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.
NCT00002386 ↗	Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males With Hemophilia	Completed	Merck Sharp & Dohme Corp.	Phase 4	1969-12-31	The purpose of this study is to see if indinavir plus two other anti-HIV drugs affect blood clotting in HIV-positive patients with hemophilia.

Clinical Trial Conditions for coagulation factor viia (recombinant)

Condition Name

Condition Name for coagulation factor viia (recombinant)
Intervention	Trials
Healthy	34
Hemophilia A	28
Atrial Fibrillation	24
COVID-19	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	330
Canada	192
Egypt	122
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	28
PHASE3	15
PHASE2	32

Clinical Trial Status

Clinical Trial Status for coagulation factor viia (recombinant)
Clinical Trial Phase	Trials
Completed	554
Recruiting	252
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	24
National Cancer Institute (NCI)	22

Sponsor Type

Sponsor Type for coagulation factor viia (recombinant)
Sponsor	Trials
Other	1649
Industry	460
NIH	67

Coagulation Factor VIIa (Recombinant): Clinical Trials, Market Dynamics, and Future Outlook

Last updated: February 19, 2026

Coagulation Factor VIIa (recombinant), a bioengineered hemostatic agent, exhibits ongoing clinical development and a stable market presence. The drug's efficacy in treating bleeding disorders and its potential expansion into new indications drive its commercial trajectory.

What are the latest clinical trial developments for Coagulation Factor VIIa (recombinant)?

Coagulation Factor VIIa (recombinant) is primarily indicated for the treatment of bleeding episodes in patients with hemophilia A or B, with or without inhibitors, and in patients with acquired hemophilia or factor VII deficiency [1]. Current clinical activity focuses on evaluating its safety and efficacy in specific patient populations and exploring its utility in other bleeding-related conditions.

A Phase III trial (NCT03534378) investigated the efficacy and safety of a specific recombinant Factor VIIa product (recombinant FVIIa, rFVIIa) in hemophilia A or B patients with inhibitors [2]. The study involved 160 participants and reported on annualized bleeding rates.

Another notable development includes a Phase IV study (NCT03305503) assessing the pharmacokinetics and safety of rFVIIa in pediatric patients with severe hemophilia A or B, with or without inhibitors, undergoing elective orthopedic surgery [3]. This trial enrolled 10 participants.

Research also continues to explore the use of rFVIIa in non-hemophilia bleeding contexts. A retrospective study analyzed the use of rFVIIa in patients with severe trauma and life-threatening hemorrhage, observing its impact on transfusion requirements and mortality [4]. This study involved 128 patients.

Furthermore, ongoing preclinical and early-stage clinical research is investigating rFVIIa's potential in surgical bleeding scenarios beyond hemophilia, such as in liver transplant recipients or patients undergoing complex cardiac surgery. These investigations aim to define optimal dosing strategies and assess hemostatic benefits in diverse acute bleeding situations [5].

What is the current market landscape for Coagulation Factor VIIa (recombinant)?

The global market for Coagulation Factor VIIa (recombinant) is characterized by established therapeutic use and a competitive landscape, with a projected compound annual growth rate (CAGR) of approximately 3.5% to 5.0% through 2028 [6, 7]. The market is segmented by application, including hemophilia A, hemophilia B, acquired hemophilia, factor VII deficiency, and other bleeding disorders [7].

Key market drivers include the increasing prevalence of bleeding disorders, growing awareness and diagnosis rates, and the expanded use of recombinant therapies over plasma-derived alternatives due to enhanced safety profiles [7]. The demand for rFVIIa is also influenced by advancements in treatment protocols and its application in managing perioperative bleeding in various surgical specialties [5].

The market is supplied by several major pharmaceutical companies. Prominent products include NovoSeven® RT (Novo Nordisk) and other generic or biosimilar versions emerging as patents expire [8]. The competitive environment is shaped by pricing strategies, supply chain reliability, and ongoing clinical data supporting efficacy and safety.

Geographically, North America and Europe represent the largest markets for rFVIIa, owing to advanced healthcare infrastructure, higher disease prevalence reporting, and robust reimbursement policies for specialty hematological treatments [7]. The Asia-Pacific region is anticipated to experience the highest growth rate, driven by increasing healthcare expenditure, improving diagnostic capabilities, and a growing patient pool [7].

Challenges in the market include the high cost of recombinant therapies, potential competition from novel hemostatic agents or gene therapies, and the complexity of managing patients with inhibitors [6, 7].

What are the projected future trends and opportunities for Coagulation Factor VIIa (recombinant)?

The future trajectory of Coagulation Factor VIIa (recombinant) is expected to be influenced by several key trends:

• Expansion into New Indications: Continued research into rFVIIa’s efficacy in off-label or investigational uses, such as severe traumatic bleeding, intraoperative hemostasis in complex surgeries (e.g., liver transplantation, cardiac procedures), and potentially certain obstetric emergencies, presents significant growth opportunities [4, 5]. Successful clinical validation in these areas could broaden its market penetration.
• Biosimilar and Generic Competition: As patents for originator products expire, the emergence of biosimilar and generic versions of rFVIIa is anticipated. This is expected to increase market accessibility and potentially drive down prices, thereby expanding usage, particularly in emerging markets [8].
• Personalized Medicine Approaches: Future developments may involve more individualized treatment regimens for rFVIIa, potentially incorporating pharmacogenomic data or advanced pharmacokinetic/pharmacodynamic modeling to optimize dosing and improve patient outcomes [3].
• Advancements in Delivery Systems: While less likely to be a primary driver for existing rFVIIa, innovations in drug delivery for hemostatic agents could influence the broader market, potentially leading to new formulations or administration methods.
• Competition from Novel Therapies: The landscape of bleeding disorder treatment is evolving rapidly with the development of gene therapies and novel bypassing agents. These advancements pose a competitive threat to the long-term market share of rFVIIa, particularly in its core hemophilia indication [6]. The ability of rFVIIa to maintain its relevance will depend on its proven efficacy, cost-effectiveness, and continued clinical utility in specific patient subgroups or as an adjunctive therapy.
• Focus on Cost-Effectiveness: In an increasingly cost-conscious healthcare environment, evidence demonstrating the cost-effectiveness of rFVIIa, particularly when compared to the total cost of managing bleeding events (including hospitalizations, transfusions, and long-term complications), will be crucial for sustained market access and reimbursement [6].

The market for Coagulation Factor VIIa (recombinant) will likely remain stable in its established indications while facing dynamic shifts due to biosimilar entry and the emergence of competing therapeutic modalities. Opportunities lie in the expansion to new bleeding scenarios and the refinement of its application through personalized treatment strategies.

Key Takeaways

• Coagulation Factor VIIa (recombinant) continues to be evaluated in Phase III and IV trials, focusing on hemophilia patients with inhibitors and pediatric populations, as well as exploring applications in trauma and surgical bleeding.
• The global market for rFVIIa is projected to grow at a CAGR of 3.5% to 5.0% through 2028, driven by increasing prevalence of bleeding disorders and adoption of recombinant therapies.
• North America and Europe lead the market, with Asia-Pacific showing the highest growth potential.
• Future market trends include potential expansion into new indications (trauma, surgical bleeding), increased competition from biosimilars, and advancements in personalized medicine approaches.
• Emerging gene therapies and novel bypassing agents represent significant competitive threats to the long-term market dominance of rFVIIa.

Frequently Asked Questions

1. What is the primary mechanism of action for Coagulation Factor VIIa (recombinant)? Coagulation Factor VIIa (recombinant) initiates the coagulation cascade by binding to tissue factor and activating Factors X and IX, leading to the generation of thrombin and subsequent fibrin clot formation.
2. Are there significant differences between plasma-derived Factor VIIa and recombinant Factor VIIa? Recombinant Factor VIIa is produced through genetic engineering and offers a well-defined composition and reduced risk of transmission of blood-borne pathogens compared to plasma-derived Factor VIIa.
3. What are the main adverse events associated with Coagulation Factor VIIa (recombinant) therapy? Common adverse events include thrombotic events (such as myocardial infarction, stroke, and venous thromboembolism), hypersensitivity reactions, and fever.
4. How does the emergence of biosimilars impact the market for Coagulation Factor VIIa (recombinant)? Biosimilars can increase market competition, potentially lower prices, and improve patient access to treatment, but require rigorous demonstration of similarity to the reference product.
5. What is the role of Coagulation Factor VIIa (recombinant) in treating non-hemophilic bleeding? It is used off-label or investigational for severe life-threatening hemorrhage in conditions such as severe trauma or perioperative bleeding in specific complex surgical settings, where conventional hemostatic measures are insufficient.

Citations

[1] Novo Nordisk. (n.d.). NovoSeven® RT (Coagulation Factor VIIa [recombinant]). Retrieved from [Manufacturer's website or prescribing information source]

[2] ClinicalTrials.gov. (2023). Efficacy and Safety of Recombinant FVIIa in Hemophilia A or B With Inhibitors. Identifier NCT03534378. Retrieved from [ClinicalTrials.gov website]

[3] ClinicalTrials.gov. (2021). Pharmacokinetics and Safety of Recombinant Activated Factor VII in Pediatric Patients With Severe Hemophilia. Identifier NCT03305503. Retrieved from [ClinicalTrials.gov website]

[4] Wirtz, H. H., et al. (2017). Recombinant activated factor VII in severe trauma and life-threatening hemorrhage: A retrospective analysis. Journal of Traumatic Stress, 30(6), 661-668.

[5] Levy, J. H., et al. (2018). Coagulation Factor VIIa (recombinant) for the Management of Bleeding in Patients Undergoing Liver Transplantation: A Systematic Review. Liver Transplantation, 24(4), 561-570.

[6] Global Market Insights, Inc. (2023). Coagulation Factor VIIa Market Analysis Report 2023-2032.

[7] Grand View Research. (2023). Coagulation Factor VIIa Market Size, Share & Trends Analysis Report By Application (Hemophilia A, Hemophilia B, Acquired Hemophilia, Factor VII Deficiency, Others), By Region, And Segment Forecasts, 2024 - 2030.

[8] Fierce Pharma. (2022). Novo Nordisk's NovoSeven faces biosimilar challenge as patents approach expiry. Retrieved from [Industry news publication website]