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Renalys Pharma Submits an IND Application for a Phase III Clinical Trial of sparsentan for IgA Nephropathy in Japan | |||
By: PR Newswire Association LLC. - 08 Apr 2024 | Back to overview list |
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TOKYO, April 7, 2024 /PRNewswire/ -- Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; "Renalys Pharma") announced that it has submitted an 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 Drug Application to FDA in March 2024, for conversion of the existing U.S. accelerated approval to full approval based on 2-year confirmatory results from the Phase III PROTECT Study, the only head-to-head study in IgA nephropathy versus an active comparator. In the PROTECT Study, FILSPARI® demonstrated a significant reduction in proteinuria, preservation of kidney function and a well-tolerated safety profile compared with active control irbesartan. Renalys Pharma is committed to advancing its business to contribute to improving the lives of patients in Japan and Asia through the development of innovative therapies that can improve the management of kidney disease, first and foremost by delivering sparsentan as soon as possible.
About IgA Nephropathy About Renalys Pharma, Inc. Company Name: Renalys Pharma, Inc. [Disclaimer] View original content:https://www.prnewswire.com/news-releases/renalys-pharma-submits-an-ind-application-for-a-phase-iii-clinical-trial-of-sparsentan-for-iga-nephropathy-in-japan-302109189.html SOURCE Renalys Pharma, Inc. |
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