Last reviewed 2026-04-20 · How we verify

SPARSENTAN

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: HEPATOTOXICITY and EMBRYO-FETAL TOXICITY Because of the risk of hepatotoxicity, FILSPARI is available only through a restricted program called the FILSPARI REMS. Under the FILSPARI REMS, prescribers, patients, and pharmacies must enroll in the program [see Warnings and Precautions ( 5.1 , 5.2 )] . Hepatotoxicity Some Endothelin Receptor Antagonists (ERAs) have caused elevations of aminotransferases, hepatotoxicity, and liver failure. In clinical studies, elevations in aminotransferases (ALT or AST) of at least 3-times the Upper Limit of Normal (ULN) have been observed in up to 3.5% of FILSPARI-treated patients, including cases confirmed with rechallenge. Measure transaminases and bilirubin before initiating treatment and then every 3 months during treatment. Interrupt treatment and closely monitor patients who develop aminotransferase elevations more than 3-times ULN [see Dosage and Administration ( 2.2 , 2.6 ), Warnings and Precautions ( 5.1 )] . FILSPARI should generally be avoided in patients with elevated aminotransferases (>3-times ULN) at baseline because monitoring for hepatotoxicity may be more difficult and these patients may be at increased risk for serious hepatotoxicity [see Dosage and Administration ( 2.2 , 2.6 ), Warnings and Precautions ( 5.1 )] . Embryo-Fetal Toxicity FILSPARI is contraindicated for use during pregnancy because it may cause fetal harm if used by pregnant patients. Therefore, in patients who can become pregnant, exclude pregnancy prior to initiation of FILSPARI. Advise use of effective contraception before the initiation of treatment, during treatment, and for two weeks after discontinuation of treatment with FILSPARI. When pregnancy is detected, discontinue FILSPARI as soon as possible [see Dosage and Administration ( 2.3 ), Contraindications ( 4 ), Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.1 , 8.3 )]. WARNING: HEPATOTOXICITY and EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. • FILSPARI is only available through a restricted distribution program called the FILSPARI Risk Evaluation and Mitigation Strategies (REMS) because of the risk of hepatotoxicity ( 5.2 ): • Some endothelin receptor antagonists have caused elevations of aminotransferases, hepatotoxicity, and liver failure ( 5.1 ). • Measure liver aminotransferases and total bilirubin prior to initiation of treatment and ALT and AST every 3 months during treatment ( 2.2 , 2.6 , 5.1 ). • Interrupt treatment and closely monitor patients developing aminotransferase elevations more than 3-times Upper Limit of Normal (ULN) ( 2.2 , 2.6 ). • Based on animal data, FILSPARI may cause fetal harm if used during pregnancy and is contraindicated in pregnancy ( 4 , 5.3 , 8.1 ). • For patients who can become pregnant, exclude pregnancy prior to the initiation of treatment with FILSPARI ( 2.3 , 5.3 , 8.3 ). • Use effective contraception prior to initiation of treatment, during treatment, and for two weeks after stopping FILSPARI ( 4 , 5.3 , 8.1 , 8.3 ). • When pregnancy is detected, discontinue FILSPARI as soon as possible ( 5.3 ).

Common side effects

• Peripheral edema
• Hypotension (including orthostatic hypotension)
• Hyperkalemia
• Dizziness
• Anemia
• Acute kidney injury
• Transaminase elevations
• Hemoglobin decrease >2 g/dL

Serious adverse events

• Hepatotoxicity
• Embryo-Fetal Toxicity
• Acute Kidney Injury
• Hyperkalemia
• Hypotension
• Fluid Retention

Key clinical trials

• Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis (PHASE4)
• Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria (PHASE1)
• Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases (PHASE2)
• A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN (PHASE2)
• ETA and AT1 Antagonism in ANCA-vasculitis (SPARVASC) (PHASE2)
• Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) (PHASE3)
• A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy (PHASE3)
• Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis (PHASE2)

Primary sources

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