Quick answers
- What is Sparsentan used for?
- The FDA-approved label (Filspari, Travere Therapeutics, Inc., April 9, 2026) says: “FILSPARI 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 ). • To reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome ( 1.2, 12.1, 14.2 ). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sparsentan have a boxed warning?
- Yes. The FDA label for Filspari has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Sparsentan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sparsentan been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sparsentan?
- 1 company lists prescription products of Sparsentan in the FDA NDC Directory, including Travere Therapeutics, Inc..
What Sparsentan is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
FILSPARI 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 ). • To reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome ( 1.2, 12.1, 14.2 ). …
— FDA label: Filspari, Travere Therapeutics, Inc., effective April 9, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Filspari |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Travere Therapeutics, Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA216403 FILSPARI | Travere | February 17, 2023 | 4, latest April 13, 2026 2026: Efficacy · 2025: Efficacy · 2024: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2630540, 2630546, 2630548, 2630550 |
|---|---|
| SPL set ID of the quoted label | d7354af1-f304-f4d9-e053-2995a90ab219 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA216403 |
| Active ingredients (FDA) | SPARSENTAN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Filspari, Travere Therapeutics, Inc., effective April 9, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →