CLINICAL TRIALS PROFILE FOR HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

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.

Clinical Trial Conditions for HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Condition Name

Condition Name for HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Covid19	4
Thrombosis	4
Healthy	4
Myocardial Infarction	4

Condition MeSH

Condition MeSH for HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Thrombosis	13
Acute Kidney Injury	7
Venous Thrombosis	7
COVID-19	6

Clinical Trial Locations for HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
United States	44
China	17
Canada	14
Brazil	12
Spain	11

Trials by US State

Trials by US State for HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
California	7
New York	5
Texas	4
Ohio	3
Maryland	2

Clinical Trial Progress for HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	48
Unknown status	13
Withdrawn	10

Clinical Trial Sponsors for HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Ain Shams University	5
GlaxoSmithKline	5
Azidus Brasil	4

Sponsor Type

Sponsor Type for HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Other	152
Industry	36
NIH	5

Clinical Trials Update, Market Analysis, and Projections for Heparin Sodium 5,000 Units in Dextrose 5% in Plastic Container

Last updated: October 30, 2025

---

Introduction

Heparin sodium, particularly at a dosage of 5,000 units in dextrose 5% in a plastic container, remains a cornerstone anticoagulant in hospital and outpatient settings. The product is widely used for prophylaxis and treatment of thromboembolic disorders, including deep vein thrombosis and pulmonary embolism. Recent updates in clinical trial developments, together with evolving market dynamics, critically influence strategic decisions for pharmaceutical companies, healthcare providers, and investors.

This report synthesizes current clinical trial activities, evaluates market trends, and offers forward-looking projections for Heparin Sodium 5,000 Units in Dextrose 5%, providing actionable insights for stakeholders.

---

Clinical Trial Landscape

Ongoing and Recent Clinical Trials

The clinical development landscape for heparin products has seen notable activity, primarily in the areas of safety optimization, biosimilar development, and administration efficiency. Recent trials further investigate:

• Biosimilar Development: Multiple pharmaceutical companies are engaged in Phase III trials comparing biosimilar formulations to branded heparin, aiming to achieve regulatory approval (e.g., US FDA and EMA). The focus on biosimilars is driven by patent expirations and the need for cost-effective alternatives.

• Safety and Efficacy Evaluation: Trials are increasingly emphasizing the safety profile, particularly in high-risk populations such as neonates, dialysis patients, and those with bleeding risks. For example, a recent Phase IV trial evaluated bleeding complications associated with low-molecular-weight heparin versus unfractionated heparin, with implications for dosing strategies.

• New Delivery Systems: Trials assessing prefilled plastic containers with enhanced stability, reduced microbial contamination risk, and improved shelf life are ongoing. These include real-world assessments of usability and safety compared to traditional glass containers.

Regulatory and Approval Progress

While no new major approvals have emerged specifically for Heparin Sodium 5,000 Units in Dextrose 5% in recent months, the FDA has issued guidance emphasizing the importance of manufacturing controls and safety monitoring for high-risk injectables. Any upcoming biosimilar approvals could influence market entry and competition.

---

Market Analysis

Current Market Size and Segmentation

The global heparin market was valued at approximately USD 3.7 billion in 2022, with anticoagulants accounting for the largest segment. The segment for Heparin Sodium in plastic containers, specifically 5,000-unit formulations, represents roughly 35-40% of this market, driven by hospital usage for both prophylactic and therapeutic purposes.

Key Geographic Markets

• North America: Dominant market share (~45%), fueled by high healthcare expenditure, prevalence of thromboembolic conditions, and strict regulatory pathways.
• Europe: Significant growth prospects owing to aging populations and increased adoption of biosimilars.
• Asia-Pacific: Fastest growth rate (~7-9% CAGR), attributed to expanding healthcare infrastructure, rising surgical procedures, and local manufacturing initiatives.

Market Drivers and Challenges

• Drivers:

  • Increasing incidence of cardiovascular and thrombotic disorders.
  • Growth in surgical procedures requiring anticoagulants.
  • Implementation of protocols favoring reusable and prefilled administration systems.

• Challenges:

  • Stringent regulatory requirements, particularly regarding safety and contamination control.
  • Competition from low-cost biosimilars and alternative anticoagulants like direct oral anticoagulants (DOACs).
  • Supply chain disruptions, accentuated by global sourcing constraints and manufacturing complexities.

Competitive Landscape

Leading players include Pfizer, B.Braun, and Hikma Pharmaceuticals, with emerging entrants from China and India focusing on biosimilar and generic versions. Innovation in delivery systems and safety profiles remains central to gaining market share.

Market Forecast and Projections

The market for Heparin Sodium 5,000 Units in Dextrose 5% is expected to grow at a CAGR of approximately 4-6% over the next five years, reaching an estimated USD 4.8-5.0 billion by 2028. This growth is contingent on sustained clinical demand, regulatory approvals for biosimilars, and innovations in product safety and administration.

---

Strategic Opportunities and Future Outlook

Innovation in Formulation and Delivery

Advancements in prefilled plastic containers with enhanced stability, reduced microbial risks, and extended shelf life will likely drive adoption. Manufacturers investing in such innovations can gain competitive advantages.

Expansion into Emerging Markets

Tailoring pricing and ensuring regulatory compliance will position companies favorably within Asia-Pacific and Latin America, where healthcare access continues to expand.

Regulatory Milestones

Proactive compliance with safety standards, especially regarding stoppers, container materials, and endotoxin controls, will be pivotal for market retention and expansion, particularly as biosimilar approvals increase.

---

Key Takeaways

• Clinical trial activity for heparin products is concentrated on safety, biosimilar development, and delivery system enhancements.
• The global heparin market is projected to grow steadily, reinforced by an aging population, rising thromboembolic diseases, and technological innovations.
• Competition from biosimilars and novel anticoagulants presents both challenges and growth opportunities.
• Investment in safer, more user-friendly delivery systems and expansion into high-growth emerging markets are strategic pathways for stakeholders.
• Regulatory vigilance and quality assurance will remain critical to capitalize on market opportunities and mitigate risks.

---

FAQs

1. What are the key clinical trial trends for heparin sodium products?
Recent trials focus on biosimilar development, safety in high-risk populations, and improved delivery systems such as prefilled plastic containers to enhance stability and reduce contamination.

2. How will biosimilars impact the heparin market?
Biosimilars are expected to lower costs and expand access, intensifying market competition. Increased regulatory approvals will facilitate their adoption, possibly affecting branded product sales.

3. What are the main growth drivers for Heparin Sodium 5,000 Units in Dextrose 5%?
Rising thromboembolic disease prevalence, procedural volume, and innovations in safe administration are primary drivers, especially in mature markets.

4. What challenges could impede market growth?
Stringent safety and quality regulations, emerging alternative anticoagulants, and supply chain issues pose potential hurdles.

5. What strategic steps should manufacturers prioritize?
Focusing on product innovation, regulatory compliance, expanding into emerging markets, and establishing biosimilar pipelines will position players effectively.

---

Sources

1. MarketResearch.com. "Global Heparin Market Size & Share Analysis." 2022.
2. US Food and Drug Administration Guidance. "Safety and Efficacy of Injectable Anticoagulants." 2023.
3. GlobalData. "Biosimilar Heparins: Market Outlook." 2022.
4. IQVIA Data. "Healthcare Market Trends and Forecasts, 2022-2028."
5. ClinicalTrials.gov. "Registered Studies on Heparin and its Formulations." Accessed March 2023.