Filspari

(Sparsentan)

ApprovedSmall molecule

Filspari is a small molecule that works as a Endothelin/angiotensin Receptor Antagonist.[2] It is being used across 4 indications, with its most advanced program in Approved.[1]

Filspari is one of 31 small molecule programs targeting Glomerular Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Glomerular DiseaseRecruiting

ProteinuriaActive, not recruiting

ANCA-Associated VasculitisActive, not recruiting

Focal Segmental GlomerulosclerosisActive, not recruiting

Glomerular DiseasePhase 2

Recruiting

ProteinuriaApproved

Active, not recruiting

ANCA-Associated VasculitisPhase 2

Active, not recruiting

Focal Segmental GlomerulosclerosisPhase 3

Active, not recruiting

Competition

Competitive Landscape

14 competitors in Proteinuria

#DrugCompanyPhaseTrials

Farxiga

AstraZeneca

Approved

3 2

Rocaltrol

Jazz Pharmaceuticals

Approved

1 3

Zemplar

AbbVie

Approved

—4

Trental

VValidus Pharmaceuticals

Approved

1 5

Midamor

PPadagis LLC

Approved

1 6

Filspari

TTravere Therapeutics, Inc.

Approved

1 7

Dyrenium

AAdvanz Pharma

Approved

1 8

Cysteine Hydrochloride

Novartis

Preclinical

1 9

Tyzeka

Novartis

Preclinical

1 10

AP1189

SSynAct Pharma Aps

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Glomerular Disease

NCT05003986

ApprovedActive, not recruiting

Proteinuria

NCT07219121

Q3 2027

Phase 2Active, not recruiting

ANCA-Associated Vasculitis

NCT05630612

Q4 2028

Phase 1Recruiting

Proteinuric Renal Disease

NCT07224776

Clinical

Trials by Indication[1]

Focal Segmental Glomerulosclerosis1 trial

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

Active, not recruiting·TTravere Therapeutics, Inc.·Phase 3·NCT03493685·371 enrolled

IgAN1 trial

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

Completed·TTravere Therapeutics, Inc.·Phase 2·NCT05856760·48 enrolled

Glomerular Disease1 trial

Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases

Recruiting·TTravere Therapeutics, Inc.·Phase 2·NCT05003986·67 enrolled

Immunoglobulin A Nephropathy1 trial

A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy

Completed·TTravere Therapeutics, Inc.·Phase 3·NCT03762850·406 enrolled

ANCA-Associated Vasculitis1 trial

Effects of Simultaneous ETA & AT1 Receptor Antagonism on Endothelial Function & Vascular Stiffness in ANCA-associated Vasculitis (SPARsentan in VASCulitis - SPARVASC)

Active, not recruiting·UUniversity of Edinburgh·Phase 2·NCT05630612·32 enrolled

3 more indications

Proteinuric Renal Disease1 trial

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

Recruiting·BBrigham and Women's Hospital·Phase 1·NCT07224776·20 enrolled

Proteinuria1 trial

A Multicenter, Open-label Single Arm Study to Evaluate the Safety and Efficacy of Sparsentan in Posttransplant Immunoglobulin A Nephropathy (IgAN) or Focal Segmental Glomerulosclerosis (FSGS) (SPARX)

Active, not recruiting·TTravere Therapeutics, Inc.·Approved·NCT07219121·20 enrolled

IgA Nephropathy1 trial

PROTECT: Sparsentan in IgA Nephropathy

Completed· Takeda logo

Takeda·Phase 3·NCT04663204·404 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 17, 2023

FILSPARI

NDA NDA216403

Feb 17, 2023

FILSPARI

NDA NDA216403

Oct 18, 2023

FILSPARI

NDA NDA216403

Sep 5, 2024

FILSPARI

NDA NDA216403

Aug 27, 2025

FILSPARI

NDA NDA216403

Apr 13, 2026

FILSPARI

NDA NDA216403

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Sparsentan. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sparsentan compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sparsentan. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA216403). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Filspari. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Travere Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Endothelin/angiotensin Receptor Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: TTravere Therapeutics, Inc.

Patent Landscape[5]

Patent Cliff

Mar 29, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9993461Mar 29, 2030

9662312Mar 29, 2030

12714697Oct 13, 2037

Filspari

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Q4 2028

Trials by Indication[1]

Focal Segmental Glomerulosclerosis1 trial

IgAN1 trial

Glomerular Disease1 trial

Immunoglobulin A Nephropathy1 trial

ANCA-Associated Vasculitis1 trial

Proteinuric Renal Disease1 trial

Proteinuria1 trial

IgA Nephropathy1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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