Sparsentan History and Updates

47 events · 2012 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: August 13, 2026.

FDA Approvals

Label Revisions

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-07-31Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Sparsentan since 2012, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (6)

2026

FDA approval (supplemental)Filspari (sparsentan) Receives FDA Supplemental Approval for Efficacy· Apr 13, 2026

2025

Results postedSparsentan Phase 2 Study in IgAN Shows Significant UA/C Reduction· Nov 20, 2025
FDA approval (supplemental)Filspari (Sparsentan) Supplemental Application for Efficacy Approved by FDA· Aug 27, 2025

2024

Pivotal publicationSparsentan vs. Irbesartan Study for Focal Segmental Glomerulosclerosis Published· Jan 1, 2024

2023

Pivotal publicationSparsentan Interim Analysis for IgA Nephropathy Trial Published· Jan 1, 2023
Pivotal publicationSparsentan 2-Year Phase 3 Results Published for IgA Nephropathy· Jan 1, 2023

Upcoming & expected milestones

Primary completionDec 1, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT07224776

Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria

Primary completionMar 12, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT05003986

Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases

Primary completionMar 31, 2027· ClinicalTrials.gov

Phase 4 primary completion: NCT07219121

Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis

Primary completionDec 31, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT04663204

A Study of the Safety and Activity of Sparsentan for the Treatment of Patients With Immunoglobulin A Nephropathy

Primary completionDec 31, 2028· ClinicalTrials.gov

Primary completion: NCT07555301

Clinical Experience With Sparsentan in Switzerland in IgA Nephropathy

Past events

2026

Trial startedJun 10, 2026· ClinicalTrials.gov

Phase 1 trial started: NCT07224776

Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria

Trial startedJun 1, 2026· ClinicalTrials.gov

Trial started: NCT07555301

Clinical Experience With Sparsentan in Switzerland in IgA Nephropathy

Trial registeredApr 29, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07555301

Clinical Experience With Sparsentan in Switzerland in IgA Nephropathy

FDA approval (supplemental)Apr 13, 2026· FDA

FDA approved supplemental application for Filspari (sparsentan) — Efficacy (NDA 216403 S-6)

Sponsor: TRAVERE. Class: Efficacy.

Trial startedMar 1, 2026· ClinicalTrials.gov

Phase 1 trial started: NCT07224776

Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria

2025

Results postedNov 20, 2025· ClinicalTrials.gov

Trial results posted: NCT05856760

A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN

Trial registeredNov 5, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT07224776

Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria

Trial registeredOct 21, 2025· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07219121

Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis

Trial startedOct 7, 2025· ClinicalTrials.gov

Phase 4 trial started: NCT07219121

Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis

FDA approval (supplemental)Aug 27, 2025· FDA

FDA approved supplemental application for Filspari (sparsentan) — Efficacy (NDA 216403 S-5)

Sponsor: TRAVERE. Class: Efficacy.

Primary completionMar 31, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT04663204

A Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients With Immunoglobulin A Nephropathy

2024

Primary completionOct 14, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT05856760

A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN

FDA approval (supplemental)Sep 5, 2024· FDA

FDA approved supplemental application for Filspari (sparsentan) — Efficacy (NDA 216403 S-3)

Sponsor: TRAVERE. Class: Efficacy.

Primary completionJul 18, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT05630612

ETA and AT1 Antagonism in ANCA-vasculitis (SPARVASC)

Results postedJul 3, 2024· ClinicalTrials.gov

Trial results posted: NCT03762850

A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy

Results postedApr 30, 2024· ClinicalTrials.gov

Trial results posted: NCT03493685

Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

Pivotal publicationJan 1, 2024· PubMed

Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis. (N Engl J Med)

DUPLEX — Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

2023

FDA approval (supplemental)Oct 18, 2023· FDA

FDA approved supplemental application for Filspari (sparsentan) — REMS (NDA 216403 S-2)

Sponsor: TRAVERE. Class: REMS.

Primary completionAug 7, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT03762850

A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy

Trial startedMay 19, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05856760

A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN

Trial registeredMay 12, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05856760

A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN

Primary completionMar 20, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT03493685

Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

FDA approvalFeb 17, 2023· FDA

FDA approved Filspari (sparsentan) (NDA 216403)

Sponsor: TRAVERE. Class: Type 1 - New Molecular Entity.

Pivotal publicationJan 1, 2023· PubMed

Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial. (Lancet)

PROTECT — A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy

Pivotal publicationJan 1, 2023· PubMed

Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 tri (Lancet)

PROTECT — A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy

2022

Trial startedDec 8, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05630612

ETA and AT1 Antagonism in ANCA-vasculitis (SPARVASC)

Trial registeredNov 29, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05630612

ETA and AT1 Antagonism in ANCA-vasculitis (SPARVASC)

Trial registeredSep 30, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05562362

Study to Evaluate the Pharmacokinetics of Oral Sparsentan Suspension

2021

Trial registeredAug 13, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05003986

Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases

Trial startedAug 12, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT05003986

Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases

Results postedJul 27, 2021· ClinicalTrials.gov

Trial results posted: NCT01613118

Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis

2020

Trial registeredDec 10, 2020· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04663204

A Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients With Immunoglobulin A Nephropathy

Trial startedDec 10, 2020· ClinicalTrials.gov

Phase 2 trial started: NCT04663204

A Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients With Immunoglobulin A Nephropathy

Primary completionNov 12, 2020· ClinicalTrials.gov

Phase 1 primary completion: NCT05562362

Study to Evaluate the Pharmacokinetics of Oral Sparsentan Suspension

Trial startedJun 18, 2020· ClinicalTrials.gov

Phase 1 trial started: NCT05562362

Study to Evaluate the Pharmacokinetics of Oral Sparsentan Suspension

2018

Trial startedDec 11, 2018· ClinicalTrials.gov

Phase 3 trial started: NCT03762850

A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy

Trial registeredDec 4, 2018· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03762850

A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy

Trial startedApr 17, 2018· ClinicalTrials.gov

Phase 3 trial started: NCT03493685

Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

Trial registeredApr 10, 2018· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03493685

Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

2016

Primary completionJun 30, 2016· ClinicalTrials.gov

Phase 2 primary completion: NCT01613118

Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis

2014

Trial startedMar 31, 2014· ClinicalTrials.gov

Phase 2 trial started: NCT01613118

Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis

2012

Trial registeredJun 6, 2012· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT01613118

Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.