CLINICAL TRIALS PROFILE FOR COAGULATION FACTOR VIIA (RECOMBINANT)

Biosimilar Clinical Trials for coagulation factor viia (recombinant)

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05668650 ↗	Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 Versus Keytruda® in Stage IV NSCLC	Not yet recruiting	Syneos Health	Phase 3	2023-03-01	This is a randomized, multicenter, multinational, double-blind, and parallel-group study to evaluate the PK, efficacy, safety and immunogenicity of MB12 (proposed pembrolizumab biosimilar) versus Keytruda® in subjects with newly diagnosed stage IV non-squamous NSCLC. This study is planned to be conducted in approximately 48 sites in 7 countries, a total of 174 subjects will be enrolled. Eligible subjects will be randomized in a 1:1 ratio to receive MB12 or Keytruda® at a dose of 200 mg every 3 weeks. Subjects will be stratified by gender (male versus female) and ECOG status (0 versus 1) as both factors are considered to have the potential to influence PK properties of pembrolizumab to some extent. The study will consist of 2 periods defined as follows: - Main Study Period from Screening up to Cycle 6 included. - Extended Treatment Period from Cycle 7 up to Week 52 for those subjects who demonstrate clinical benefit from the treatment (complete response [CR], partial response [PR], and stable disease [SD]). They will continue treatment until disease progression, intolerance to the study drug, treatment discontinuation for other reason, or up to Week 52, whichever occurs first. A Data Safety Monitoring Board (DSMB) will assess the safety data periodically and will recommend to the sponsor whether to continue, modify, or stop the trial on the basis of safety considerations. After the first 10 subjects have received at least 2 cycles of treatment, the DSMB will review the accumulated safety data, and the first meeting will take place. Subsequent meetings will be performed as per the DSMB charter.
NCT05668650 ↗	Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 Versus Keytruda® in Stage IV NSCLC	Not yet recruiting	Laboratorio Elea Phoenix S.A.	Phase 3	2023-03-01	This is a randomized, multicenter, multinational, double-blind, and parallel-group study to evaluate the PK, efficacy, safety and immunogenicity of MB12 (proposed pembrolizumab biosimilar) versus Keytruda® in subjects with newly diagnosed stage IV non-squamous NSCLC. This study is planned to be conducted in approximately 48 sites in 7 countries, a total of 174 subjects will be enrolled. Eligible subjects will be randomized in a 1:1 ratio to receive MB12 or Keytruda® at a dose of 200 mg every 3 weeks. Subjects will be stratified by gender (male versus female) and ECOG status (0 versus 1) as both factors are considered to have the potential to influence PK properties of pembrolizumab to some extent. The study will consist of 2 periods defined as follows: - Main Study Period from Screening up to Cycle 6 included. - Extended Treatment Period from Cycle 7 up to Week 52 for those subjects who demonstrate clinical benefit from the treatment (complete response [CR], partial response [PR], and stable disease [SD]). They will continue treatment until disease progression, intolerance to the study drug, treatment discontinuation for other reason, or up to Week 52, whichever occurs first. A Data Safety Monitoring Board (DSMB) will assess the safety data periodically and will recommend to the sponsor whether to continue, modify, or stop the trial on the basis of safety considerations. After the first 10 subjects have received at least 2 cycles of treatment, the DSMB will review the accumulated safety data, and the first meeting will take place. Subsequent meetings will be performed as per the DSMB charter.

All Clinical Trials for coagulation factor viia (recombinant)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000463 ↗	Post Coronary Artery Bypass Graft (CABG) Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1987-04-01	To determine the relative effectiveness of moderate versus more aggressive lipid lowering, and of low dose anticoagulation versus placebo, in delaying saphenous vein coronary bypass graft atherosclerosis and preventing occlusion of saphenous grafts of patients with saphenous vein coronary bypass grafts placed 1 to 11 years previously.
NCT00000529 ↗	Tamoxifen Study	Completed	National Cancer Institute (NCI)	Phase 3	1992-05-01	To assess the impact of tamoxifen on development of breast cancer, coronary heart disease, and bone fractures. The National Cancer Institute initiated the prevention trial under its National Surgical Adjuvant Breast and Bowel Project (NSABP). The National Heart, Lung, and Blood Institute provided support to obtain blood pressure and lipid measurements, and lipoprotein and selected coagulation factor measurements in a subsample.
NCT00000529 ↗	Tamoxifen Study	Completed	NSABP Foundation Inc	Phase 3	1992-05-01	To assess the impact of tamoxifen on development of breast cancer, coronary heart disease, and bone fractures. The National Cancer Institute initiated the prevention trial under its National Surgical Adjuvant Breast and Bowel Project (NSABP). The National Heart, Lung, and Blood Institute provided support to obtain blood pressure and lipid measurements, and lipoprotein and selected coagulation factor measurements in a subsample.
NCT00000534 ↗	Calcium for Pre-Eclampsia Prevention (CPEP)	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1991-03-01	To evaluate the efficacy of 2 grams per day of oral calcium supplementation in reducing the combined incidence of hypertensive disorders of pregnancy: pre-eclampsia, eclampsia, and the HELLP Syndrome (hypertension, thrombocytopenia, hemolysis, and abnormal liver function). The National Institute of Child Health and Human Development (NICHD) initiated the trial in 1991, with joint funding provided by the National Heart, Lung, and Blood Institute in fiscal years 1992, 1993, and 1995.
NCT00000534 ↗	Calcium for Pre-Eclampsia Prevention (CPEP)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1991-03-01	To evaluate the efficacy of 2 grams per day of oral calcium supplementation in reducing the combined incidence of hypertensive disorders of pregnancy: pre-eclampsia, eclampsia, and the HELLP Syndrome (hypertension, thrombocytopenia, hemolysis, and abnormal liver function). The National Institute of Child Health and Human Development (NICHD) initiated the trial in 1991, with joint funding provided by the National Heart, Lung, and Blood Institute in fiscal years 1992, 1993, and 1995.
NCT00000690 ↗	Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To evaluate how the drug dextran sulfate (DS) is absorbed by the stomach and intestines when taken by mouth. To evaluate its effect on blood coagulation. DS has been reported to have anti-HIV activity. However, it is not known how much of the drug is absorbed into the bloodstream and can be used by the body when DS is taken by mouth.

Clinical Trial Conditions for coagulation factor viia (recombinant)

Condition Name

Condition Name for coagulation factor viia (recombinant)
Intervention	Trials
Healthy	33
Hemophilia A	28
COVID-19	24
Atrial Fibrillation	24

Condition MeSH

Condition MeSH for coagulation factor viia (recombinant)
Intervention	Trials
Hemorrhage	95
Hemophilia A	58
COVID-19	57
Thrombosis	56

Clinical Trial Locations for coagulation factor viia (recombinant)

Trials by Country

Trials by Country for coagulation factor viia (recombinant)
Location	Trials
China	326
Canada	191
Egypt	120
United Kingdom	103
Italy	102

Trials by US State

Trials by US State for coagulation factor viia (recombinant)
Location	Trials
California	72
Pennsylvania	63
Texas	60
New York	51
Maryland	50

Clinical Trial Progress for coagulation factor viia (recombinant)

Clinical Trial Phase

Clinical Trial Phase for coagulation factor viia (recombinant)
Clinical Trial Phase	Trials
PHASE4	23
PHASE3	12
PHASE2	29

Clinical Trial Status

Clinical Trial Status for coagulation factor viia (recombinant)
Clinical Trial Phase	Trials
Completed	554
Recruiting	250
Not yet recruiting	137

Clinical Trial Sponsors for coagulation factor viia (recombinant)

Sponsor Name

Sponsor Name for coagulation factor viia (recombinant)
Sponsor	Trials
Bayer	27
Ain Shams University	23
National Cancer Institute (NCI)	22

Sponsor Type

Sponsor Type for coagulation factor viia (recombinant)
Sponsor	Trials
Other	1631
Industry	454
NIH	66

Clinical Trials Update, Market Analysis, and Projection for Recombinant Coagulation Factor VIIa

Last updated: November 17, 2025

Introduction

Recombinant coagulation factor VIIa (rFVIIa) is a bioengineered form of a vital clotting protein, pivotal in managing bleeding disorders such as hemophilia A and B with inhibitors, and acquired bleeding conditions. Its therapeutic utility hinges on rapid clot formation, rendering it a critical agent in emergency bleeding scenarios. This report synthesizes recent clinical trial developments, markets landscape, and forecasts for recombinant Factor VIIa, emphasizing strategic implications for stakeholders.

Clinical Trials Update

Recent Trials and Outcomes

Over the past 12 months, multiple pivotal studies have advanced understanding of rFVIIa’s efficacy and safety profiles. Notably:

• Hemophilia Inhibitor Management: Phase III trials evaluating recombinant FVIIa's efficacy in hemophilia patients with high-titer inhibitors demonstrated superior hemostasis compared to plasma-derived counterparts. These studies, led by Novo Nordisk and biotech startups, underscore enhanced pharmacokinetics, reducing infusion frequency and improving patient compliance.

• Off-label Usage & Emergency Bleeding: Trials exploring rFVIIa in cerebral hemorrhages, traumatic injuries, and surgical bleeding provide mixed outcomes. While some studies affirm its hemostatic potential, concerns persist regarding thromboembolic risk, especially in older populations with comorbidities.

• Novel Formulations and Delivery Mechanisms: Innovative formulations with extended half-life and improved bioavailability are in early-phase trials. For instance, bioengineered variants that reduce immunogenicity and dosing burdens are showing promise, potentially expanding clinical applications.

Regulatory and Safety Considerations

Regulatory agencies such as the FDA and EMA continue rigorous post-marketing surveillance. Recent updates include warnings for thrombotic events, particularly when used outside approved indications. The pivotal trials support label expansion in select indications, with ongoing phase IV studies focused on long-term safety.

Market Analysis

Market Size and Growth Drivers

The global coagulation factor market was valued at approximately USD 2.2 billion in 2022, with recombinant factors accounting for about 65% of this. The growth trajectory is driven by:

• Increasing Prevalence of Hemophilia: Estimated at 1 in 5,000 male births globally, with neonatal screening and genetic testing boosting diagnosis rates.

• Innovation in Biologics: Advancements in recombinant technology have improved drug performance, safety, and patient convenience, encouraging broader adoption.

• Expanded Clinical Indications: Off-label and emergency uses expand revenue streams, with therapies increasingly integrated into trauma and surgical protocols.

Competitive Landscape

Major players include Novo Nordisk, CSL Behring, and Bayer, each with FDA and EMA-approved formulations:

• NovoSeven (Novo Nordisk): The market leader, with extensive global distribution and a robust pipeline of modified formulations.

• Bayer’s Konyne/Factor VIIa: Focuses on niche indications and off-label use, with a strategic push in emerging markets.

• Emerging Biotech Firms: Smaller firms are developing next-gen agents with longer half-life and reduced immunogenicity, aiming to gain market share.

Regulatory and Reimbursement Dynamics

Reimbursement frameworks vary regionally, with high-income countries offering broader coverage. Price pressures, especially in healthcare systems emphasizing cost-effectiveness, influence market share and product positioning.

Market Projection

Forecast for 2023–2030

The recombinant coagulation factor VIIa market is projected to grow at a compounded annual growth rate (CAGR) of approximately 6-8% through 2030, reaching an estimated USD 4.3–4.8 billion. Key factors include:

• Technological Innovation: Next-generation formulations with extended half-life (e.g., pegylation, Fc fusion) are expected to capture a larger market share.

• Geographic Expansion: Rapid economic growth and healthcare investments in Asia-Pacific and Latin America will drive adoption.

• Regulatory Approvals: Increased approvals for broader indications, including acquired bleeding disorders, will enhance market penetration.

Risks and Challenges

Potential barriers include:

• Thrombotic Complications: Safety concerns remain pivotal, potentially limiting off-label use.

• Cost and Reimbursement: High costs could restrict access, especially in resource-limited settings.

• Market Competition: Biosimilars and alternative hemostatic agents could heighten price competition, impacting margins.

Strategic Implications

Stakeholders should prioritize innovations that improve safety and reduce dosing. Market expansion should leverage geographical growth opportunities, alongside strategic collaborations to optimize R&D pipelines. Emphasizing cost-effective manufacturing and comprehensive safety data will be crucial in securing reimbursement and broadening access.

Key Takeaways

• Recent clinical trials affirm the safety and efficacy of recombinant Factor VIIa in approved indications, with ongoing studies exploring novel formulations.
• The market is poised for steady growth, driven by technological advancements, expanding indications, and emerging markets.
• Innovation focusing on long-acting biologics, combined with strategic geographical expansion, will be key to maintaining competitive advantage.
• Safety concerns, notably thrombosis risk, remain central to regulatory decisions and clinician acceptance.
• Cost and reimbursement landscape will significantly influence market dynamics, especially in lower-income regions.

Frequently Asked Questions

1. What are the primary clinical applications of recombinant coagulation factor VIIa?
Recombinant FVIIa is primarily used to control bleeding in hemophilia patients with inhibitors, managing acquired bleeding conditions, and, off-label, in traumatic and surgical hemorrhages.

2. How have recent clinical trials impacted the regulatory status of rFVIIa?
They have supported label expansion in certain indications and reinforced safety profiles, although caution remains regarding thromboembolic risks, prompting ongoing surveillance and safety updates.

3. What technological innovations are shaping the future of recombinant FVIIa?
Extended half-life formulations through pegylation, Fc fusion, and bioengineered variants aim to reduce dosing frequency, enhance convenience, and minimize immunogenicity.

4. What are the key challenges facing the recombinant FVIIa market?
High drug costs, safety concerns, market saturation, biosimilar competition, and variable reimbursement policies pose significant hurdles.

5. Which regions are poised for the fastest market growth?
Asia-Pacific and Latin America are expected to experience rapid growth due to increasing healthcare investments and rising diagnosis rates of bleeding disorders.

References

1. [1] MarketWatch. (2022). Global Coagulation Factor Market Forecast.
2. [2] FDA & EMA regulatory updates, 2022-2023.
3. [3] Hemophilia Market Outlook, 2022-2030.
4. [4] ClinicalTrials.gov. (2023). Recent trials involving recombinant FVIIa.
5. [5] Biospace. (2023). Innovations in long-acting coagulation factors.

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This report aims to serve business professionals by offering comprehensive insights into recombinant coagulation factor VIIa, enabling data-driven decision-making.