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 133 small molecule programs targeting Vasculitis. It is currently in Approved.

Indications

Total Trials

Active Trials

132

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

VasculitisActive, not recruiting

Glomerular DiseaseActive, not recruiting

ProteinuriaActive, not recruiting

Iga NephropathyActive, not recruiting

Focal Segmental GlomerulosclerosisActive, not recruiting

VasculitisPhase 2

Active, not recruiting

Glomerular DiseasePhase 2

Active, not recruiting

ProteinuriaApproved

Active, not recruiting

Iga NephropathyPhase 3

Active, not recruiting

Focal Segmental GlomerulosclerosisPhase 3

Active, not recruiting

Competition

Competitive Landscape

99 competitors in Iga Nephropathy

#DrugCompanyPhaseTrials

Filspari

TTravere Therapeutics, Inc.

Approved

2 2

Avapro

Sanofi

Phase 3

3 3

Kerendia

Bayer

Phase 3

2 4

Farxiga

AstraZeneca

Phase 3

1 5

Deltasone

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Phase 3

2 6

LNP023

Novartis

Phase 3

1 7

Medrol

Pfizer

Phase 2

3 8

Telitacicept

VVor Biopharma

Phase 3

5 9

Mezagitamab

Atacicept

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

Vasculitis

NCT05630612

Q4 2028

Phase 1Not yet recruiting

Proteinuria

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

Proteinuria2 trials

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

Not yet recruiting·—·Phase 1·NCT07224776·20 enrolled

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

Glomerular Disease1 trial

Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases

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

Vasculitis1 trial

ETA and AT1 Antagonism in ANCA-vasculitis (SPARVASC)

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

1 more indication

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

Regulatory

FDA Approval Timeline[4]

Feb 17, 2023

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

Proteinuria2 trials

Glomerular Disease1 trial

Vasculitis1 trial

Focal Segmental Glomerulosclerosis1 trial

IgAN1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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