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Las Vega (Nevada), United States //- As per DelveInsight's assessment, globally, Atypical Hemolytic Uremic Syndrome pipeline constitutes 5+ key companies continuously working towards developing 5+ Atypical Hemolytic Uremic Syndrome treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.
“Atypical Hemolytic Uremic Syndrome Pipeline Insight, 2025 " report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Atypical Hemolytic Uremic Syndrome Market.
The Atypical Hemolytic Uremic Syndrome Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.
Some of the key takeaways from the Atypical Hemolytic Uremic Syndrome Pipeline Report:
Companies across the globe are diligently working toward developing novel Atypical Hemolytic Uremic Syndrome treatment therapies with a considerable amount of success over the years. Atypical Hemolytic Uremic Syndrome Key players such as - Alexion Pharmaceuticals, Hoffmann-La Roche, Novartis, NovelMed Therapeutics, and others, are developing therapies for the Atypical Hemolytic Uremic Syndrome treatment
Atypical Hemolytic Uremic Syndrome Emerging therapies such as - Eculizumab, Crovalimab, Iptacopan, NM8074, Ravulizumab, and others are expected to have a significant impact on the Atypical Hemolytic Uremic Syndrome market in the coming years.
In June 2025, Novartis reported positive findings from APPULSE-PNH, a Phase IIIB trial assessing the efficacy and safety of twice-daily oral monotherapy Fabhalta® (iptacopan) in adults with paroxysmal nocturnal hemoglobinuria (PNH) who had hemoglobin levels ≥10 g/dL and transitioned from anti-C5 therapies (eculizumab or ravulizumab). After 24 weeks, Fabhalta treatment led to an average hemoglobin increase of 2.01 g/dL (95% CI, 1.74–2.29), with most patients reaching normal or near-normal levels. These results will be shared at the European Hematology Association (EHA) Congress 2025. Beyond PNH, Fabhalta is being investigated in several rare kidney disorders, including atypical hemolytic uremic syndrome (aHUS), immune complex membranoproliferative glomerulonephritis (IC-MPGN), and lupus nephritis (LN), with ongoing studies evaluating safety, efficacy, and potential for regulatory approvals.
In April 2025, Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), along with Samsung Bioepis Co., Ltd., announced the U.S. launch of EPYSQLI® (eculizumab-aagh). EPYSQLI, a biosimilar to Soliris® (eculizumab), is approved for treating paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive. Priced at a 30% lower Wholesale Acquisition Cost (WAC) than Soliris®, EPYSQLI represents one of the most cost-effective biosimilar alternatives to Soliris® in the U.S.
Atypical Hemolytic Uremic Syndrome Overview
Atypical Hemolytic Uremic Syndrome (aHUS) is a rare, life-threatening disease characterized by the abnormal activation of the complement system, part of the immune system. This leads to the destruction of red blood cells (hemolysis), low platelet counts (thrombocytopenia), and damage to small blood vessels, particularly in the kidneys, causing kidney failure. Unlike typical HUS, which is often triggered by infections such as E. coli, aHUS is usually caused by genetic mutations or autoimmune factors affecting complement regulation. Early diagnosis and targeted therapies, such as complement inhibitors, are crucial to prevent organ damage and improve outcomes.
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Emerging Atypical Hemolytic Uremic Syndrome Drugs Under Different Phases of Clinical Development Include:
Eculizumab: Alexion Pharmaceuticals
Crovalimab: Hoffmann-La Roche
Iptacopan: Novartis
NM8074: NovelMed Therapeutics
Ravulizumab: Alexion Pharmaceuticals
Route of Administration
Atypical Hemolytic Uremic 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
Oral
Parenteral
Intravenous
Subcutaneous
Topical
Molecule Type
Products have been categorized under various Molecule types, such as
Monoclonal Antibody
Peptides
Polymer
Small molecule
Gene therapy
Atypical Hemolytic Uremic Syndrome Pipeline Therapeutics Assessment
Atypical Hemolytic Uremic Syndrome Assessment by Product Type
Atypical Hemolytic Uremic Syndrome By Stage and Product Type
Atypical Hemolytic Uremic Syndrome Assessment by Route of Administration
Atypical Hemolytic Uremic Syndrome By Stage and Route of Administration
Atypical Hemolytic Uremic Syndrome Assessment by Molecule Type
Atypical Hemolytic Uremic Syndrome by Stage and Molecule Type
DelveInsight's Atypical Hemolytic Uremic Syndrome Report covers around 5+ products under different phases of clinical development like
Late-stage products (Phase III)
Mid-stage products (Phase II)
Early-stage product (Phase I)
Pre-clinical and Discovery stage candidates
Discontinued & Inactive candidates
Route of Administration
Some of the key companies in the Atypical Hemolytic Uremic Syndrome Therapeutics Market include:
Key companies developing therapies for Atypical Hemolytic Uremic Syndrome treatment are - Alexion Pharmaceuticals (a subsidiary of AstraZeneca), Apellis Pharmaceuticals, Novartis, Achillion Pharmaceuticals (a subsidiary of Alexion Pharmaceuticals), Omeros Corporation, Ra Pharmaceuticals (now part of UCB), Regeneron Pharmaceuticals, Chugai Pharmaceutical, and others.
Download Sample PDF Report to know more about Atypical Hemolytic Uremic Syndrome drugs and therapies
Atypical Hemolytic Uremic Syndrome Pipeline Analysis:
The Atypical Hemolytic Uremic Syndrome pipeline report provides insights into
The report provides detailed insights about companies that are developing therapies for the treatment of Atypical Hemolytic Uremic Syndrome with aggregate therapies developed by each company for the same.
It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Atypical Hemolytic Uremic Syndrome Treatment.
Atypical Hemolytic Uremic Syndrome key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
Atypical Hemolytic Uremic Syndrome 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 Atypical Hemolytic Uremic Syndrome market.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.
Further Atypical Hemolytic Uremic Syndrome product details are provided in the report. Download the Atypical Hemolytic Uremic Syndrome pipeline report to learn more about the emerging Atypical Hemolytic Uremic Syndrome therapies
Atypical Hemolytic Uremic Syndrome Pipeline Market Drivers
Increasing prevalence due to improved survival
Rising awareness of aHUS
Good emerging pipeline assets driving the R&D
Changing scenario in treatment landscape
Atypical Hemolytic Uremic Syndrome Pipeline Market Barriers
Lack of definite diagnosis criteria
Upcoming biosimilars in the market
Challenges in clinical trials
Premium pricing of the drugs has resulted in low commercial uptake
Scope of Atypical Hemolytic Uremic Syndrome Pipeline Drug Insight
Coverage: Global
Key Atypical Hemolytic Uremic Syndrome Companies: Alexion Pharmaceuticals, Hoffmann-La Roche, Novartis, NovelMed Therapeutics, and others
Key Atypical Hemolytic Uremic Syndrome Therapies: Eculizumab, Crovalimab, Iptacopan, NM8074, Ravulizumab, and others
Atypical Hemolytic Uremic Syndrome Therapeutic Assessment: Atypical Hemolytic Uremic Syndrome current marketed and Atypical Hemolytic Uremic Syndrome emerging therapies
Atypical Hemolytic Uremic Syndrome Market Dynamics: Atypical Hemolytic Uremic Syndrome market drivers and Atypical Hemolytic Uremic Syndrome market barriers
Request for Sample PDF Report for Atypical Hemolytic Uremic Syndrome Pipeline Assessment and clinical trials
Table of Contents
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.
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