“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:
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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
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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.
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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.
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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:
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Eculizumab: Alexion Pharmaceuticals
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Crovalimab: Hoffmann-La Roche
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Iptacopan: Novartis
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NM8074: NovelMed Therapeutics
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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
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Oral
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Parenteral
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Intravenous
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Subcutaneous
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Topical
Molecule Type
Products have been categorized under various Molecule types, such as
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Monoclonal Antibody
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Peptides
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Polymer
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Small molecule
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Gene therapy
Atypical Hemolytic Uremic Syndrome Pipeline Therapeutics Assessment
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Atypical Hemolytic Uremic Syndrome Assessment by Product Type
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Atypical Hemolytic Uremic Syndrome By Stage and Product Type
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Atypical Hemolytic Uremic Syndrome Assessment by Route of Administration
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Atypical Hemolytic Uremic Syndrome By Stage and Route of Administration
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Atypical Hemolytic Uremic Syndrome Assessment by Molecule Type
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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
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Late-stage products (Phase III)
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Mid-stage products (Phase II)
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Early-stage product (Phase I)
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Pre-clinical and Discovery stage candidates
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Discontinued & Inactive candidates
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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.
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Atypical Hemolytic Uremic Syndrome Pipeline Analysis:
The Atypical Hemolytic Uremic Syndrome pipeline report provides insights into
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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.
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It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Atypical Hemolytic Uremic Syndrome Treatment.
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Atypical Hemolytic Uremic Syndrome key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
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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.
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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
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Increasing prevalence due to improved survival
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Rising awareness of aHUS
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Good emerging pipeline assets driving the R&D
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Changing scenario in treatment landscape
Atypical Hemolytic Uremic Syndrome Pipeline Market Barriers
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Lack of definite diagnosis criteria
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Upcoming biosimilars in the market
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Challenges in clinical trials
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Premium pricing of the drugs has resulted in low commercial uptake
Scope of Atypical Hemolytic Uremic Syndrome Pipeline Drug Insight
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Coverage: Global
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Key Atypical Hemolytic Uremic Syndrome Companies: Alexion Pharmaceuticals, Hoffmann-La Roche, Novartis, NovelMed Therapeutics, and others
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Key Atypical Hemolytic Uremic Syndrome Therapies: Eculizumab, Crovalimab, Iptacopan, NM8074, Ravulizumab, and others
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Atypical Hemolytic Uremic Syndrome Therapeutic Assessment: Atypical Hemolytic Uremic Syndrome current marketed and Atypical Hemolytic Uremic Syndrome emerging therapies
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Atypical Hemolytic Uremic Syndrome Market Dynamics: Atypical Hemolytic Uremic Syndrome market drivers and Atypical Hemolytic Uremic Syndrome market barriers
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Table of Contents
| 1 | Atypical Hemolytic Uremic Syndrome Report Introduction |
| 2 | Atypical Hemolytic Uremic Syndrome Executive Summary |
| 3 | Atypical Hemolytic Uremic Syndrome Overview |
| 4 | Atypical Hemolytic Uremic Syndrome- Analytical Perspective In-depth Commercial Assessment |
| 5 | Atypical Hemolytic Uremic Syndrome Pipeline Therapeutics |
| 6 | Atypical Hemolytic Uremic Syndrome Late Stage Products (Phase II/III) |
| 7 | Atypical Hemolytic Uremic Syndrome Mid Stage Products (Phase II) |
| 8 | Atypical Hemolytic Uremic Syndrome Early Stage Products (Phase I) |
| 9 | Atypical Hemolytic Uremic Syndrome Preclinical Stage Products |
| 10 | Atypical Hemolytic Uremic Syndrome Therapeutics Assessment |
| 11 | Atypical Hemolytic Uremic Syndrome Inactive Products |
| 12 | Company-University Collaborations (Licensing/Partnering) Analysis |
| 13 | Atypical Hemolytic Uremic Syndrome Key Companies |
| 14 | Atypical Hemolytic Uremic Syndrome Key Products |
| 15 | Atypical Hemolytic Uremic Syndrome Unmet Needs |
| 16 | Atypical Hemolytic Uremic Syndrome Market Drivers and Barriers |
| 17 | Atypical Hemolytic Uremic Syndrome Future Perspectives and Conclusion |
| 18 | Atypical Hemolytic Uremic Syndrome Analyst Views |
| 19 | Appendix |
| 20 | About DelveInsight |
*The Table of Contents (TOC) is not exhaustive; the final content may vary. Refer to the sample report for the complete table of contents.
About DelveInsight
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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