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FDA Grants Accelerated Approval to Sparsentan for Reducing Proteinuria in IgA Nephropathy

Release date: 2026-03-18 16:29:47     Recommended: 63

Sparsentan, developed by Travere Therapeutics, is an endothelin and angiotensin II receptor antagonist. The drug received accelerated approval from the FDA in February 2023 for reducing proteinuria in patients with IgA nephropathy. Based on positive long-term data from the PROTECT study—which demonstrated that Sparsentan significantly slowed the decline in kidney function compared to irbesartan over a two-year treatment period—it received full FDA approval in May 2024 to slow the decline in kidney function in adults with primary IgA nephropathy at risk of disease progression.

Approved Indication for Sparsentan

IgA Nephropathy

Sparsentan is indicated to slow the decline in kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression.

About Sparsentan

Sparsentan is a once-daily oral medication designed to selectively target two key pathways involved in IgAN disease progression (endothelin-1 and angiotensin II). It is the first and only non-immunosuppressive therapy approved for the treatment of this condition. Sparsentan is a prescription medication used to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, typically with a UPCR ≥1.5 g/g.

About IgA Nephropathy

IgA nephropathy (IgAN) is a rare kidney disease characterized by the accumulation of immunoglobulin A (IgA) in the kidneys. The deposition of IgA in the kidneys leads to disruption of the normal filtration mechanism, resulting in proteinuria and hematuria. Other symptoms may include kidney pain, edema, and hypertension.

Important Safety Information for Sparsentan

Sparsentan carries a boxed warning for hepatotoxicity and embryo-fetal toxicity.

Warnings and precautions associated with Sparsentan include hepatotoxicity, embryo-fetal toxicity, hypotension, acute kidney injury, hyperkalemia, and fluid retention.

Common adverse reactions to Sparsentan include peripheral edema, hypotension (including orthostatic hypotension), dizziness, hyperkalemia, and anemia.