Filspari

For primary immunoglobulin A nephropathy (IgAN). NDA 216403, held by Travere. Sparsentan.

As of Nov 13, 2026, NDA 216403 (Filspari), held by Travere, was first approved by FDA on Feb 17, 2023, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 17, 2023
Review: Priority
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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 ). 1.1 Immunoglobulin A Nephropathy FILSPARI is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 13, 2026	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Summary Review Letter Label Medication Guide
Aug 27, 2025	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review Letter Label Medication Guide
Sep 5, 2024	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Label Letter
Feb 17, 2023	Original applicationNew molecular entity · Priority review	Approved	REMS Review Medication Guide Letter

Products

2 strengths and forms

Product	Active ingredient	Marketing
Filspari200MG · tablet;oral	Sparsentan	RxReference drug
Filspari400MG · tablet;oral	Sparsentan	RxReference drug

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 13, 2026	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Summary Review Letter Label Medication Guide
Aug 27, 2025	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review Letter Label Medication Guide
Sep 5, 2024	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Label Letter
Oct 18, 2023	Supplement 2REMS	Approved	Letter
Feb 17, 2023	Original applicationNew molecular entity · Priority review	Approved	REMS Review Medication Guide Letter

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: FILSPARIJul 28, 2026

Identifiers

Application: NDA 216403
Drugs@FDA: Overview at FDA
Company: Travere Therapeutics

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters