Alpha-1 Antitrypsin Deficiency Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies by DelveInsight
DelveInsight's, ' Alpha 1 Antitrypsin Deficiency Pipeline Insight ' report provides comprehensive insights about 12+ companies and 12+ pipeline drugs in Alpha 1 Antitrypsin Deficiency pipeline landscape. It covers the Alpha 1 Antitrypsin Deficiency pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Alpha 1 Antitrypsin Deficiency therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive Alpha 1 Antitrypsin Deficiency pipeline products in this space.
Stay ahead with the latest insights! Download DelveInsight's comprehensive Alpha 1 Antitrypsin Deficiency Pipeline Report to explore emerging therapies, key Alpha 1 Antitrypsin Deficiency Companies, and future Alpha 1 Antitrypsin Deficiency treatment landscapes @ Alpha 1 Antitrypsin Deficiency Pipeline Outlook Report
Key Takeaways from the Alpha 1 Antitrypsin Deficiency Pipeline Report
In February 2025:- Grifols Therapeutics Inc.:- The purpose of this study is to evaluate the safety and tolerability of 72 milligrams per kilogram (mg/kg) and 180 mg/kg Alpha-1 15%, administered as a single-dose subcutaneous (SC) infusion and subsequently as weekly SC infusions over 8 weeks in participants with Alpha1-Antitrypsin Deficiency (AATD).
In January 2025:- Takeda:- The liver produces a protein called alpha-1 antitrypsin (AAT). AAT is normally released into the bloodstream. In some people, the liver makes an abnormal version of the AAT protein, called Z-AAT. Making an abnormal version of the AAT protein can result in liver disease as Z-AAT builds up in liver cells, which leads to liver problems such as liver scarring (fibrosis), continuing liver damage (cirrhosis), and eventually endstage liver disease.
In January 2025:- Korro Bio Inc.:- The purpose of this first-in human (FIH) study is to assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple doses of KRRO-110 in both healthy adult participants and in clinically stable patients with Alpha-1 antitrypsin deficiency (AATD).
In January 2025:- Arrowhead Pharmaceuticals: - The purpose of AROAAT2001 (SEQUOIA) is to evaluate the safety, efficacy and tolerability of multiple doses of the investigational product, Fazirsiran Injection, administered subcutaneously to participants with alpha-1 antitrypsin deficiency (AATD).
In January 2025:- Kamada Ltd:- The goal of this clinical trial is to learn if AAT for inhalation, at a dose of 80 mg/day can slow the progression of lung disease in people who have lung disease caused by severe genetic deficiency in Alpha 1 Antitrypsin (AATD).
DelveInsight's Alpha 1 Antitrypsin Deficiency pipeline report depicts a robust space with 12+ active players working to develop 12+ pipeline therapies for Alpha 1 Antitrypsin Deficiency treatment.
The leading Alpha 1 Antitrypsin Deficiency Companies such as Octapharma, Dicerna Pharmaceuticals, Alnylam Pharmaceuticals, Arrowhead Pharmaceuticals, Vertex Pharmaceuticals, AstraZeneca, Kamada Ltd and others.
Promising Alpha-1 Antitrypsin Deficiency Pipeline Therapies such as Fazirsiran Injection, Aerosolized, Recombinant Alpha 1-Antitrypsin, INBRX-101/rhAAT-Fc, ADVM-043, and others.
Discover how the Alpha 1 Antitrypsin Deficiency treatment paradigm is evolving. Access DelveInsight's in-depth Alpha 1 Antitrypsin Deficiency Pipeline Analysis for a closer look at promising breakthroughs @ Alpha 1 Antitrypsin Deficiency Clinical Trials and Studies
Alpha 1 Antitrypsin Deficiency Emerging Drugs Profile
ARO AAT: Arrowhead Pharmaceuticals
ARO AAT is a second generation, N-Acetylgalactosamine (GalNAc) based, subcutaneously administered RNA interference based therapeutic. ARO-AAT is designed to knock down the hepatic production of the mutant alpha-1 antitrypsin (Z-AAT) protein, the cause of progressive liver disease in AATD patients. In June 2019, the US FDA has granted Fast Track designation to ARO-AAT. ARO-AAT is in Phase III clinical studies for the treatment of liver disease associated with alpha-1 antitrypsin deficiency (AATD).
ALN-AAT02: Alnylam Pharmaceuticals
ALN AAT02 is a subcutaneously administered RNAi therapeutic that targets alpha-1 antitrypsin (AAT). ALN-AAT02 is based on the Alnylam's enhanced stabilization chemistry plus (ESC+)-GalNAc-conjugate technology, which enables subsequent subcutaneous dosing with increased selectivity and a wide therapeutic index. The drug is currently in Phase I/II clinical development for the treatment of ZZ Type AAT Deficiency Liver Disease.
The Alpha 1 Antitrypsin Deficiency pipeline report provides insights into
The report provides detailed insights about companies that are developing therapies for the treatment of Alpha 1 Antitrypsin Deficiency 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 Alpha 1 Antitrypsin Deficiency Treatment.
Alpha 1 Antitrypsin Deficiency Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
Alpha 1 Antitrypsin Deficiency 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 Alpha 1 Antitrypsin Deficiency market.
Get a detailed analysis of the latest innovations in the Alpha 1 Antitrypsin Deficiency pipeline. Explore DelveInsight's expert-driven report today! @ Alpha 1 Antitrypsin Deficiency Unmet Needs
Alpha 1 Antitrypsin Deficiency Companies
Octapharma, Dicerna Pharmaceuticals, Alnylam Pharmaceuticals, Arrowhead Pharmaceuticals, Vertex Pharmaceuticals, AstraZeneca, Kamada Ltd and others.
Alpha 1 Antitrypsin Deficiency pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
Intra-articular
Intraocular
Intrathecal
Intravenous
Ophthalmic
Oral
Parenteral
Subcutaneous
Topical
Transdermal
Alpha 1 Antitrypsin Deficiency Products have been categorized under various Molecule types such as
Oligonucleotide
Peptide
Small molecule
Download DelveInsight's latest report to gain strategic insights into upcoming Alpha 1 Antitrypsin Deficiency Therapies and key Alpha 1 Antitrypsin Deficiency Developments @ Alpha 1 Antitrypsin Deficiency Market Drivers and Barriers, and Future Perspectives
Scope of the Alpha 1 Antitrypsin Deficiency Pipeline Report
Coverage- Global
Alpha 1 Antitrypsin Deficiency Companies- Octapharma, Dicerna Pharmaceuticals, Alnylam Pharmaceuticals, Arrowhead Pharmaceuticals, Vertex Pharmaceuticals, AstraZeneca, Kamada Ltd and others.
Alpha-1 Antitrypsin Deficiency Pipeline Therapies - Fazirsiran Injection, Aerosolized, Recombinant Alpha 1-Antitrypsin, INBRX-101/rhAAT-Fc, ADVM-043, and others.
Alpha 1 Antitrypsin Deficiency Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
Alpha 1 Antitrypsin Deficiency Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Which companies are leading the race in Alpha 1 Antitrypsin Deficiency drug development? Find out in DelveInsight's exclusive Alpha 1 Antitrypsin Deficiency Pipeline Report—access it now! @ Alpha 1 Antitrypsin Deficiency Emerging Drugs and Major Companies
Table of Content
Introduction
Alpha-1 Antitrypsin Deficiency Executive Summary
Alpha-1 Antitrypsin Deficiency: Overview
Alpha-1 Antitrypsin Deficiency Pipeline Therapeutics
Alpha-1 Antitrypsin Deficiency Pipeline Therapeutic Assessment
Alpha-1 Antitrypsin Deficiency– DelveInsight's Analytical Perspective
Late Stage Products (Phase III)
ARO AAT: Arrowhead Pharmaceuticals
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
Drug Name: Company Name
Drug profiles in the detailed report…..
Early Stage Products (Phase I/II)
ALN-AAT02: Alnylam Pharmaceuticals
Drug profiles in the detailed report…..
Preclinical and Discovery Stage Products
Drug Name: Company Name
Drug profiles in the detailed report…..
Inactive Products
Alpha-1 Antitrypsin Deficiency Key Companies
Alpha-1 Antitrypsin Deficiency Key Products
Alpha-1 Antitrypsin Deficiency- Unmet Needs
Alpha-1 Antitrypsin Deficiency- Market Drivers and Barriers
Alpha-1 Antitrypsin Deficiency- Future Perspectives and Conclusion
Alpha-1 Antitrypsin Deficiency Analyst Views
Alpha-1 Antitrypsin Deficiency Key Companies
Appendix
About Us
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
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Globe and Mail
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Globe and Mail
13-05-2025
- Globe and Mail
Visterra, Chinook Therapeutics, Novartis, IgA proteases Selecta Biosciences, Shanghai Alebund Pharmaceuticals
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The total market size for the EU4 and the UK was estimated at around USD 150 million in 2024, representing nearly 21% of the overall market revenue for the 7MM, with growth expected by 2034. In 2024, Germany led the IgAN market among the EU4 and the UK with approximately USD 45 million in revenue, followed by France at around USD 35 million and Italy at nearly USD 30 million. In 2024, Japan's IgAN market size was estimated at around USD 125 million, with expectations of growth throughout the forecast period from 2025 to 2034. DelveInsight estimates that around 415,000 prevalent cases of IgA Nephropathy (IgAN) were reported across the 7MM in 2024. These diagnosed cases are expected to grow at a CAGR of 0.6% by 2034. In 2024, the United States reported approximately 133,000 diagnosed prevalent cases of IgA Nephropathy (IgAN), with numbers expected to rise by 2034. 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The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends. IgA Nephropathy Epidemiology Segmentation: The IgA Nephropathy market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalence of IgA Nephropathy Prevalent Cases of IgA Nephropathy by severity Gender-specific Prevalence of IgA Nephropathy Diagnosed Cases of Episodic and Chronic IgA Nephropathy Download the report to understand which factors are driving IgA Nephropathy epidemiology trends @ IgA Nephropathy Epidemiology Forecast IgA Nephropathy Drugs Uptake and Pipeline Development Activities The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the IgA Nephropathy market or expected to get launched during the study period. The analysis covers IgA Nephropathy market uptake by drugs, patient uptake by therapies, and sales of each drug. Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share. The report also covers the IgA Nephropathy Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies. IgA Nephropathy Therapies and Key Companies VANRAFIA (atrasentan): Novartis FILSPARI (sparsentan): Travere Therapeutics TARPEYO/KINPEYGO (budesonide): Asahi Kasei (Calliditas Therapeutics) Povetacicept (ALPN-303): Vertex Pharmaceuticals Atacicept: Vera Therapeutics Zigakibart (FUB523): Novartis Sibeprenlimab: Visterra Atrasentan: Chinook Therapeutics LNP023: Novartis Pharmaceuticals Research programme: IgA proteases Selecta Biosciences AP 305: Shanghai Alebund Pharmaceuticals ADR-001: Rohto Pharmaceutical MY 008: Wuhan Createrna Science and Technology SHR-2010: Guangdong Hengrui Pharmaceutical IONIS FB: LRx Ionis Pharmaceuticals HR19042: Jiangsu HengRui Medicine Co., Ltd. Sparsentan: Travere Therapeutics HR19042: Jiangsu HengRui Medicine Co., Ltd. Discover more about therapies set to grab major IgA Nephropathy market share @ IgA Nephropathy Treatment Landscape IgA Nephropathy Market Drivers Increase in prevalence of IgA Nephropathy (IgAN), increment in the number of government initiatives to spread awareness are some of the important factors that are fueling the IgA Nephropathy Market. IgA Nephropathy Market Barriers However, lack of in-depth understanding of the disease pathogenesis, the unreported and undiagnosed IgA Nephropathy cases and other factors are creating obstacles in the IgA Nephropathy Market growth. Scope of the IgA Nephropathy Market Report Study Period: 2020–2034 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key IgA Nephropathy Companies: Travere Therapeutics, Asahi Kasei (Calliditas Therapeutics), Vertex Pharmaceuticals, Vera Therapeutics, Visterra, Chinook Therapeutics, Novartis, IgA proteases Selecta Biosciences, Shanghai Alebund Pharmaceuticals, Rohto Pharmaceutical, Wuhan Createrna Science and Technology, Guangdong Hengrui Pharmaceutical, LRx Ionis Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Travere Therapeutics, and others Key IgA Nephropathy Therapies: VANRAFIA (atrasentan), FILSPARI (sparsentan), TARPEYO/KINPEYGO (budesonide), Povetacicept (ALPN-303), Atacicept, Zigakibart (FUB523), Sibeprenlimab, Atrasentan, LNP023, Research programme, AP 305, ADR-001, MY 008, SHR-2010, IONIS FB, HR19042, Sparsentan, HR19042, and others IgA Nephropathy Therapeutic Assessment: IgA Nephropathy current marketed and IgA Nephropathy emerging therapies IgA Nephropathy Market Dynamics: IgA Nephropathy market drivers and IgA Nephropathy market barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies IgA Nephropathy Unmet Needs, KOL's views, Analyst's views, IgA Nephropathy Market Access and Reimbursement Table of Contents 1. IgA Nephropathy Market Report Introduction 2. Executive Summary for IgA Nephropathy 3. SWOT analysis of IgA Nephropathy 4. IgA Nephropathy Patient Share (%) Overview at a Glance 5. IgA Nephropathy Market Overview at a Glance 6. IgA Nephropathy Disease Background and Overview 7. IgA Nephropathy Epidemiology and Patient Population 8. Country-Specific Patient Population of IgA Nephropathy 9. IgA Nephropathy Current Treatment and Medical Practices 10. IgA Nephropathy Unmet Needs 11. IgA Nephropathy Emerging Therapies 12. IgA Nephropathy Market Outlook 13. Country-Wise IgA Nephropathy Market Analysis (2020–2034) 14. IgA Nephropathy Market Access and Reimbursement of Therapies 15. IgA Nephropathy Market Drivers 16. IgA Nephropathy Market Barriers 17. IgA Nephropathy Appendix 18. IgA Nephropathy Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. 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