CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%

All Clinical Trials for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000468 ↗	Myocardial Infarction Triage and Intervention Project (MITI)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1988-04-01	To determine the practicality, benefit, and safety of paramedic administration of thrombolytic therapy for acute myocardial infarction. The feasibility of paramedics correctly identifying candidates for thrombolytic therapy following myocardial infarction was assessed in Phase I. In Phase II, pre-hospital thrombolytic therapy was compared with in-hospital thrombolytic therapy.
NCT00000468 ↗	Myocardial Infarction Triage and Intervention Project (MITI)	Completed	University of Washington	Phase 3	1988-04-01	To determine the practicality, benefit, and safety of paramedic administration of thrombolytic therapy for acute myocardial infarction. The feasibility of paramedics correctly identifying candidates for thrombolytic therapy following myocardial infarction was assessed in Phase I. In Phase II, pre-hospital thrombolytic therapy was compared with in-hospital thrombolytic therapy.
NCT00182143 ↗	PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)	Completed	Australian and New Zealand Intensive Care Society Clinical Trials Group	Phase 3	2006-05-01	The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.
NCT00182143 ↗	PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)	Completed	Canadian Critical Care Trials Group	Phase 3	2006-05-01	The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.
NCT00182143 ↗	PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)	Completed	Canadian Institutes of Health Research (CIHR)	Phase 3	2006-05-01	The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.
NCT00182143 ↗	PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)	Completed	McMaster University	Phase 3	2006-05-01	The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.

Clinical Trial Conditions for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%

Condition Name

Condition Name for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%
Intervention	Trials
Thrombosis	4
Myocardial Infarction	4
Healthy	4
Covid19	4

Condition MeSH

Condition MeSH for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%
Intervention	Trials
Thrombosis	13
Acute Kidney Injury	7
Venous Thrombosis	7
COVID-19	6

Clinical Trial Locations for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%

Trials by Country

Trials by Country for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%
Location	Trials
United States	44
China	17
Canada	14
Brazil	12
Spain	11

Trials by US State

Trials by US State for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%
Location	Trials
California	7
New York	5
Texas	4
Ohio	3
North Carolina	2

Clinical Trial Progress for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%

Clinical Trial Phase

Clinical Trial Phase for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%
Clinical Trial Phase	Trials
Completed	48
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%

Sponsor Name

Sponsor Name for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%
Sponsor	Trials
GlaxoSmithKline	5
Ain Shams University	5
Azidus Brasil	4

Sponsor Type

Sponsor Type for Heparin Sodium 12,500 Units In Sodium Chloride 0.9%
Sponsor	Trials
Other	152
Industry	36
NIH	5

Heparin Sodium 12,500 Units in Sodium Chloride 0.9%: Clinical Trials, Market Overview, and Future Outlook

Last updated: February 4, 2026

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What is the current status of clinical trials for Heparin Sodium 12,500 Units in Sodium Chloride 0.9%?

Heparin Sodium 12,500 Units in Sodium Chloride 0.9% (hereafter "Heparin 12,500U") is an injectable anticoagulant. As of Q1 2023, there are no ongoing Phase III clinical trials registered publicly for Heparin 12,500U alone at ClinicalTrials.gov. Historically, the drug has relied on existing approvals for broader heparin products, with the main clinical activities involving safety and efficacy monitoring for specific indications like deep vein thrombosis, pulmonary embolism, and acute coronary syndromes.

Key points:

• No active Phase III trials specifically targeting Heparin 12,500U.
• Some Phase I/II studies or registries used for dose validation, though publicly limited.
• The drug's safety profile established, but optimization of dosing specific to the 12,500U formulation remains an area of ongoing research.

How does the regulatory landscape affect the development of Heparin 12,500U?

In the U.S., the FDA classifies heparin products under the Federal Drug Administration’s (FDA) Biological License Application (BLA) process, typically requiring comprehensive clinical data demonstrating safety and efficacy for specific indications.

• The USFDA has historically approved heparin through an Abbreviated New Drug Application (ANDA) pathway, focusing on bioequivalence and manufacturing consistency.
• No recent (last five years) FDA-approved new molecular entities (NMEs) for Heparin 12,500U.
• In the EU, the European Medicines Agency (EMA) follows a similar generic approval route; the focus remains on manufacturing quality and bioequivalence.

This regulatory context indicates that further development and clinical trials are necessary for a distinct indication or formulation approval. Contract research institutions and major manufacturers control the pipeline, with some imported or compounded versions used off-label.

What is the market size for Heparin Sodium 12,500 Units?

The global heparin market reached approximately USD 4.3 billion in 2022, with an annual growth rate of around 5%. Heparin Sodium 12,500U is a standard dosage unit used primarily in hospitals and clinics for IV anticoagulation.

Market segmentation:

Segment	Share (%)	Key Countries	Value (USD millions)
Healthcare (Hospitals)	70	U.S., Europe, China	3,010
Blood products	15	U.S., Japan	645
Surgical procedures	15	U.S., Germany, South Korea	645

Major manufacturers:

• Pfizer (now part of Pfizer-BioNTech following acquisitions)
• B. Braun Melsungen AG
• Sanofi
• Pfizer’s stock of heparin products remains dominant in the U.S.

Distribution channels:

• Hospital pharmacies
• Direct procurement from manufacturers
• Distributors in emerging markets

Market drivers and constraints

• Drivers: Increase in cardiovascular disease, rising surgical procedures, expanding healthcare infrastructure in Asia-Pacific.
• Constraints: Stringent regulatory approvals, high competition from low-cost generics, supply chain disruptions affecting raw heparin sources.

Market projection and growth outlook through 2030

Driven by trends in anticoagulation therapy and emergency medicine, the global heparin market is projected to grow at a CAGR of 5.2% from 2023 to 2030, reaching approximately USD 6.4 billion.

Factors influencing growth:

• Aging populations in developed countries
• Increasing prevalence of stroke, MI, and thrombotic conditions
• Expansion into emerging markets with growing healthcare investments
• Potential biosimilar and generic entrants expanding access

Potential impact of new formulations or branded products:

Innovation in delivery or safety features could stimulate market expansion, although additional clinical development is necessary to establish such products.

What is the outlook for Heparin Sodium 12,500 Units in the next five years?

• It will largely remain a standard dosage form in established markets.
• Market expansion hinges on regulatory approval for novel indications or formulations.
• Part of the broader heparin component market, which benefits from continued demand but faces pressure on pricing and supply chain stability.

Key takeaways

• No active late-stage clinical trials specific to Heparin Sodium 12,500U; its safety profile is well established from broader heparin data.
• Market size is significant, with around USD 3 billion in current value, driven by hospital use.
• Growth prospects remain steady with a CAGR of around 5%, influenced by aging populations and surgical volume increases.
• Regulatory pathways favor generic and biosimilar development, limiting new branded entries.
• The competitive landscape favors established manufacturers with robust supply chains and manufacturing capacity.

FAQs

1. Is Heparin Sodium 12,500 Units available as a generic or branded product?
Yes, most formulations, including 12,500U, are available as generics under various brand names, especially in North America and Europe.

2. Are there new clinical indications for Heparin Sodium 12,500 Units?
No, recent approved indications remain standard anticoagulation uses. Future indications depend on further clinical trials.

3. How does supply chain stability affect the market?
Heparin manufacturing relies on porcine intestinal raw materials. Disruptions in supply have previously caused shortages, impacting pricing and availability.

4. What role does biosimilar development play?
Biosimilars can lower costs and expand access but face regulatory hurdles. Their entry could alter market dynamics significantly.

5. What are the main challenges facing Heparin Sodium 12,500 Units?
Regulatory complexity, supply chain vulnerability, competition from generics, and evolving safety standards.

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Sources:

[1] IQVIA, "Global Markets for Anticoagulants," 2022.
[2] ClinicalTrials.gov, "Heparin-related Clinical Trials," 2023.
[3] Markets and Markets, "Heparin Market," 2023.