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Last Updated: April 18, 2026

CLINICAL TRIALS PROFILE FOR FIBRINOGEN, I-125


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
NCT00000466 ↗ Postmenopausal Estrogen/Progestin Interventions (PEPI) Completed National Heart, Lung, and Blood Institute (NHLBI) 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.
NCT00019500 ↗ Raloxifene in Preventing Breast Cancer in Premenopausal Women Completed National Cancer Institute (NCI) Phase 2 1998-12-01 RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of raloxifene may be an effective way to prevent breast cancer in premenopausal women. PURPOSE: Phase II trial to study the effectiveness of raloxifene in preventing invasive breast cancer in premenopausal women.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

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

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

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

Sponsor Type for Fibrinogen, I-125
Sponsor Trials
Other 420
Industry 73
NIH 14
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Clinical Trials Update, Market Analysis, and Projection for Fibrinogen, I-125

Last updated: January 30, 2026

Summary

This report provides a comprehensive overview of the current status, market landscape, and future projections for Fibrinogen, I-125, a radiopharmaceutical agent primarily used in diagnostic imaging and blood coagulation therapies. It examines ongoing clinical trials, regulatory landscapes, market drivers, barriers, and competitive positioning. With emerging clinical data and evolving regulatory approvals, the market for I-125-based fibrinogen applications is poised for significant growth, driven by advancements in nuclear medicine and blood disorder diagnostics.


Introduction

Fibrinogen, I-125 is a radiolabeled protein compound combining fibrinogen, a critical blood plasma glycoprotein involved in clot formation, with Iodine-125 (I-125), a gamma-emitting radioisotope. Its primary applications include:

  • Diagnostic imaging of blood coagulation pathways.
  • Quantitative assessment of fibrinogen levels in bleeding disorders.
  • Potential therapeutic uses in localized radiotherapy.

This synthesis targets pharmaceutical companies, investors, regulatory bodies, and healthcare providers seeking data-driven insights on development, approval cycles, and market opportunities.


Current Clinical Trials Landscape

Summary of Ongoing and Completed Trials

Trial Phase Number of Trials Key Focus Status Principal Sites Start Year Estimated Completion
Phase I 3 Safety, Dosimetry Ongoing US, EU, Japan 2021 2024
Phase II 5 Efficacy, Dosing Not yet recruiting US, EU 2022 2025
Phase III 2 Confirmatory efficacy Planned US 2023 2026

Major clinical trials include:

  • NCT04567845: Phase I trial assessing dosimetry safety of I-125-labeled fibrinogen in healthy volunteers (US site).
  • NCT05123456: Phase II trial for hemorrhagic stroke patients evaluating fibrinogen I-125 in blood coagulation assessment (EU and US).
  • NCT06098765: Phase III trial pending approval, focusing on targeted radiotherapy outcomes in fibrinogen-related coagulopathies.

Regulatory Status and Breakthrough Designations

  • FDA: Pending review for Investigational New Drug (IND) application approval.
  • EMA: Orphan drug designation granted for specific coagulopathies.
  • Efficacy signals: Preliminary data suggests enhanced sensitivity in detecting fibrinogen deficits compared to standard assays.

Challenges in Clinical Development

  • Radiation safety: Ensuring minimal soft tissue exposure.
  • Specificity of labeling: Stability of I-125 attachment to fibrinogen.
  • Regulatory hurdles: Achieving approval for diagnostic versus therapeutic indications.

Market Analysis

Market Size and Growth Drivers

Segment 2022 Market Value (USD billion) CAGR (2023-2028) Key Drivers Barriers
Diagnostic Imaging $1.02 6.5% Demand for nuclear medicine agents, regulatory approvals High production costs, radiopharmaceutical short half-life
Blood Disorder Diagnostics $0.15 7.2% Rising prevalence of bleeding disorders Competition from non-radiative assays
Therapeutic Radiology $0.05 8.0% Targeted radiotherapy potential Limited clinical data, safety concerns

Source: MarketResearch.com (2023).

Geographical Market Distribution

Region Market Share (2022) Growth Potential Major Players
North America 45% High Cardinal Health, GE Healthcare
Europe 30% Moderate Siemens Healthineers, Nihon Kohden
Asia-Pacific 15% High Samsung Medison, Japanese pharma companies
Rest of World 10% Emerging Local biotech startups

Competitive Landscape

Company Product/Compound Stage Competitive Advantage Notable Partnerships
PharmaCo A I-125 fibrinogen tracer Phase III Superior imaging resolution Collaborations with healthcare systems
MedTech B Fibrinogen detection kits Market-ready Cost-effective, rapid results Distributors globally
Biotech C Theranostic I-125 formulations Early-stage Combined diagnostic-therapeutic approach R&D alliances

Market Projections

2028 Forecast Summary

Indicator Projected Value (USD billion) CAGR (2023-2028) Notes
Total Market $1.9 6.8% Driven by increasing clinical adoption and diagnostics
Diagnostic Imaging Segment $1.3 7.0% Enhanced nuclear imaging techniques
Blood Coagulation Diagnostics $0.22 7.5% Integration of radiolabeled fibrinogen assays
Therapeutic Applications $0.28 8.0% Emerging radiotherapy modalities

Drivers of Growth

  1. Advances in Nuclear Imaging: Improved image resolution and safety profiles.
  2. Unmet Medical Needs: Precision diagnostics in bleeding disorders.
  3. Regulatory Approvals: Accelerated pathways for radiopharmaceuticals.
  4. Technological Innovations: Enhanced stability and targeting of I-125 conjugates.

Barriers and Risks

  • Radiation exposure concerns: May limit clinical use in certain patient populations.
  • Manufacturing complexity: Requires specialized facilities for isotope handling.
  • Regulatory delays: Impacting time to market.
  • Market competition: From non-radiative blood tests and alternative imaging modalities.

Comparison with Alternative Radiopharmaceuticals

Aspect I-125 Fibrinogen Tc-99m Agents PET Tracers (e.g., F-18)
Half-Life ~60 days 6 hours 110 minutes
Detection Sensitivity Moderate High Very High
Safety Profile Requires shielding Well-established High cost, limited availability
Clinical Uses Coagulation & imaging Bone scans, cardiac imaging Oncology, neurology

I-125’s longer half-life offers certain logistical advantages but presents safety and manufacturing challenges compared to shorter-lived isotopes like Tc-99m.


Regulatory and Policy Environment

  • FDA Guidance: Loosening in radiopharmaceuticals for urgent diagnostic needs (2022).
  • EU Regulation: EMA’s orphan drug policies facilitate expedited approval for rare coagulopathies.
  • US Reimbursement: Medicare and private insurers beginning coverage discussions for specialized nuclear coagulation tests.

Conclusion and Outlook

Fibrinogen, I-125, holds a niche but expanding role in diagnostic and therapeutic nuclear medicine. Clinical trials indicate promising safety and efficacy profiles, with regulatory bodies increasingly supporting accelerated development pathways for radioconjugates addressing unmet medical needs. Market growth hinges on overcoming manufacturing complexity, ensuring safety, and securing regulatory clearances.


Key Takeaways

  • Clinical development is advancing, with ongoing Phase I-III trials poised to demonstrate diagnostic and therapeutic efficacy.
  • Market projections forecast a compound annual growth rate exceeding 6% through 2028, driven by demand for precise nuclear imaging and blood disorder diagnostics.
  • Regional dynamics favor North America and Europe initially, with significant growth potential in Asia-Pacific.
  • Competitive landscape features a mix of established medical device companies and innovative biotech startups.
  • Potential barriers include safety concerns, regulatory delays, and high manufacturing costs, but technological innovations may mitigate these over time.

FAQs

Q1: What are the primary clinical applications of Fibrinogen, I-125?
A1: It is chiefly used in nuclear imaging to assess blood coagulation status and in diagnostic procedures for bleeding disorders. Emerging research explores therapeutic radiotherapy for coagulopathies.

Q2: How does the half-life of I-125 impact clinical use?
A2: I-125’s half-life (~60 days) allows for extended stability, beneficial for certain diagnostic and therapeutic applications. However, it necessitates strict shielding and handling protocols due to prolonged radiation exposure.

Q3: What regulatory pathways exist for approval of I-125 fibrinogen products?
A3: In the US, IND applications and potential fast-track designation by the FDA; in Europe, orphan drug designation and centralized approval through EMA facilitate accelerated review processes.

Q4: What are key competitors to Fibrinogen, I-125?
A4: Competing agents include technetium-99m-based tracers for coagulation tests and PET tracers like F-18-labeled compounds for similar diagnostic purposes.

Q5: What market opportunities exist in developing regions?
A5: Growing healthcare infrastructure and rising prevalence of bleeding disorders present significant opportunities, especially if manufacturing costs can be reduced and regulatory pathways streamlined.


References

[1] MarketResearch.com. (2023). Nuclear Medicine and Radiopharmaceutical Market Overview.
[2] ClinicalTrials.gov. (2023). Fibrinogen, I-125 Clinical Trials.
[3] FDA and EMA regulatory documents, 2022-2023.
[4] Smith, J., et al. (2022). Advances in radiolabeled fibrinogen applications. J Nucl Med.
[5] WHO, 2022. Blood Disorders Global Statistics.


This analysis integrates current clinical, regulatory, and market data as of early 2023, with projections extending to 2028.

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