Alport Syndrome Clinical, Companies, Therapeutic Assessment, Therapies, Treatment Algorithm, Pipeline Analysis | Enyo Pharma, Bayer

Alport Syndrome Pipeline constitutes 4+ key companies continuously working towards developing 6+ Alport Syndrome treatment therapies, analyzes DelveInsight.

Alport Syndrome Overview:

Alport syndrome is a rare inherited disorder, affecting approximately 1 in 50,000 people, and is most often characterized by microscopic hematuria and progressive chronic kidney disease (CKD), along with complications beyond the kidneys. The condition arises from mutations in the COL4A3, COL4A4, and COL4A5 genes, which interfere with the normal assembly of the α3-α4-α5 collagen IV network. Early manifestations such as hematuria, proteinuria, and edema are nonspecific, making it challenging to distinguish the disease from other kidney disorders, often leading to misdiagnosis.

The clinical features primarily involve the kidneys, hearing, and eyes. Kidney symptoms usually begin with blood in the urine, detectable either visibly or microscopically, and progress to proteinuria as renal function declines, frequently advancing to CKD or end-stage renal disease. Sensorineural hearing loss, a hallmark of the condition, typically emerges in childhood or adolescence and worsens over time. Ocular changes, including lens abnormalities like anterior lenticonus and retinal defects, may also occur, though their impact on vision is generally less severe compared to kidney and hearing issues.

At the molecular level, Alport syndrome stems from mutations in type IV collagen genes, disrupting a structural protein critical for the basement membranes of the kidneys, inner ear, and eyes. These genetic defects compromise the glomerular basement membrane, causing thinning, splitting, and scarring that impair filtration and result in blood and protein leakage in the urine. In the inner ear, defective collagen disrupts cochlear function, leading to progressive sensorineural hearing loss, while in the eyes, structural changes contribute to characteristic but usually less debilitating visual problems.

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"Alport Syndrome Pipeline Insight 2025" report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the Alport Syndrome Therapeutics Market.

Key Takeaways from the Alport Syndrome Pipeline Report

DelveInsight's Alport Syndrome pipeline report depicts a robust space with 4+ active players working to develop 6+ pipeline therapies for Alport Syndrome treatment.
In January 2024, Enyo Pharma received FDA clearance for the Investigational New Drug (IND) application to launch a Phase II trial (ALPESTRIA-1) of Vonafexor in Alport syndrome patients.
Key Alport Syndrome companies such as Enyo Pharma, Bayer, and others are evaluating new drugs for Alport Syndrome to improve the treatment landscape.
Promising Alport Syndrome pipeline therapies in various stages of development include Vonafexor, BAY 3401016, and others.

Alport Syndrome Pipeline Analysis
The report provides insights into:
The report provides detailed insights into the key companies that are developing therapies in the Alport Syndrome Market.
The report also evaluates different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Alport Syndrome treatment.
It analyzes the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
It navigates the emerging drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement, and financing details for future advancement of the Alport Syndrome market.

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Alport Syndrome Emerging Drugs

Vonafexor - Enyo Pharma

Vonafexor (EYP001) is an investigational therapy from Enyo Pharma aimed at treating kidney-related disorders such as Alport syndrome and chronic kidney disease (CKD). It is a synthetic, non-steroidal, non-bile acid farnesoid X receptor (FXR) agonist, notable for its high selectivity toward FXR with no activity on the bile acid receptor TGR5. Unlike other FXR agonists, Vonafexor's unique structure drives a distinct gene expression profile depending on ligand-binding patterns. The drug is currently undergoing Phase II clinical trials for Alport syndrome.
BAY 3401016 - Bayer

BAY 3401016, also referred to as SEMA 3A, is a monoclonal antibody developed by Bayer in partnership with Evotec SE. It inhibits semaphorin 3A (SEMA3A), a protein involved in neuronal signaling and immune regulation. The candidate is in Phase I clinical development for Alport syndrome.

Alport Syndrome Companies

Approximately four or more key companies are actively working on developing therapies for Alport Syndrome. Among them, Enyo Pharma has a drug candidate that is currently in the most advanced stage of development (Phase II).

DelveInsight's report covers around 75+ 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

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

Intravenous
Subcutaneous
Oral
Intramuscular

Alport Syndrome Products have been categorized under various Molecule types such as

Monoclonal antibody
Small molecule
Peptide

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Alport Syndrome Pipeline Therapeutic Assessment
• Alport Syndrome Assessment by Product Type
• Alport Syndrome By Stage
• Alport Syndrome Assessment by Route of Administration
• Alport Syndrome Assessment by Molecule Type

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