Prescription medicine
Sparsentan Brand names: Filspari
Sparsentan (Filspari) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the sparsentan FDA label on DailyMed (effective April 9, 2026, Travere Therapeutics, Inc.); the NDA 216403 record on Drugs@FDA; every sparsentan label on DailyMed.
Highlights of the record
FDA label of April 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 )]. […]
Used for
From the label: indications and usageFILSPARI is an endothelin and angiotensin II receptor antagonist indicated:
To slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression ( 1.1 , 12.1 , 14.1 ).
Forms and strengths
- 200 mg
- 400 mg
Film-coated tablet.
On the market
- Earliest approval on file
- February 17, 2023 Filspari, Travere; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 29, 2030 Filspari tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 5,866 through July 30, 2026
What is sparsentan used for?
From the label: indications and usageFILSPARI is an endothelin and angiotensin II receptor antagonist indicated:
To slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression ( 1.1 , 12.1 , 14.1 ). […]
FDA pharmacologic class: Angiotensin 2 Receptor Blocker and Endothelin Receptor Antagonist.
Source: FDA drug label (FILSPARI), Travere Therapeutics, Inc., effective April 9, 2026 (SPL set d7354af1-f304-f4d9-e053-2995a90ab219), via openFDA; the full label on DailyMed
What does the patient leaflet for sparsentan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about FILSPARI?FILSPARI can cause serious side effects, including: • Liver problems. o FILSPARI can cause changes in liver tests. Liver failure was not observed in people treated with FILSPARI in clinical studies, but some medicines that are like FILSPARI have caused liver failure. Your healthcare provider will do blood tests to check your liver before starting treatment with FILSPARI and then every 3 months during treatment. Your healthcare provider may temporarily stop or permanently stop treatment with FILSPARI if you have changes in your liver tests. Stop taking FILSPARI and get medical help right away if you develop any of the following signs of liver problems during treatment with FILSPARI: • nausea or vomiting • pain on the upper right side of your stomach area • tiredness • loss of appetite • yellowing of your skin or the white part of your eyes (jaundice) • dark “tea-colored” urine • fever • itching Because of the risk for liver problems, FILSPARI is only available through a restricted access program called the FILSPARI Risk Evaluation and Mitigation Strategy (REMS). Before you begin treatment with FILSPARI, your healthcare prescriber will explain the FILSPARI REMS, you must read, and agree to all of the requirements of the FILSPARI REMS. • Serious birth defects. FILSPARI can cause serious birth defects if taken during pregnancy. o Patients who can become pregnant should not be pregnant when they start taking FILSPARI or become pregnant during treatment with FILSPARI or for two weeks after stopping treatment with FILSPARI. o Patients who can become pregnant should have a negative pregnancy test before starting treatment with FILSPARI. […]
From the patient leaflet: How should I store FILSPARI?Store FILSPARI at room temperature between 68°F to 77°F (20°C to 25°C). • Store FILSPARI in the original container. • The bottle has a child-resistant closure. Keep FILSPARI and all medicines out of the reach of children.
Source: FDA drug label (FILSPARI), Travere Therapeutics, Inc., effective April 9, 2026 (SPL set d7354af1-f304-f4d9-e053-2995a90ab219), via openFDA; the full label on DailyMed
Is there a generic for sparsentan (Filspari)?
No generic sparsentan is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Filspari tablets, the last expiring on March 29, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2030 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the sparsentan label say about other medicines?
The sparsentan label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aliskiren | contraindications | Do not co-administer FILSPARI with ARBs, ERAs, or aliskiren [see Dosage and Administration ( 2.1 ), Drug Interactions ( 7.1 )]. |
| Irbesartan | warnings and precautions | In clinical trials, there was a greater incidence of hypotension-associated adverse events, some serious, including dizziness, in patients treated with FILSPARI compared to irbesartan [see Adverse Reactions ( 6.1 )]. |
Source: FDA drug label (FILSPARI), Travere Therapeutics, Inc., effective April 9, 2026 (SPL set d7354af1-f304-f4d9-e053-2995a90ab219), via openFDA; the full label on DailyMed
What do FAERS reports show for sparsentan?
The FDA Adverse Event Reporting System holds 5,866 reports that list sparsentan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 32 are coded as a death and 405 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (2,395, against a median of 2 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other ARBs
- the pharmacologic class, with prices and generics
- Sparsentan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other