Is Sparsentan approved by the US FDA?

Drugs@FDA lists 1 application product line for Sparsentan, including FILSPARI (Prescription).

Is Sparsentan authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Sparsentan: Filspari.

Are there safety signals or safety updates for Sparsentan?

US FDA: 1 entry (latest 2026-04-13).

Active substance

Sparsentan

US FDA 1
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
FILSPARI	200MG; 400MG	tablet · oral	TRAVERE	Prescription	17 Feb 2023

EMA European Union — centrally authorised medicines

Filspari Vifor France · Authorised · authorised 19 Apr 2024 · ATC C09XX01

Therapeutic indication (EMA)

Filspari is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion > 1.0 g/day (or urine protein-to-creatinine ratio > 0.75 g/g, see section 5.1).

Safety signals and safety-related labeling changes

US FDA 13 Apr 2026 FILSPARI — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for sparsentan →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.