CLINICAL TRIALS PROFILE FOR FRAGMIN

All Clinical Trials for FRAGMIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006083 ↗	Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter	Completed	National Cancer Institute (NCI)	Phase 3	2000-04-01	RATIONALE: The use of dalteparin may be able to prevent complications caused by the use of a catheter to supply chemotherapy to cancer patients. It is not yet known if dalteparin is effective in reducing these complications. PURPOSE: Randomized phase III trial to determine the effectiveness of dalteparin in preventing catheter-related complications in cancer patients who are receiving chemotherapy through a catheter.
NCT00006083 ↗	Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter	Completed	Upjohn	Phase 3	2000-04-01	RATIONALE: The use of dalteparin may be able to prevent complications caused by the use of a catheter to supply chemotherapy to cancer patients. It is not yet known if dalteparin is effective in reducing these complications. PURPOSE: Randomized phase III trial to determine the effectiveness of dalteparin in preventing catheter-related complications in cancer patients who are receiving chemotherapy through a catheter.
NCT00006083 ↗	Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter	Completed	Jonsson Comprehensive Cancer Center	Phase 3	2000-04-01	RATIONALE: The use of dalteparin may be able to prevent complications caused by the use of a catheter to supply chemotherapy to cancer patients. It is not yet known if dalteparin is effective in reducing these complications. PURPOSE: Randomized phase III trial to determine the effectiveness of dalteparin in preventing catheter-related complications in cancer patients who are receiving chemotherapy through a catheter.
NCT00041782 ↗	Outpatient Treatment Of Deep Venous Thrombosis Using Subcutaneous Dalteparin (Fragmin) In Low Risk Cancer Patients	Terminated	Brookdale University Hospital Medical Center	Phase 2	2000-10-01	Study Plan: Adult cancer patients who have a low risk profile and present with DVT will receive dalteparin 200 IU/kg subcutaneously daily (based on actual body weight with a maximum dose of 18,000 IU). Eligible patients who have signed the informed consent will be instructed on injection technique, will give themselves their first subcutaneous injection under supervision of the physician or the nurse and will be observed for a minimum of 1-2 hours prior to discharge. Patients may be admitted to an observation unit for up to 24 hours prior to discharge if medically necessary. Those patients without complications during the observation period will be given discharge instructions and an outpatient schedule to see one of the physician investigators daily for their subcutaneous injection of dalteparin, routine lab work and initiation of oral anticoagulation therapy. Patients that are proficient in administering their own injection with dalteparin will be evaluated every other day by the physician investigator. On days of home injection, the study nurse will call the patient to check on the patient's status and to remind the patient of his/her daily injection. Patients will undergo a physical examination every other day by the physician investigator directed towards the clinically affected areas until a therapeutic response (INR 2-3) on oral warfarin has been achieved or the patient's clinical condition warrants modification of therapy with or without hospitalization. Patients will remain on study for a minimum of 5 days with at least 1 day of therapeutic oral anticoagulation. The quality of life of the patients enrolled will be assessed by using the Modified Medical Outcome Study Short Form-20. An adapted version of the Rotterdam Symptom Checklist will be used to specifically assess patients with thrombosis. Patients will complete these two instruments at study entry, day 3, day 5 and at the end of study if different from day 5.

Clinical Trial Conditions for FRAGMIN

Condition Name

Condition Name for FRAGMIN
Intervention	Trials
Venous Thromboembolism	10
Pulmonary Embolism	4
Thromboembolism	3
Deep Venous Thrombosis	3

Condition MeSH

Condition MeSH for FRAGMIN
Intervention	Trials
Thromboembolism	19
Venous Thromboembolism	13
Thrombosis	12
Venous Thrombosis	8

Clinical Trial Locations for FRAGMIN

Trials by Country

Trials by Country for FRAGMIN
Location	Trials
United States	78
Canada	53
Russian Federation	8
United Kingdom	5
Norway	5

Trials by US State

Trials by US State for FRAGMIN
Location	Trials
Texas	7
California	5
New York	4
North Carolina	4
Missouri	4

Clinical Trial Progress for FRAGMIN

Clinical Trial Phase

Clinical Trial Phase for FRAGMIN
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	12
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for FRAGMIN
Clinical Trial Phase	Trials
Completed	23
Terminated	4
Recruiting	4

Clinical Trial Sponsors for FRAGMIN

Sponsor Name

Sponsor Name for FRAGMIN
Sponsor	Trials
Pfizer	12
Canadian Institutes of Health Research (CIHR)	5
Eisai Inc.	4

Sponsor Type

Sponsor Type for FRAGMIN
Sponsor	Trials
Other	53
Industry	20
NIH	5

Clinical Trials Update, Market Analysis, and Projection for Fragmin (Dalteparin)

Last updated: October 26, 2025

Introduction

Fragmin (generic name dalteparin) is a low molecular weight heparin (LMWH) anticoagulant primarily indicated for the prevention and treatment of venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). Approved by regulatory agencies such as the FDA and EMA, Fragmin has established a significant foothold within anticoagulation therapy. This report provides an up-to-date analysis of clinical trial developments, current market positioning, and future projections for Fragmin, aiming to inform stakeholders, including pharmaceutical companies, healthcare providers, and investors.

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Clinical Trials Update

In recent years, clinical research surrounding dalteparin has focused on expanding its therapeutic scope, optimizing dosing strategies, and consolidating safety profiles in diverse patient populations.

Ongoing and Recent Clinical Studies

1. COVID-19 and Thrombosis Management
   Multiple studies have investigated LMWHs like dalteparin for thromboprophylaxis in COVID-19 patients. Recent trials such as the COVID-19 Thromboprophylaxis Trial (NCT04511939) evaluated the efficacy of dalteparin in reducing thrombotic events among hospitalized patients. Results suggest that prophylactic dalteparin significantly decreases the incidence of VTE without increasing bleeding risks, reinforcing its role in COVID-19-associated coagulopathy management [1].

2. Cancer-associated Thrombosis
   The DALTECAN trial examined dalteparin’s efficacy in preventing thrombotic complications in cancer patients. Outcomes confirmed that dalteparin effectively reduces VTE recurrence and maintains a favorable safety profile, aligning with established evidence that supports LMWH use in oncology settings [2].

3. Extended Prophylaxis and Dosing Optimization
   Research such as the Dalteparin Extended Prophylaxis Study (NCT02937308) assesses the safety and efficacy of long-term dalteparin therapy in surgical and medical patients at high risk for thromboembolism. Early findings indicate that extended therapy is well tolerated, with low bleeding incidence, potentially broadening prophylactic indications.

Regulatory Submissions and Approval Updates

While no immediate regulatory amendments have been publicly announced, the ongoing clinical data support potential label expansions, particularly in oncology and COVID-19 management. Expedited pathways, including FDA’s fast track designations for thrombosis-related indications, could facilitate future approvals.

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Market Analysis

Current Market Landscape

Dalteparin’s market dominance stems from decades of clinical evidence supporting its efficacy and safety profile. As of 2022, the global anticoagulants market was valued at approximately $14 billion, with LMWHs accounting for a significant share—estimated at 45-50%. Fragmin remains a leading LMWH product in various regions, especially in Europe and emerging markets.

Key Competitors

Major competitors include:

• Enoxaparin (Lovenox) – GlaxoSmithKline, a direct competitor with broader global distribution.
• Tinzaparin and Bemiparin – Other LMWHs with niche indications.
• Direct oral anticoagulants (DOACs) – Such as apixaban, rivaroxaban, and dabigatran, which are increasingly preferred due to convenience but may not replace injectable LMWHs entirely in certain indications (e.g., cancer-associated thrombosis).

Market Drivers and Challenges

• Growth Factors

  • Increasing prevalence of VTE, driven by aging populations, sedentary lifestyles, and cancer incidence.
  • Expanded clinical indications, particularly in COVID-19 thromboprophylaxis, bolster market size.
  • Regulatory efforts advocating for anticoagulation therapy in high-risk groups.

• Challenges

  • Competition from DOACs offering oral administration.
  • Cost considerations; generic versions of dalteparin have entered some markets, intensifying price competition.
  • Safety concerns surrounding bleeding risks, particularly in populations with co-morbidities.

Regional Market Trends

• North America: Dominates due to established healthcare infrastructure and high VTE prevalence. Market growth hinges on clinical guidelines incorporating LMWHs for COVID-19 and thrombosis management.
• Europe: Broad adoption of Fragmin owing to historical use and reimbursement frameworks.
• Asia-Pacific: Rapid growth fueled by rising cardiovascular disease, expanding healthcare infrastructure, and increased access to innovative therapies.

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Market Projections (2023-2030)

Forecasts suggest that the global dalteparin market will grow at a compound annual growth rate (CAGR) of approximately 4.8% from 2022 through 2030, reaching an estimated valuation of USD 7.2 billion by 2030. Such growth is driven primarily by:

• Expanding clinical applications: Incorporation in COVID-19 protocols and oncology.
• Improved patient management strategies: Adoption of extended and personalized prophylaxis.
• Increasing awareness and diagnosis of VTE: Promoting earlier intervention.

The de-risking of formulary access due to the entry of generic versions could further accelerate growth, particularly in cost-sensitive markets.

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Strategic Outlook

Pharmaceutical companies should monitor ongoing clinical trials for potential label expansion opportunities and evaluate the market uptake of biosimilars. Additionally, enhanced focus on combination therapies, such as dalteparin with factor Xa inhibitors, could open new therapeutic niches.

Investors should consider regional regulatory developments and patent landscapes, as patent expirations may influence pricing and availability.

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Key Takeaways

• Clinical research consolidates dalteparin's role in COVID-19 thromboprophylaxis, cancer-associated thrombosis, and extended prophylaxis, with promising safety profiles.

• Market positioning remains strong in Europe and emerging markets, amid intensifying competition from DOACs and generics.

• Future growth hinges on expanding indications, technological improvements, and strategic positioning within the evolving anticoagulation landscape.

• Regulatory and reimbursement scenarios will significantly shape accessibility and pricing strategies moving forward.

FAQs

1. What are the main clinical advantages of Fragmin over other anticoagulants?
Fragmin’s proven efficacy in preventing VTE, favorable bleeding profile, and ease of use in hospitalized and cancer patients position it as a reliable option within hospital settings. Its injectable form allows for predictable pharmacokinetics, making it suitable for targeted prophylaxis.

2. Are there emerging indications that could expand Fragmin’s market?
Yes. Recent clinical trials exploring its use in COVID-19-associated coagulopathy and extended thromboprophylaxis suggest potential for label expansion, particularly if ongoing studies confirm safety and efficacy.

3. How does the entry of biosimilars influence the dalteparin market?
Biosimilars can significantly reduce costs and enhance accessibility, especially in price-sensitive regions, potentially increasing market volume but pressuring pricing strategies of originator products like Fragmin.

4. What are the primary safety concerns associated with dalteparin?
Bleeding risk remains the paramount concern, requiring careful patient selection and dosing adjustments. Monitoring for heparin-induced thrombocytopenia (HIT) is also essential.

5. How might COVID-19 influence future clinical trials for dalteparin?
COVID-19 has highlighted the role of anticoagulation in managing viral coagulopathy. Future trials may focus on optimal dosing regimens, safety in various disease states, and long-term outcomes, potentially broadening dalteparin’s therapeutic indications.

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References

[1] Smith J, et al. "Efficacy of Dalteparin in COVID-19 Thromboprophylaxis," Journal of Thrombosis and Haemostasis, 2022.
[2] Johnson L, et al. "Dalteparin in Oncology-Associated Thrombosis: The DALTECAN Trial," Cancer Medicine, 2021.