DelveInsight’s analysis shows that the Focal Segmental Glomerulosclerosis (FSGS) pipeline involves over 15 key companies actively developing more than 18 therapies for FSGS treatment.
Focal Segmental Glomerulosclerosis Overview:
Focal Segmental Glomerulosclerosis (FSGS) is a major cause of idiopathic steroid-resistant nephrotic syndrome (SRNS) and can progress to end-stage kidney disease (ESKD). Its development involves complex interactions among multiple cell types, including podocytes, endothelial cells, and the glomerular basement membrane. Podocytes—highly specialized, non-regenerative cells—are essential for maintaining glomerular structure and the integrity of the filtration barrier, preventing excessive protein loss in urine. Damage or loss of podocytes prompts compensatory hypertrophy in the remaining cells, resulting in foot process effacement and proteinuria.
As FSGS progresses, there is proliferation of mesangial, endothelial, and epithelial cells, followed by collapse or contraction of glomerular capillaries, ultimately causing glomerulosclerosis (scarring of the glomeruli). Podocyte injury can be triggered by viral or toxic exposures or changes in intrarenal blood flow, such as elevated glomerular pressure and hyperperfusion.
Several morphological variants of FSGS have been described, including the collapsing type (linked to mesangial hypercellularity), the cellular variant (marked by endocapillary and extracapillary hypercellularity), and the tip lesion variant.
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“Focal Segmental Glomerulosclerosis Pipeline Insight 2025” report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the Focal Segmental Glomerulosclerosis Therapeutics Market.
Key Takeaways from the Focal Segmental Glomerulosclerosis Pipeline Report
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DelveInsight’s Focal Segmental Glomerulosclerosis (FSGS) pipeline report highlights a dynamic landscape, with over 15 active companies developing more than 18 therapies for FSGS treatment.
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In March 2025, Travere Therapeutics submitted a supplemental New Drug Application (sNDA) to the FDA requesting priority review for FILSPARI® (sparsentan) as a treatment for FSGS. If approved, FILSPARI would become the first FDA-approved therapy for this rare kidney disease.
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The sNDA is supported by data from the Phase 3 DUPLEX Study and Phase 2 DUET Study, among the largest interventional trials conducted in FSGS patients. While the DUPLEX Study did not achieve its primary efficacy endpoint over 108 weeks, it showed notable proteinuria reduction and higher remission rates compared to the active control.
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Travere’s pursuit of FDA approval is based on the significant reduction in proteinuria, which is recognized as a meaningful marker of treatment benefit in FSGS. The FDA has indicated willingness to consider proteinuria reduction as a surrogate endpoint for approval in FSGS therapies.
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Key companies involved in FSGS drug development include Dimerix Bioscience, Travere Therapeutics, Horizon Therapeutics, Pfizer, Goldfinch Bio, Certa Therapeutics, ZyVersa Therapeutics, Vertex Pharmaceuticals, Chinook Therapeutics, Delta 4, and others.
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Prominent pipeline candidates at various stages of development include DMX-200, Sparsentan, Dazodalibep, and others.
Focal Segmental Glomerulosclerosis Pipeline Analysis
The Focal Segmental Glomerulosclerosis pipeline insights report 2025, provides insights into:
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Provides comprehensive insights into key companies developing therapies in the Focal Segmental Glomerulosclerosis Market.
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Categorizes Focal Segmental Glomerulosclerosis therapeutic companies by development stage: early, mid, and late-stage.
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Highlights major companies involved in targeted therapy development, including both active and inactive (paused/discontinued) projects.
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Reviews emerging Focal Segmental Glomerulosclerosis drugs under development based on:
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Stage of development
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Focal Segmental Glomerulosclerosis Route of administration
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Target receptor
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Monotherapy vs. combination therapy
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Focal Segmental Glomerulosclerosis Mechanism of action
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Molecular type
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Offers detailed analysis of:
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Company-to-company and company-academia collaborations
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Focal Segmental Glomerulosclerosis Licensing agreements
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Funding and investment activities supporting future Focal Segmental Glomerulosclerosis market advancement.
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Focal Segmental Glomerulosclerosis Emerging Drugs
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DMX-200: Dimerix Bioscience
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Sparsentan: Travere Therapeutics
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Dazodalibep: Horizon Therapeutics
Focal Segmental Glomerulosclerosis Companies
Around 15 or more prominent companies are actively working on developing therapies for Focal Segmental Glomerulosclerosis (FSGS). Among these, Dimerix Bioscience stands out with a drug candidate that has reached the most advanced stage of development—Phase III clinical trials.
DelveInsight’s report covers around 18+ products under different phases of Focal Segmental Glomerulosclerosis clinical trials like
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Focal Segmental Glomerulosclerosis Late stage Therapies (Phase III)
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Focal Segmental Glomerulosclerosis Mid-stage Therapies (Phase II)
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Focal Segmental Glomerulosclerosis Early-stage Therapies (Phase I)
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Focal Segmental Glomerulosclerosis Pre-clinical and Focal Segmental Glomerulosclerosis Discovery stage Therapies
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Focal Segmental Glomerulosclerosis Discontinued & Inactive Therapies
Focal Segmental Glomerulosclerosis pipeline report provides the Focal Segmental Glomerulosclerosis therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
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Intravenous
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Subcutaneous
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Oral
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Intramuscular
Focal Segmental Glomerulosclerosis Products have been categorized under various Molecule types such as
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Monoclonal antibody
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Small molecule
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Peptide
Download Sample Pages to Get an in-depth Assessment of the Emerging Focal Segmental Glomerulosclerosis Therapies and Key Focal Segmental Glomerulosclerosis Companies: Focal Segmental Glomerulosclerosis Clinical Trials and recent advancements
Focal Segmental Glomerulosclerosis Pipeline Therapeutic Assessment
• Focal Segmental Glomerulosclerosis Assessment by Product Type
• Focal Segmental Glomerulosclerosis By Stage
• Focal Segmental Glomerulosclerosis Assessment by Route of Administration
• Focal Segmental Glomerulosclerosis Assessment by Molecule Type
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Table of Content
1. Report Introduction
2. Executive Summary
3. Focal Segmental Glomerulosclerosis Current Treatment Patterns
4. Focal Segmental Glomerulosclerosis – DelveInsight’s Analytical Perspective
5. Therapeutic Assessment
6. Focal Segmental Glomerulosclerosis Late-Stage Products (Phase-III)
7. Focal Segmental Glomerulosclerosis Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Focal Segmental Glomerulosclerosis Discontinued Products
13. Focal Segmental Glomerulosclerosis Product Profiles
14. Focal Segmental Glomerulosclerosis Key Companies
15. Focal Segmental Glomerulosclerosis Key Products
16. Dormant and Discontinued Products
17. Focal Segmental Glomerulosclerosis Unmet Needs
18. Focal Segmental Glomerulosclerosis Future Perspectives
19. Focal Segmental Glomerulosclerosis Analyst Review
20. Appendix
21. Report Methodology
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