DelveInsight’s, “Hemophilia A Pipeline Insights 2025” report provides comprehensive insights about 40+ companies and 40+ pipeline drugs in the Hemophilia A pipeline landscape. It covers the Hemophilia A pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Hemophilia A pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
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Key Takeaways from the Hemophilia A Pipeline Report
- In July 2025, CSL Behring conducted a study in China is to investigate the pharmacokinetics (PK) of rVIII-SingleChain after an initial and repeat dose and to assess efficacy and safety during 2 to 3 times weekly prophylaxis treatment with rVIII-SingleChain in male Chinese PTPs with severe hemophilia A (FVIII activity less than [<] 1%).
- In July 2025, Novo Nordisk A/S announced a study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector.
- In July 2025, Hoffmann-La Roche announced a Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A.
- DelveInsight’s Hemophilia A pipeline report depicts a robust space with 40+ active players working to develop 40+ pipeline therapies for Hemophilia A treatment.
- The leading Hemophilia A Companies such as Hoffmann-La Roche, Chugai Pharmaceutical, Shire, Pfizer, BioMarin Pharmaceutical, Sinocelltech Ltd., Bayer, Ultragenyx Pharmaceutical, Spark Therapeutics, Octapharma, ApcinteX Ltd., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Expression Therapeutics, LLC, CSL Behring and others.
- Promising Hemophilia A Pipeline Therapies such as Emicizumab, rFVIIa, aPCC, BAX 888, OBIZUR, BIIB031 (rFVIIIFc), Recombinant Human Coagulation FVIII, and others.
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Hemophilia A Emerging Drugs Profile
- AGN-193408: Allergan
Allergan is conducting a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-group (Cohort 2) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension. It is an implant containing preservative-free AGN-193408 dispersed in a biodegradable polymer matrix.
- OCTA101: Octapharma
Octapharma is evaluating OCTA101 (a human-cl rhFVIII and recombinant human von Willebrand Factor fragment dimer) under a Phase 1/2 study, which will be a dose escalation study in adults in 5 cohorts, with the main purpose to assess the safety of subcutaneous injection of OCTA101 (in previously treated adult patients with severe hemophilia A. The study also aims to assess the pharmacokinetics (PK) characteristics, dose proportionality, and subcutaneous bioavailability of OCTA101 compared with intravenous administration of Nuwiq (Human-cl rh FVIII), in order to define the prophylactic treatment (dose and injection interval) that would result in protective trough levels of FVIII:C for future Phase 3 studies. By Data Monitoring Committee recommendation, patients enrolled in cohorts 1, 2 and 3 will proceed to 3-month prophylactic treatment to receive daily dosing of OCTA101 for 3 months.
- Valoctocogene roxaparvovec: BioMarin Pharmaceuticals
Valoctocogene roxaparvovec, is an investigational gene therapy in clinical trials for the treatment of Hemophilia A and has not been determined to be safe or effective. Valoctocogene roxaparvovec is administered as a single infusion. The ongoing clinical trials will determine if the new gene will enable the body to produce factor VIII. Following infusion, clinical trial subjects are being evaluated to determine the safety profile, changes in Factor VIII activity levels, changes in factor replacement usage, changes in reported bleeds requiring factor replacement, and quality of life measures, among other endpoints.
The Hemophilia A Pipeline Report Provides Insights into
- The report provides detailed insights about companies that are developing therapies for the treatment of Hemophilia A 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 Hemophilia A Treatment.
- Hemophilia A Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
- Hemophilia A 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 Hemophilia A market
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Hemophilia A Companies
Hoffmann-La Roche, Chugai Pharmaceutical, Shire, Pfizer, BioMarin Pharmaceutical, Sinocelltech Ltd., Bayer, Ultragenyx Pharmaceutical, Spark Therapeutics, Octapharma, ApcinteX Ltd., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Expression Therapeutics, LLC, CSL Behring and others.
Hemophilia A 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
- Molecule Type
Hemophilia A Products have been categorized under various Molecule types such as
- Small molecules
- Gene Therapies
- Bispecific antibodies
- Recombinant proteins
- Fusion Proteins
- Coagulants
- Blood coagulation factor replacements
Unveil the future of Hemophilia A Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ Hemophilia A Market Drivers and Barriers
Scope of the Hemophilia A Pipeline Report
- Coverage- Global
- Hemophilia A Companies- Hoffmann-La Roche, Chugai Pharmaceutical, Shire, Pfizer, BioMarin Pharmaceutical, Sinocelltech Ltd., Bayer, Ultragenyx Pharmaceutical, Spark Therapeutics, Octapharma, ApcinteX Ltd., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Expression Therapeutics, LLC, CSL Behring and others.
- Hemophilia A Pipeline Therapies- Emicizumab, rFVIIa, aPCC, BAX 888, OBIZUR, BIIB031 (rFVIIIFc), Recombinant Human Coagulation FVIII, and others.
- Hemophilia A Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
- Hemophilia A Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
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Table of Contents
- Introduction
- Executive Summary
- Hemophilia A: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Hemophilia A – DelveInsight’s Analytical Perspective
- In-depth Commercial Assessment
- Hemophilia A Collaboration Deals
- Late Stage Products (Pre-registration)
- Valoctocogene roxaparvovec: BioMarin Pharmaceutical
- Late Stage Products (Phase III)
- Giroctocogene fitelparvovec: Pfizer/ Sangamo Therapeutics
- Mid Stage Products (Phase II)
- Comparative Analysis
- NNC0365-3769 A (Mim8): Novo Nordisk A/S
- Early Stage Products (Phase I/II)
- Comparative Analysis
- BAX 888: Baxalta / Shire
- BAY2599023: Bayer / Ultragenix pharmaceutical
- Early Stage Products (Phase I)
- Gene therapy: Expression Therapeutics, LLC
- Hemophilia A Key Companies
- Hemophilia A Key Products
- Hemophilia A- Unmet Needs
- Hemophilia A- Market Drivers and Barriers
- Hemophilia A- Future Perspectives and Conclusion
- Hemophilia A Analyst Views
- Hemophilia A Key Companies
- Appendix
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