Focal Segmental Glomerulosclerosis Pipeline Insight 2025: 18+ Emerging Therapies, Targeted Treatments, and Novel Mechanisms Aim to Transform Care | DelveInsight

DelveInsight's "Focal Segmental Glomerulosclerosis - Pipeline Insight, 2025" reviews more than 18+ therapies in development for focal segmental glomerulosclerosis (FSGS), a rare and severe form of chronic kidney disease often leading to end-stage renal failure. Current treatment strategies, including corticosteroids, calcineurin inhibitors, and supportive therapies, provide limited efficacy, leaving a high unmet need in the FSGS treatment market.

The FSGS pipeline is broadening with novel mechanisms of action, including endothelin receptor antagonists, dual-acting molecules, complement inhibitors, and precision immunotherapies designed to reduce proteinuria and slow disease progression. Key approaches under investigation include anti-fibrotic therapies, podocyte-protective agents, and gene-targeted interventions, reflecting a shift toward disease-modifying strategies rather than symptomatic relief.

With several late-stage candidates advancing in clinical development, the therapeutic focus in FSGS is evolving beyond traditional immunosuppression. As investigational drugs demonstrate potential to improve renal outcomes and delay dialysis or transplant dependency, the FSGS treatment landscape is set to transform, offering patients hope for more durable and targeted solutions.

Interested in learning more about the current treatment landscape and the key drivers shaping the Focal Segmental Glomerulosclerosis pipeline? Click here: https://www.delveinsight.com/report-store/focal-segmental-glomerulosclerosis-fsgs-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Focal Segmental Glomerulosclerosis Pipeline Report
• DelveInsight's Focal Segmental Glomerulosclerosis pipeline analysis depicts a strong space with 15+ active players working to develop 18+ pipeline drugs for Focal Segmental Glomerulosclerosis treatment.
• The leading Focal Segmental Glomerulosclerosis companies include Dimerix Bioscience, Travere Therapeutics, Horizon Therapeutics, Pfizer, Goldfinch Bio, and others are evaluating their lead assets to improve the Focal Segmental Glomerulosclerosis treatment landscape.
• Key Focal Segmental Glomerulosclerosis pipeline therapies in various stages of development include DMX-200, Sparsentan, Dazodalibep, PF-06730512, GFB-887, and others.
• In September 2025, Travere Therapeutics (Nasdaq: TVTX) announced that the FDA no longer requires an advisory committee review for the sNDA of FILSPARI® (sparsentan) in FSGS. The application remains under review, with a PDUFA date set for January 13, 2026.
• In May 2025, Travere Therapeutics announced that the FDA accepted its sNDA for FILSPARI (sparsentan) for focal segmental glomerulosclerosis (FSGS), with a PDUFA target date of January 13, 2026. An advisory committee meeting is also planned.

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Focal Segmental Glomerulosclerosis Overview
Focal Segmental Glomerulosclerosis (FSGS) is a kidney disorder characterized by scarring (sclerosis) in some segments of the glomeruli-the tiny filtering units within the kidney. This scarring leads to impaired kidney function and often results in proteinuria (excess protein in the urine), swelling, and eventually chronic kidney disease or kidney failure. FSGS can be primary (idiopathic) or secondary to other conditions such as infections, drug toxicity, or genetic mutations.

The disease is challenging to treat and often requires immunosuppressive therapies like corticosteroids, although response rates vary. Management also includes controlling symptoms such as hypertension and proteinuria with medications like ACE inhibitors or ARBs. FSGS is a leading cause of nephrotic syndrome in adults and children and is a significant contributor to end-stage renal disease worldwide.

Find out more about Focal Segmental Glomerulosclerosis medication at https://www.delveinsight.com/report-store/focal-segmental-glomerulosclerosis-fsgs-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Focal Segmental Glomerulosclerosis Treatment Analysis: Drug Profile
Sparsentan: Travere Therapeutics
Sparsentan is a Dual Endothelin Angiotensin Receptor Antagonist (DEARA) that targets both the endothelin A receptor (ETAR) and angiotensin II type 1 receptor (AT1R). Preclinical studies show that blocking these pathways helps reduce proteinuria, protect podocytes, and prevent kidney scarring in chronic kidney diseases like FSGS. The FDA and EMA have granted sparsentan orphan drug status for FSGS. In March 2025, the FDA accepted Travere's supplemental New Drug Application for traditional approval of FILSPARI (sparsentan) to treat FSGS, with a PDUFA target date of January 13, 2026, and plans for an advisory committee meeting.

DMX-200: Dimerix Bioscience
DMX-200 is a chemokine receptor 2 (CCR2) blocker designed to be used alongside angiotensin II type 1 receptor blockers (ARBs), the current standard treatment for FSGS. It has received patents through 2032 and orphan drug designation from the FDA and EMA. In a Phase IIa trial in 2020, DMX-200 demonstrated safety, tolerability, and clinical benefit in FSGS patients. It is now in Phase III trials for FSGS treatment.

WAL0921: Walden Biosciences
WAL0921 is a first-in-class humanized monoclonal antibody that targets soluble urokinase plasminogen activator receptor (suPAR), a pro-inflammatory protein implicated in podocyte damage and kidney disease progression. Elevated suPAR levels are linked to worsening kidney function in FSGS. By blocking suPAR, WAL0921 aims to prevent podocyte injury and slow disease progression. The drug is currently in Phase II development for FSGS.

Learn more about the novel and emerging Focal Segmental Glomerulosclerosis pipeline therapies at https://www.delveinsight.com/report-store/focal-segmental-glomerulosclerosis-fsgs-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Focal Segmental Glomerulosclerosis Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Intramuscular

By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide

Scope of the Focal Segmental Glomerulosclerosis Pipeline Report
• Coverage: Global
• Key Focal Segmental Glomerulosclerosis Companies: Dimerix Bioscience, Travere Therapeutics, Horizon Therapeutics, Pfizer, Goldfinch Bio, and others.
• Key Focal Segmental Glomerulosclerosis Pipeline Therapies: DMX-200, Sparsentan, Dazodalibep, PF-06730512, GFB-887, and others.

To dive deep into rich insights for drugs used for Focal Segmental Glomerulosclerosis treatment, visit: https://www.delveinsight.com/report-store/focal-segmental-glomerulosclerosis-fsgs-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Focal Segmental Glomerulosclerosis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Focal Segmental Glomerulosclerosis Pipeline Therapeutics
6. Focal Segmental Glomerulosclerosis Pipeline: Late-Stage Products (Phase III)
7. Focal Segmental Glomerulosclerosis Pipeline: Mid-Stage Products (Phase II)
8. Focal Segmental Glomerulosclerosis Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

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This release was published on openPR.