Filspari

(Sparsentan)

ApprovedSmall molecule

Filspari is a small molecule that works as a Endothelin/angiotensin Receptor Antagonist.[2] It is being used across 5 indications, with its most advanced program in Approved.[1]

Filspari is one of 59 small molecule programs targeting Proteinuria. 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

ProteinuriaActive, not recruiting

ANCA-Associated VasculitisActive, not recruiting

Iga NephropathyCompleted

Glomerular DiseaseRecruiting

Focal Segmental GlomerulosclerosisActive, not recruiting

ProteinuriaApproved

Active, not recruiting

ANCA-Associated VasculitisPhase 2

Active, not recruiting

Iga NephropathyPhase 3

Completed

Glomerular DiseasePhase 2

Recruiting

Focal Segmental GlomerulosclerosisPhase 3

Active, not recruiting

Competition

Competitive Landscape

43 competitors in Iga Nephropathy

#DrugCompanyPhaseTrials

Cellcept

Roche

Approved

7 2

Rituxan

Roche

Approved

2 3

Lorelco

Sanofi

Approved

1 4

Fabhalta

Novartis

Approved

—5

Filspari

TTravere Therapeutics, Inc.

Approved

2 6

Tekturna

Tibotec Pharmaceuticals, Ireland

Approved

1 7

Velcade

SShilpa Grover, MD, MPH

Approved

1 8

Kerendia

Bayer

Phase 3

2 9

Farxiga

AstraZeneca

Phase 3

1 10

Vanrafia

Novartis

Phase 3

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]

IgA Nephropathy2 trials

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

Active, not recruiting·TTravere Therapeutics, Inc.·Phase 3·NCT03762850·406 enrolled

PROTECT: Sparsentan in IgA Nephropathy

Completed· Takeda logo

Takeda·Phase 3·NCT04663204·404 enrolled

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

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

2 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

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

Filspari

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Q4 2028

Trials by Indication[1]

IgA Nephropathy2 trials

Focal Segmental Glomerulosclerosis1 trial

IgAN1 trial

Glomerular Disease1 trial

ANCA-Associated Vasculitis1 trial

Proteinuric Renal Disease1 trial

Proteinuria1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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