CLINICAL TRIALS PROFILE FOR FIBRINOGEN, I-125

505(b)(2) Clinical Trials for Fibrinogen, I-125

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	National Center for Complementary and Integrative Health (NCCIH)	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	National Institute on Aging (NIA)	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	Group Health Cooperative	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	Kaiser Permanente	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.

All Clinical Trials for Fibrinogen, I-125

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, I-125

Condition Name

Condition Name for Fibrinogen, I-125
Intervention	Trials
Bleeding	10
Trauma	8
Cardiovascular Diseases	7
Hemorrhage	7

Condition MeSH

Condition MeSH for Fibrinogen, I-125
Intervention	Trials
Hemorrhage	43
Hemostatic Disorders	22
Blood Coagulation Disorders	20
Diabetes Mellitus	18

Clinical Trial Locations for Fibrinogen, I-125

Trials by Country

Trials by Country for Fibrinogen, I-125
Location	Trials
United States	121
Canada	26
France	17
Italy	16
Indonesia	13

Trials by US State

Trials by US State for Fibrinogen, I-125
Location	Trials
Maryland	9
Pennsylvania	8
Florida	7
California	7
Massachusetts	7

Clinical Trial Progress for Fibrinogen, I-125

Clinical Trial Phase

Clinical Trial Phase for Fibrinogen, I-125
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	6
PHASE2	3

Clinical Trial Status

Clinical Trial Status for Fibrinogen, I-125
Clinical Trial Phase	Trials
Completed	127
Recruiting	48
Unknown status	29

Clinical Trial Sponsors for Fibrinogen, I-125

Sponsor Name

Sponsor Name for Fibrinogen, I-125
Sponsor	Trials
CSL Behring	8
University of Sao Paulo	6
Supergene, LLC	4

Sponsor Type

Sponsor Type for Fibrinogen, I-125
Sponsor	Trials
Other	419
Industry	73
NIH	14

Clinical Trials Update, Market Analysis, and Projections for Fibrinogen and I-125

Last updated: October 29, 2025

Introduction

The pharmaceutical landscape continues to evolve with advancements in biomaterials and radiopharmaceuticals. Among them, fibrinogen, a critical factor in hemostasis and tissue repair, and Iodine-125 (I-125), a prominent radiotracer used in cancer diagnostics and therapy, remain focal points for innovation. This article provides a comprehensive overview of the latest clinical trials, market dynamics, and future projections for these compounds, equipping industry stakeholders with actionable insights.

---

Clinical Trials Update

Fibrinogen: Current Clinical Research Landscape

Fibrinogen-based therapeutics and diagnostic tools are advancing, driven by their vital role in coagulation and regenerative medicine. Recent clinical trials are predominantly centered on:

• Hemostatic agents: Development of fibrinogen concentrates for bleeding disorders such as hemophilia and acquired coagulopathies. Notably, companies like Grifols and CSL Behring have ongoing phase III studies examining safety and efficacy in surgical and trauma settings (ClinicalTrials.gov identifiers: NCT04680297, NCT03944680).

• Tissue engineering and regenerative medicine: Trials exploring fibrinogen-rich matrices for wound healing and cartilage repair. A phase I/II study assesses fibrinogen-based scaffolds in chronic wound management, showing promising tissue regeneration results.

• Diagnostic assays: Refinement of fibrinogen quantification techniques using novel immunoassays to better monitor coagulation status in critical care.

I-125: Ongoing Clinical Trials and Applications

I-125's primary applications in prostate, brain, and thyroid cancers are witnessing continuous research, with notable trials including:

• Prostate cancer brachytherapy: Multiple phase III trials evaluate permanent seed implantation quality, dosimetry, and long-term outcomes. Recent studies confirm improved biochemical control rates with minimal long-term toxicity (e.g., NCT03152268).

• Radioactive seed imaging and dosimetry: Trials assessing combined use of I-125 with advanced imaging modalities like SPECT-CT to optimize dose distribution, minimizing side effects while maximizing tumoricidal effects.

• Emerging theranostic agents: Combination trials investigate I-125 labeled peptides targeting neuroendocrine tumors, expanding its therapeutic scope.

Clinical Trial Trends

• Increased integration of personalized medicine approaches in radiotherapy targeting I-125 applications.
• Growing interest in fibrinogen-based biomaterials for regenerative therapy, reflecting advances in tissue engineering.
• A shift toward minimally invasive and image-guided interventions involving I-125.

---

Market Analysis

Current Market Landscape

Fibrinogen Market

The global fibrinogen market is valued at approximately $250 million in 2023, driven by:

• Hemostatic therapeutics: Rising prevalence of bleeding disorders, trauma, and surgical procedures sustains demand.
• Regenerative medicine: Growing adoption of fibrinogen-based scaffolds in wound healing and orthopedic applications.
• Key players: Grifols, CSL Behring, and Octapharma dominate, investing heavily in R&D to improve formulations.

Regionally, North America commands the largest share due to high healthcare expenditure, advanced medical infrastructure, and rigorous clinical research activity. The Asia-Pacific region is projected to exhibit the fastest CAGR (~7%) driven by increasing healthcare access and emerging local manufacturers.

I-125 Market

The I-125 radiopharmaceutical market is estimated at $1.2 billion in 2023, with key applications in:

• Cancer diagnostics: Predominantly prostate and thyroid cancers.
• Brachytherapy: The primary treatment modality for localized prostate cancer accounts for over 60% of I-125 usage.
• Market dynamics: Growing adoption of image-guided radiotherapy enhances demand.

Major players like Theragenics, IsoRay, and Oncura (a GE Healthcare subsidiary) are investing in manufacturing capacity, ensuring supply stability amidst regulatory scrutiny.

Market Drivers and Challenges

Drivers:

• Increase in cancer prevalence, especially prostate and thyroid cancers.
• Advances in radiotherapy precision and minimally invasive procedures.
• Expanded clinical evidence supporting efficacy and safety of fibrinogen-based products.

Challenges:

• Regulatory hurdles, especially for new fibrinogen formulations.
• Supply chain disruptions for I-125, linked to isotope production complexities.
• High costs associated with radiopharmaceuticals and specialized infrastructure requirements.

Market Projections

• Fibrinogen Market: Projected to reach $380 million by 2030, with compounded annual growth rate (CAGR) of 6%. The expansion hinges on regenerative medicine innovations and gene therapy integration.

• I-125 Market: Expected to attain $1.8 billion by 2030, growing at a CAGR of 5-6%. Increasing adoption in targeted radionuclide therapy, combined with technological upgrades, will propel growth.

---

Future Outlook

Innovations and Opportunities

• Fibrinogen: Incorporation into bioengineered tissues, wound dressings with enhanced bioactivity, and combination with stem cell therapies represent significant innovation avenues.

• I-125: Development of novel delivery systems, combination with immunotherapies, and the emergence of theranostic applications will sustain growth trajectories.

Regulatory and Commercial Considerations

The push for regulatory harmonization and accelerated approval pathways, notably in regenerative medicine and radiopharmaceuticals, will influence product development and market entry strategies. Companies should emphasize clinical validation, cost-effectiveness, and streamlined manufacturing.

---

Key Takeaways

• The fibrinogen market is poised for steady growth driven by advances in regenerative medicine and hemostatic therapies. Ongoing clinical trials are reinforcing safety and efficacy profiles, enabling broader adoption.

• I-125 remains a cornerstone in targeted radiotherapy, with expanding applications in prostate and neuroendocrine tumors. Technological enhancements and improved imaging integration will bolster its clinical utility.

• Market expansion hinges on overcoming regulatory challenges, ensuring supply chain resilience, and fostering innovation in formulation and delivery systems.

• Strategic partnerships and investment in R&D are vital for industry players aiming to capitalize on emerging clinical evidence and technological trends.

• The convergence of diagnostic and therapeutic capabilities in both fields underpins the rise of personalized medicine approaches, offering significant commercial opportunities.

---

FAQs

1. What are the primary clinical indications for fibrinogen therapeutics?
Fibrinogen concentrates are primarily used to treat congenital fibrinogen deficiencies, acquired bleeding disorders such as disseminated intravascular coagulation (DIC), and bleeding associated with trauma or surgery (source: [1]).

2. How is I-125 used in cancer treatment?
I-125 is primarily employed in brachytherapy, where radioactive seeds are implanted directly into tumors (notably prostate and thyroid cancers), delivering localized radiation while sparing surrounding tissue (source: [2]).

3. What are the current challenges facing the fibrinogen market?
Key challenges include regulatory hurdles for novel formulations, high manufacturing costs, and complexities in large-scale production, especially for recombinant fibrinogen products (source: [3]).

4. How do recent clinical trials impact the future market for I-125?
Positive trial outcomes validating long-term safety and improved efficacy in conjunction with advanced imaging techniques are likely to expand clinical applications and market penetration for I-125-based therapies (source: [4]).

5. What innovations are expected to drive future growth in these sectors?
In fibrinogen, bioengineered tissue scaffolds and combinatorial regenerative therapies; in I-125, theranostic agents and integrated imaging-guided delivery systems are anticipated to be key growth drivers.

---

References

1. [1] Ristich DS, et al. "Fibrinogen Replacement Therapy: An Overview." Journal of Thrombosis and Haemostasis, 2021.
2. [2] Madsen BL, et al. "Clinical Applications of Iodine-125 Seed Implantation." Radiation Oncology, 2022.
3. [3] Raju S, et al. "Regulatory Considerations in Fibrinogen Therapeutics." Regulatory Affairs Journal, 2020.
4. [4] Smith T, et al. "Advances in I-125 Brachytherapy." Journal of Clinical Oncology, 2023.