Focal Segmental Glomerulosclerosis- Pipeline Insight, 2025

DelveInsight's, "Focal Segmental Glomerulosclerosis- Pipeline Insight, 2025" report provides comprehensive insights about 15+ companies and 18+ pipeline drugs in Focal Segmental Glomerulosclerosis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Focal Segmental Glomerulosclerosis: Understanding

Focal Segmental Glomerulosclerosis: Overview

Focal Segmental Glomerulosclerosis (FSGS) is a major cause of idiopathic steroid-resistant nephrotic syndrome (SRNS) and end-stage kidney disease (ESKD). The pathogenesis of focal segmental glomerular sclerosis involves a complex interplay of several cell types, including podocytes, endothelial cells, and the basement membrane. Podocytes are terminally differentiated cells that provide structural support to the glomerulus and are essential in maintaining an intact glomerular filtration barrier, which is essential to prevent nephrotic range proteinuria. Injury and loss of podocytes result in the podocyte hypertrophy of remaining podocytes to cover the glomerular capillary surface, resulting in effacement and protein loss. Foot process effacement and the proliferation of mesangial, endothelial, and epithelial cells earlier in the course of illness, followed by collapse or shrinkage of glomerular capillaries, all result in scarring (glomerulosclerosis).

The proposed mechanism for podocyte injury includes viral- or toxin-mediated insult and intrarenal hemodynamic alterations, such as high intraglomerular capillary pressure and glomerular hyperperfusion. Many morphologic subsets, such as a collapsing variant (FSGS with mesangial hypercellularity), a cellular variant (endocapillary and extracapillary hypercellularity), and FSGS with tip lesions, are known.

Understanding the pathophysiology of FSGS has improved with the discovery that mutations in several proteins responsible for maintaining podocyte structure, function, or both not only result in FSGS but can predict disease characteristics, such as steroid responsiveness. For instance, FSGS with mutations in NPHS2 or TRPC6 is challenging to treat with immunosuppressive therapy; however, when such patients undergo kidney transplantation, the disease does not usually recur. APOL1 G1/G2 variants have been associated with a poor renal prognosis and steroid resistance in nephrotic syndrome/FSGS.

"Focal Segmental Glomerulosclerosis- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Focal Segmental Glomerulosclerosis pipeline landscape is provided which includes the disease overview and Focal Segmental Glomerulosclerosis treatment guidelines. The assessment part of the report embraces, in depth Focal Segmental Glomerulosclerosis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Focal Segmental Glomerulosclerosis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights:

• The companies and academics are working to assess challenges and seek opportunities that could influence Focal Segmental Glomerulosclerosis R&D. The therapies under development are focused on novel approaches to treat/improve Focal Segmental Glomerulosclerosis.

Focal Segmental Glomerulosclerosis Emerging Drugs Chapters

This segment of the Focal Segmental Glomerulosclerosis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Focal Segmental Glomerulosclerosis Emerging Drugs

• Sparsentan: Travere Therapeutics

Sparsentan, a Dual Endothelin Angiotensin Receptor Antagonist (DEARA), is a novel investigational product candidate selectively targeting the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R). Pre-clinical data have shown that blockade of both endothelin type A and angiotensin II type 1 pathways in forms of rare chronic kidney disease reduces proteinuria, protects podocytes, and prevents glomerulosclerosis and mesangial cell proliferation. The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted sparsentan orphan drug designation for FSGS. In March 2025, Travere Therapeutics announced that the US Food and Drug Administration has accepted its supplemental New Drug Application (sNDA) for traditional approval of FILSPARI (sparsentan) for the treatment of focal segmental glomerulosclerosis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026, and has indicated that it is currently planning to hold an advisory committee meeting to discuss the application.

• DMX-200: Dimerix Bioscience

DMX-200 is a chemokine receptor (CCR2) blocker and is administered to patients taking an angiotensin II type I (AT1) receptor blocker (ARB), which is the standard of care treatment for focal segmental glomerulosclerosis. DMX-200 has been granted patents in various territories until 2032 and has also been granted Orphan Drug Designation by the FDA and EMA.

In 2020, DMX-200 demonstrated clear benefit to patients with FSGS in its first Phase IIa study in patients specifically with FSGS, following several successful studies in patients with a range of Chronic Kidney Diseases. All trial endpoints were achieved, and DMX-200 was determined to be safe and tolerable. DMX-200 is currently in a Phase III clinical trial for the treatment of FSGS.

• WAL0921: Walden Biosciences

WAL0921 is Walden's first-in-class, proprietary, humanized monoclonal antibody that binds soluble urokinase plasminogen activator receptor (suPAR) and inhibits the pathological activity of suPAR that causes podocyte dysfunction and kidney disease. It is an Anti-suPAR antibody targeting suPAR, a pro-inflammatory protein that initiates and aggravates kidney disease. suPAR is the soluble, circulating form of the urokinase plasminogen activator receptor (uPAR). suPAR is a protein that is present in healthy individuals but elevated in those with CKD. Several studies have shown that elevated suPAR levels cause kidney disease progression by activating a signaling cascade which leads to podocyte injury. Preventing this interaction in animals using anti-suPAR antibodies or through a process called plasmapheresis, in individuals with recurrent FSGS, has shown that kidney disease progression can be slowed or halted by the removal of suPAR. Currently, the drug is in Phase II stage of its development for the treatment of Focal Segmental Glomerulosclerosis.

Focal Segmental Glomerulosclerosis: Therapeutic Assessment

This segment of the report provides insights about the different Focal Segmental Glomerulosclerosis drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Focal Segmental Glomerulosclerosis

There are approx. 15+ key companies which are developing the therapies for Focal Segmental Glomerulosclerosis. The companies which have their Focal Segmental Glomerulosclerosis drug candidates in the most advanced stage, i.e. Registered include, Travere Therapeutics.

• Phases

DelveInsight's report covers around 18+ products under different phases of clinical development like

• 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
• Route of Administration

Focal Segmental Glomerulosclerosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Intramuscular
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Focal Segmental Glomerulosclerosis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Focal Segmental Glomerulosclerosis therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Focal Segmental Glomerulosclerosis drugs.

Focal Segmental Glomerulosclerosis Report Insights

• Focal Segmental Glomerulosclerosis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Focal Segmental Glomerulosclerosis Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Focal Segmental Glomerulosclerosis drugs?
• How many Focal Segmental Glomerulosclerosis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Focal Segmental Glomerulosclerosis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Focal Segmental Glomerulosclerosis therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Focal Segmental Glomerulosclerosis and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Dimerix Bioscience
• Travere Therapeutics
• Pfizer
• Goldfinch Bio

Key Products

• DMX-200
• Sparsentan
• PF-06730512
• GFB-887