Renalys Pharma Reaches Japan PMDA Agreement on Phase III Clinical Trials of Sparsentan for Focal Segmental Glomerulosclerosis (FSGS) and Alport Syndrome (AS)

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Renalys Pharma Reaches Japan PMDA Agreement on Phase III Clinical Trials of Sparsentan for Focal Segmental Glomerulosclerosis (FSGS) and Alport Syndrome (AS)

PR Newswire

TOKYO, Oct. 17, 2025 /PRNewswire/ -- Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; "Renalys") today announced that it has reached an agreement with the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan regarding development plans for two Phase III clinical trials of sparsentan in Japan (development code: RE-021) — one investigating the use of sparsentan in focal segmental glomerulosclerosis (FSGS) and the other in Alport syndrome (AS) in Japan.

Both studies are planned as multicenter, open-label, non-controlled Phase III clinical trials involving a small number of patients. Preparations are currently underway for the submission of Clinical Trial Notifications to the PMDA.

Renalys remains committed to delivering sparsentan as quickly as possible to patients in Japan and across Asia, with the goal of improving the lives of individuals affected by kidney diseases through the development of innovative therapeutic options.

About sparsentan

Sparsentan is an oral dual endothelin and angiotensin II receptor antagonist developed by Travere Therapeutics, Inc. ("Travere"). Renalys has an exclusive license for development and commercialization of sparsentan in Japan and several Asian territories. In Japan, data collection for the primary endpoint has been completed for all evaluable patients in the Phase Ⅲ clinical trial of IgA nephropathy, with topline results expected in Q4 2025. In 2024, Travere received full FDA approval for sparsentan (U.S. brand name: FILSPARI®) to slow kidney function decline in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression*. Full approval is based on positive long-term confirmatory results from the PROTECT Study demonstrating that FILSPARI® significantly slowed kidney function decline over two years compared to irbesartan.  In the PROTECT Study, the only head-to-head study in IgA nephropathy versus an active comparator, FILSPARI® demonstrated a significant reduction in proteinuria, preservation of kidney function and a well-tolerated safety profile compared with active control irbesartan. In Europe, it also obtained standard EU approval for the IgA nephropathy indication in 2025. In 2025, the FDA accepted for review Travere's supplemental new drug application (sNDA) for FILSPARI® for the treatment of focal segmental glomerulosclerosis (FSGS).

*FILSPARI® (sparsentan) U.S. Indication:
FILSPARI® is an endothelin and angiotensin II receptor antagonist indicated to slow kidney function decline in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression.

About Focal Segmental Glomerulosclerosis (FSGS)

Chronic kidney disease (CKD) and end-stage renal disease (ESRD) impose a significant burden on Japan's healthcare system and represent a major social issue. FSGS is recognized as an important cause of kidney failure, with many patients progressing to ESRD requiring dialysis. The disease is characterized by focal and segmental sclerosis of glomeruli, which impairs renal filtration function. FSGS is classified as one of the designated intractable nephrotic syndromes (designated intractable disease No. 222) in Japan. Because the precise mechanisms underlying disease onset and progression remain unclear and steroid-resistant cases exist, treatment can be challenging. Currently, therapeutic options for FSGS in Japan are limited, creating a significant unmet medical need.

About Alport Syndrome (AS)

AS is a hereditary kidney disorder characterized by hematuria and proteinuria that begin in childhood and progressively lead to renal impairment. The disease results from mutations in genes encoding type IV collagen, causing structural defects in the glomerular basement membrane and consequent renal dysfunction. Severe cases often progress to end-stage renal disease in male patients during late adolescence or early adulthood and may also present with hearing loss or ocular symptoms. As a rare disease (designated intractable disease No. 218), AS remains without an established curative treatment, and effective therapeutic options are urgently needed.

About Renalys Pharma, Inc.

Renalys Pharma, a privately held late-stage clinical biopharmaceutical company based in Japan, is committed to the development of innovative therapeutics targeting unmet needs in the management of renal disease for Japanese and Asian patients. Founded by Catalys Pacific and SR One, the company aims to address the growing "drug loss" in the region by catalyzing access to new treatments for kidney disease patients.  

Company Name: Renalys Pharma, Inc.
Address: 3-11, Nihonbashi-honcho 2-chome, Chuo-ku, Tokyo, Japan
Representative: BT Slingsby, MD, PhD, MPH
Established: April 2023
URL: https://renalys.com/

[Disclaimer]

Information concerning pharmaceutical products (compound under development) contained herein is not intended as advertising or as medical advice, but intended for disclosure of management information.

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SOURCE Renalys Pharma, Inc.