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.
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.

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
Massachusetts	7
New York	7
Florida	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
National Heart, Lung, and Blood Institute (NHLBI)	4

Sponsor Type

Sponsor Type for Fibrinogen, I-125
Sponsor	Trials
Other	420
Industry	73
NIH	14

Fibrinogen, I-125: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 24, 2026

What is fibrinogen, I-125 and what is it used for?

Fibrinogen, I-125 is a radiolabeled fibrinogen (iodine-125) used for in vivo imaging/quantification of fibrin formation and related thrombotic or coagulation processes, depending on the clinical protocol and label. The product is typically positioned within nuclear medicine and coagulation diagnostics, where radiotracer handling, imaging workflow, and regulatory/quality requirements shape demand.

What is the current clinical-trials status?

No complete, verifiable clinical-trials update can be produced for “fibrinogen, I-125” from the information provided in the prompt. A usable update requires specific trial identifiers (NCT/EudraCT), sponsors, study phases, enrollment status, locations, dates, and endpoints. Without those data, a precise “current status” and “what is read out or ongoing” breakdown cannot be compiled.

What is the market structure for fibrinogen I-125 diagnostics?

Fibrinogen, I-125 sits in the intersection of:

• In vitro coagulation demand drivers (thrombosis risk stratification and anticoagulation management workflows)
• Nuclear medicine demand drivers (imaging capacity, tracer procurement, reimbursement practices, and radiopharmacy supply chains)

Market-adoption constraints that typically govern radiotracer uptake

Demand is not just clinical. It is operational:

• Radiopharmacy supply chain: short half-life logistics, QA release testing, and specialized handling equipment
• Imaging workflow integration: scanner availability, imaging protocol standardization, and interpretive training
• Reimbursement and coding: payment pathways determine testing volume more than clinical interest alone
• Competing modalities: ultrasound, CT angiography, MR, D-dimer pathways, and other nuclear tracers for thrombus imaging

Where fibrinogen, I-125 fits competitively

In practice, the competitive set is driven by the clinical question:

• Diagnosing or localizing active thrombosis: radiotracer-specific protocols vs. ultrasound/CT workflows
• Monitoring coagulation activity: lab coagulation markers and imaging-based alternatives
• Use in specialized centers: uptake clusters where nuclear medicine programs run high tracer volumes

How do pricing and procurement economics affect the addressable market?

Radiopharmaceutical economics often follow:

• Cost per dose and kit economics rather than unit tablets/vials
• Volume discounting for radiopharmacies and large hospital systems
• Reorder cycles tied to tracer production capacity and distribution schedules
• Service economics: the hospital pays for imaging capacity, interpretation, and radiopharmacy readiness in addition to tracer acquisition

For a projection, these economics require actual public inputs (current list price, distribution region, reimbursement rates, and dose utilization). Those inputs are not present in the prompt, so a numeric market forecast cannot be constructed without fabricating facts.

What regulatory and quality factors typically shape supply and scale?

Radiotracers depend on:

• NDA/BLA or equivalent regulatory approvals in each jurisdiction
• Manufacturing practice compliance (sterility, radiochemical purity, identity testing)
• Release and shelf-life constraints that limit geographic reach
• Radiation safety requirements that influence hospital adoption

A market projection requires confirmed label geography, current authorization status, and manufacturing capacity. None of that is provided in the prompt.

Can we produce a market forecast for fibrinogen, I-125 now?

A complete and accurate projection requires:

• baseline sales or doses administered,
• geographic and indication segmentation,
• reimbursement and pricing inputs,
• and competitive share assumptions backed by data.

None of those are supplied. Under these constraints, any numeric projection would be unverifiable and would not meet a “hard data” standard.

Actionable takeaways for investors and R&D planners

Even without a numeric forecast, decision-grade actions can be set up around the known determinants of radiotracer adoption:

• Validate payer coverage and coding pathways for nuclear coagulation/thrombosis indications in target geographies (this typically determines utilization far more than clinical differentiation alone).
• Quantify radiopharmacy readiness at target accounts (equipment availability, staff certification, QA throughput, and tracer handling SOP maturity).
• Map competitive alternatives by diagnostic pathway (US/CT-based algorithms vs. nuclear imaging protocols vs. lab-marker strategies).
• Secure manufacturing and release reliability metrics (radiochemical purity conformity, batch release lead times, and distribution reliability), because supply stability often gates repeat ordering.

Key Takeaways

• Clinical-trials update cannot be completed without trial identifiers and readout status data tied to “fibrinogen, I-125.”
• Market analysis is constrained because the prompt provides no label geography, dosing assumptions, pricing, reimbursement, sales history, or competitive share data.
• Radiotracer uptake is operational and payer-driven: radiopharmacy supply chain, imaging workflow integration, and reimbursement/coding dominate utilization.

FAQs

1. Is fibrinogen, I-125 an imaging agent or a lab diagnostic?
   It is a radiolabeled diagnostic agent used within nuclear medicine workflows for fibrin-related processes, not a standard lab coagulation test.

2. What most strongly influences hospital adoption of radiotracers like fibrinogen, I-125?
   Radiopharmacy supply chain reliability, imaging protocol integration, and reimbursement/coding pathways.

3. What is the typical competitive landscape for thrombus/coagulation nuclear tracers?
   Ultrasound and CT angiography algorithms, lab-marker pathways such as D-dimer strategies, and other thrombus-imaging radiotracers.

4. Why can’t a numeric market forecast be given from the prompt alone?
   A forecast requires baseline sales or utilization data, pricing and reimbursement inputs, and label/geography segmentation that are not provided.

5. What should a diligence plan prioritize for fibrinogen, I-125 development or commercialization?
   Label status and geography, manufacturing/release performance, radiopharmacy channel readiness, and payer coverage evidence tied to specific diagnostic endpoints.

---

References

No sources were provided in the prompt, and no verifiable, citation-ready trial or market facts for “Fibrinogen, I-125” can be cited without external evidence.