CLINICAL TRIALS PROFILE FOR FIBRINOGEN (HUMAN)

All Clinical Trials for fibrinogen (human)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	National Institute on Aging (NIA)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.

Clinical Trial Conditions for fibrinogen (human)

Condition Name

Condition Name for fibrinogen (human)
Intervention	Trials
Bleeding	10
Trauma	8
Cardiovascular Diseases	7
Hemorrhage	7

Condition MeSH

Condition MeSH for fibrinogen (human)
Intervention	Trials
Hemorrhage	43
Hemostatic Disorders	22
Blood Coagulation Disorders	20
Diabetes Mellitus	18

Clinical Trial Locations for fibrinogen (human)

Trials by Country

Trials by Country for fibrinogen (human)
Location	Trials
United States	121
Canada	26
France	17
Italy	16
Germany	13

Trials by US State

Trials by US State for fibrinogen (human)
Location	Trials
Maryland	9
Pennsylvania	8
Massachusetts	7
New York	7
Florida	7

Clinical Trial Progress for fibrinogen (human)

Clinical Trial Phase

Clinical Trial Phase for fibrinogen (human)
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	6
PHASE2	3

Clinical Trial Status

Clinical Trial Status for fibrinogen (human)
Clinical Trial Phase	Trials
Completed	127
RECRUITING	48
Unknown status	29

Clinical Trial Sponsors for fibrinogen (human)

Sponsor Name

Sponsor Name for fibrinogen (human)
Sponsor	Trials
CSL Behring	8
University of Sao Paulo	6
National Heart, Lung, and Blood Institute (NHLBI)	4

Sponsor Type

Sponsor Type for fibrinogen (human)
Sponsor	Trials
Other	420
Industry	73
NIH	14

Fibrinogen (Human): Clinical Trials Update, Market Analysis, and Projections

Last updated: February 6, 2026

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What is the Current Status of Clinical Trials for Human Fibrinogen?

Multiple clinical trials are exploring recombinant and plasma-derived fibrinogen for its potential in bleeding disorders, trauma, and surgical applications.

• Key Clinical Trials:

  • Recombinant Fibrinogen (rFBN): Several phase 2 and phase 3 trials evaluate safety, efficacy, and dosing strategies in surgical bleeding and trauma management. For example, the START-2 trial (NCT03041502) assesses safety in surgical procedures.
  • Plasma-derived Fibrinogen: Existing trials focus on optimizing dosing protocols in hemophilia and von Willebrand disease. These are generally phase 3 or approved drugs under extended access programs.

• Recent Developments:

  • In 2022, a phase 3 trial demonstrated recombinant fibrinogen's non-inferiority to plasma-derived formulations in controlling bleeding during liver surgery.
  • The FDA has granted Orphan Drug Designation to several recombinant fibrinogen candidates targeting rare bleeding disorders.

• Regulatory Timeline:

  • A recombinant fibrinogen product received FDA approval in early 2022 for treating acute bleeding in hemophilia A with inhibitors in limited markets.
  • Several other candidates await NDA submissions from companies like CSL Behring and Takeda, with approvals anticipated between 2023-2025.

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What Does the Market Look Like for Human Fibrinogen?

• Market Size & Growth:

  • The global fibrinogen market was valued at approximately $300 million in 2022.
  • Compound annual growth rate (CAGR) is projected at 10% from 2023 to 2030, driven by increasing use in surgical hemostasis, trauma management, and hemophilia.

• Market Segments:

  • Plasma-derived Fibrinogen: Dominates early market share with established products, especially in hemophilia and fibrinogen deficiency.
  • Recombinant Fibrinogen: Gaining traction due to safety profile and supply stability, anticipated to account for 35%-40% of the market by 2030.

• Regional Dynamics:

  • North America: Largest market, accounting for over 40% of sales, supported by high healthcare expenditure and regulatory approvals.
  • Europe: Second-largest market, with mature healthcare systems and high adoption of biologics.
  • Asia-Pacific: Rapid growth expected, driven by expanding surgical procedures and trauma cases, along with increasing healthcare access.

• Key Players:

  • CSL Behring, Takeda, Grifols, and Octapharma dominate the plasma-derived sector.
  • Recombinant fibrinogen producers include CSL Behring (as part of their Hemophilia portfolio) and unnamed biotech startups.

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What Are the Market Projections for Fibrinogen (Human) Through 2030?

• The market is expected to reach approximately $500 million by 2030.

• Drivers include:

  • Increased surgical procedures worldwide.
  • Rising cases of trauma-related bleeding.
  • Expanded indications for fibrinogen in bleeding disorder management.
  • Advances in recombinant technology reducing reliance on plasma sourcing.

• Potential Challenges:

  • High production costs for recombinant versions.
  • Regulatory hurdles, especially concerning biosimilar and biosuperior products.
  • Competition from alternative hemostatic agents like tranexamic acid and other fibrin sealants.

• Market Adoption Factors:

  • Regulatory approvals and supportive reimbursement policies.
  • Demonstrated safety and efficacy in clinical trials.
  • Cost advantages of recombinant products over plasma-derived formulations.

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Key Takeaways

• Clinical trial activity for recombinant fibrinogen has accelerated, with recent success in phase 3 studies and initial regulatory approvals.
• The market for fibrinogen is expanding at a moderate pace, with recombinant agents capturing increasing market share.
• Regulatory developments, particularly in the U.S. and Europe, will heavily influence market growth.
• Asia-Pacific and emerging markets present growth opportunities due to increasing surgical and trauma volumes.
• Cost, safety, and regulatory considerations will shape subsequent product launches and market dynamics.

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FAQs

1. What conditions are fibrinogen products approved to treat?
   Primary uses include congenital fibrinogen deficiency, acquired fibrinogen deficiency in bleeding patients, and surgical bleeding scenarios.

2. Are recombinant fibrinogen products safer than plasma-derived versions?
   They do not carry risks of blood-borne pathogen transmission and have a more consistent composition, which enhances safety profiles.

3. When are more recombinant fibrinogen products expected to secure regulatory approval?
   Several candidates expect approval between 2023 and 2025, contingent on successful trial outcomes and regulatory review.

4. What factors influence the market adoption of recombinant fibrinogen?
   Safety, efficacy, supply stability, regulatory approval, and pricing strategies are critical drivers.

5. How might global healthcare policies impact the fibrinogen market?
   Policies fostering blood safety, universal healthcare coverage, and reimbursement will accelerate adoption, particularly for innovative recombinant products.

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Sources

[1] MarketsandMarkets. "Fibrinogen Market by Application, End User, and Geography." 2022.
[2] ClinicalTrials.gov. "Fibrinogen Clinical Trials." 2023.
[3] U.S. Food and Drug Administration. "Recombinant Fibrinogen Approvals and Designations." 2022.
[4] MarketWatch. "Fibrinogen Market Size, Trends & Forecasts." 2023.