Renalys Pharma Submits an IND Application for a Phase III Clinical Trial of sparsentan for IgA Nephropathy in Japan [Yahoo! Finance]

Travere Therapeutics, Inc. (TVTX) 
Company Research Source: Yahoo! Finance
Investigational New Drug (IND) Application for sparsentan to the Pharmaceuticals and Medical Devices Agency (PMDA) for a Phase III clinical trial in Japan The Phase III study is a multicenter, open-label, single arm study in Japanese patients with IgA nephropathy, and is planned to confirm the efficacy and safety of sparsentan in approximately 30 Japanese patients. First Patient In (FPI) is expected in the second half of 2024. Sparsentan was developed by Travere Therapeutics, Inc. ("Travere") and Renalys Pharma has an exclusive license for development and commercialization of sparsentan in Japan South Korea Taiwan , Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam. In 2023, Travere received FDA accelerated approval for sparsentan (U.S. brand name: FILSPARI®) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression*. In addition, Travere submitted a supplemental New D Show less Read more
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