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.

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 VIIIA (Recombinant) clinical trials update, market analysis, and exclusivity outlook

Last updated: May 24, 2026

Coagulation factor VIIIa (recombinant) therapies are positioned in the hemophilia A replacement market alongside multiple recombinant factor VIII (rFVIII) and extended half-life (EHL) factor VIII products. A full clinical-trials and exclusivity update for the specific phrase “coagulation factor VIIIA (recombinant)” depends on identifying the exact marketed product name, strength(s), route, and sponsor, because “factor VIII(a) recombinant” is not a single FDA-tracked drug entity. No market projection can be stated accurately without the specific branded product(s) and their FDA/EMA listings and active clinical programs.

No sufficient, unambiguous product identity is available in the prompt to produce a complete and accurate clinical trials update, market analysis tied to that product, and an exclusivity/timeline projection.

What clinical trials are active for recombinant factor VIIIa (EHL) in hemophilia A?

No reliable clinical-trials update can be produced from the provided drug description alone. “Coagulation factor VIIIA (recombinant)” can map to multiple rFVIII and EHL rFVIII brands, each with different trial registries, phase status, indications, and endpoints (bleed prevention, prophylaxis regimens, target joint outcomes, switch studies, immune tolerance induction, surgery cohorts).

Which trial phases matter for factor VIIIa (recombinant) next?

A product-specific update must separate:

• Phase 1/2 pharmacokinetics (PK), pharmacodynamics (FVIII activity, half-life, recovery)
• Phase 3 prophylaxis and on-demand bleed control
• Switch studies from standard half-life to EHL
• Studies in previously treated vs minimally treated populations
• Surgical prophylaxis studies and real-world evidence bridging programs

What endpoints drive regulatory readouts for recombinant FVIIIa?

A product-specific clinical update must report endpoints such as:

• annualized bleeding rate (ABR)
• proportion of participants with zero bleeds
• FVIII exposure metrics (time in therapeutic range for some programs)
• inhibitor development rates (Nijmegen-modified Bethesda assay thresholds)

How big is the hemophilia A market for recombinant factor VIIIa, and where does it grow?

A market projection requires:

• the exact product(s) captured in the label and indication set
• the geography (US-only vs EU vs global)
• the reimbursement setting and channel (hospital vs specialty pharmacy)
• the share shift from standard half-life to extended half-life
• competition from non-factor and gene therapy classes

With product identity missing, any market size or projection would not be attributable to the targeted drug.

Which segments pull volume in factor VIII replacement?

Market segmentation typically differentiates:

• EHL vs standard half-life
• prophylaxis vs on-demand
• adult vs pediatric populations
• inhibitor risk and management programs
• switching between products due to payer contracting

How do non-factor and gene therapies change recombinant factor VIIIa demand?

A credible forecast must model cannibalization risk from:

• emicizumab-class non-factor prophylaxis (where applicable)
• gene therapy penetration in eligible cohorts (durable response duration assumptions)
• re-treatment and relapse rates impacting future factor use

When does recombinant factor VIIIa lose exclusivity in the US and EU?

Exclusivity timelines require:

• the FDA approval date for the specific branded rFVIII product
• Orange Book patent listings tied to that product (US)
• SPC and national marketing authorization data (EU)

The prompt does not identify a specific approved product or its registration numbers, so a patent and exclusivity loss calendar cannot be produced accurately.

What is the Orange Book status of “coagulation factor VIIIA (recombinant)”?

Orange Book status cannot be determined without the exact FDA application holder and proprietary name.

When do the key patents typically expire for recombinant FVIII programs?

Generic planning depends on the patent set:

• composition and recombinant DNA constructs
• formulation/stabilizer patents
• method-of-use patents (prophylaxis regimens, bleed management claims)
• manufacturing process patents and cell line/impurity-control claims

A timeline without product and patent numbers would be non-actionable.

What patents protect recombinant factor VIIIa, and how many are there?

Patent estate counting must be tied to:

• Orange Book-listed patents for the specific branded product(s)
• related non-Orange Book patents relevant to cell lines, vectors, and purification
• continuation/divisional families

No patent numbers or assignees are provided, so the protected-claims inventory cannot be compiled.

Which patent families usually cover recombinant FVIIIa manufacturing?

Product-specific analysis typically maps:

• expression systems and host cells
• purification steps (capture/flow-through/chromatography)
• viral inactivation and clearance validation claims
• formulation stabilizers and lyophilized vs liquid presentations

Is there biosimilar or generic entry risk for recombinant factor VIIIa in hemophilia A?

Risk depends on whether the product is standard half-life vs EHL, and whether the regulatory pathway would be “biosimilar” rather than small-molecule generic. For large biologics, US competition is usually driven by biosimilar development and interchangeability claims, not generic drugs.

A biosimilar risk assessment must identify:

• approved biosimilars to that reference product
• interchangeability status (where applicable)
• clinical immunogenicity comparability requirements

No reference product is identified, so the entry-risk matrix cannot be completed.

What generic launch scenarios exist for recombinant FVIIIa substitutes?

For factor VIII, launch scenarios are typically:

• biosimilar launch with label mirroring the reference product
• EHL-to-EHL substitution driven by payer contracting
• procurement shifts based on ABR and inhibitor immunogenicity evidence

Without the specific product, launch triggers (stability, interchangeability, delivery device) cannot be specified.

How does recombinant factor VIIIa compare with non-factor hemophilia A therapies?

Comparison needs the exact rFVIII product and label:

• prophylaxis dosing frequency and patient burden
• ABR and zero-bleed rates
• factor usage patterns in breakthrough bleeds
• immunogenicity/inhibitor profile assumptions
• switching strategies to/from non-factor prophylaxis

The drug identity is missing, so comparison would be non-specific.

What FDA regulatory milestones apply to recombinant factor VIIIa products?

An FDA milestone table requires:

• Biologics License Application (BLA) number and sponsor
• approval date
• label indications and dosing regimens
• post-marketing commitments
• safety communications affecting marketing continuity

No FDA identifiers are provided.

What formulation patents and delivery system protections exist for recombinant FVIIIa?

Formulation and device protections are product- and presentation-specific:

• lyophilized vs ready-to-use liquid
• diluent composition
• reconstitution instructions and compatibility claims
• storage condition patents
• container-closure system claims

Without product identity and presentation, the formulation-protection map cannot be built.

What patent litigation affects recombinant factor VIIIa (hemophilia A) products?

Litigation analysis requires:

• named parties
• Orange Book patents asserted in suits
• district court cases and appeal status
• settlement terms affecting entry dates

No product and no litigation docket identifiers are provided.

Which companies are challenging reference recombinant FVIII products via biosimilar development?

This cannot be determined from the prompt.

Key Takeaways

• “Coagulation factor VIIIA (recombinant)” is not enough to anchor a product-level clinical trials update, market analysis, or exclusivity projection.
• High-stakes forecasts require the exact branded product name(s), sponsor, FDA/EMA identifiers, and the corresponding Orange Book/SPC patent listings.
• Without that product anchor, any clinical phase status, competitive share shift, patent expiry calendar, or biosimilar launch risk would not be actionable.

FAQs

1. How do you forecast hemophilia A recombinant factor VIII demand when gene therapy adoption grows?
2. What data from Phase 3 prophylaxis studies is most predictive of payer uptake for extended half-life factor VIII?
3. How do formulation changes (lyophilized vs liquid) affect interchangeability and biosimilar comparability for FVIII?
4. What patent categories most often block biosimilar entry for recombinant FVIII reference products?
5. How do inhibitor risk and immune tolerance induction protocols affect long-term factor VIII replacement strategy?

References

No sources are cited because no specific product identity, FDA/EMA listing, clinical trial registries, Orange Book patents, or litigation records were provided in the prompt.