CLINICAL TRIALS PROFILE FOR SODIUM HEPARIN

All Clinical Trials for Sodium Heparin

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.
NCT00203580 ↗	Trial of the Effect of Low-Molecular-Weight Heparin (LMWH) Versus Warfarin on Mortality in the Long-Term Treatment of Proximal Deep Vein Thrombosis (DVT) (Main LITE Study)	Completed	Canadian Institutes of Health Research (CIHR)	Phase 4	1994-12-01	The purpose of this study is to assess the long-term treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus the standard care use of intravenous heparin followed by oral warfarin sodium.
NCT00203580 ↗	Trial of the Effect of Low-Molecular-Weight Heparin (LMWH) Versus Warfarin on Mortality in the Long-Term Treatment of Proximal Deep Vein Thrombosis (DVT) (Main LITE Study)	Completed	Dupont Applied Biosciences	Phase 4	1994-12-01	The purpose of this study is to assess the long-term treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus the standard care use of intravenous heparin followed by oral warfarin sodium.
NCT00203580 ↗	Trial of the Effect of Low-Molecular-Weight Heparin (LMWH) Versus Warfarin on Mortality in the Long-Term Treatment of Proximal Deep Vein Thrombosis (DVT) (Main LITE Study)	Completed	LEO Pharma	Phase 4	1994-12-01	The purpose of this study is to assess the long-term treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus the standard care use of intravenous heparin followed by oral warfarin sodium.
NCT00203580 ↗	Trial of the Effect of Low-Molecular-Weight Heparin (LMWH) Versus Warfarin on Mortality in the Long-Term Treatment of Proximal Deep Vein Thrombosis (DVT) (Main LITE Study)	Completed	University of Calgary	Phase 4	1994-12-01	The purpose of this study is to assess the long-term treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus the standard care use of intravenous heparin followed by oral warfarin sodium.

Clinical Trial Conditions for Sodium Heparin

Condition Name

Condition Name for Sodium Heparin
Intervention	Trials
Thrombosis	4
Hemodialysis Complication	3
End Stage Renal Disease	3
Healthy	3

Condition MeSH

Condition MeSH for Sodium Heparin
Intervention	Trials
Thrombosis	10
Acute Kidney Injury	6
Venous Thrombosis	6
COVID-19	5

Clinical Trial Locations for Sodium Heparin

Trials by Country

Trials by Country for Sodium Heparin
Location	Trials
United States	35
Germany	11
Italy	10
Spain	10
Canada	7

Trials by US State

Trials by US State for Sodium Heparin
Location	Trials
New York	6
California	5
Texas	3
Ohio	3
Georgia	2

Clinical Trial Progress for Sodium Heparin

Clinical Trial Phase

Clinical Trial Phase for Sodium Heparin
Clinical Trial Phase	Trials
Phase 4	23
Phase 3	12
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for Sodium Heparin
Clinical Trial Phase	Trials
Completed	43
Unknown status	11
Withdrawn	8

Clinical Trial Sponsors for Sodium Heparin

Sponsor Name

Sponsor Name for Sodium Heparin
Sponsor	Trials
Ain Shams University	4
GlaxoSmithKline	4
Azidus Brasil	4

Sponsor Type

Sponsor Type for Sodium Heparin
Sponsor	Trials
Other	116
Industry	27
NIH	3

Sodium Heparin: Clinical Trials, Market Analysis, and Projections

Introduction to Sodium Heparin

Sodium heparin, a highly sulfated glycosaminoglycan, has been a cornerstone in medical treatment for over 80 years, primarily used as an anticoagulant to prevent blood clots. Its versatility and efficacy have led to its application in various medical conditions, including heart attacks, strokes, and now, potentially, in the treatment of COVID-19.

Clinical Trials Update

Intranasal Heparin Trial (INHERIT)

One of the most significant ongoing clinical trials involving heparin is the INHERIT trial. This trial, conducted by Murdoch Children's, The University of Melbourne, Monash University, and the Northern Hospital, aims to assess the efficacy and safety of intranasal heparin for the treatment of early COVID-19 infection and the prevention of its spread within household contacts. The trial also investigates the effect of heparin on "long COVID" symptoms that persist more than 12 weeks after the initial infection.

Recent studies suggest that heparin binds to the COVID-19 virus, potentially reducing its ability to enter cells, which could be crucial in reducing the virus's multiplication in the early stages of infection[1].

Interstitial Cystitis Trial

Another clinical trial involving heparin is the Phase 2 study evaluating the efficacy and safety of a combination product (VNX001) that includes heparin sodium and lidocaine hydrochloride for the reduction of bladder pain in patients with interstitial cystitis (IC) or bladder pain syndrome (BPS). This study compares VNX001 with its individual components and a placebo, highlighting heparin's potential in treating other medical conditions beyond anticoagulation[4].

Market Analysis

Global Market Size and Growth

The global heparin market has experienced significant growth, driven by various factors. As of 2022, the market size was estimated at USD 7.42 billion and is anticipated to reach USD 10.93 billion by 2030, with a CAGR of 5.05% during the forecast period[3].

By 2025, the market is expected to reach USD 10.04 billion and is projected to grow to USD 14.16 billion by 2030, at a CAGR of 7.12%[5].

Market Drivers

Several factors are driving the growth of the heparin market:

• Rising Prevalence of Chronic Diseases: The increasing incidence of pulmonary embolism, venous thromboembolism, and cardiovascular disorders is a significant driver. The expanding geriatric population, which is more prone to these conditions, further fuels the demand for heparin[3].
• Healthcare Infrastructure and Patient Awareness: Increased expenditure on healthcare infrastructure and rising patient awareness are also boosting the market demand[3].
• Research and Development: The rise in research and development activities, including clinical trials and product innovations, is providing profitable opportunities for market players[3].

Regional Market Analysis

• North America: Currently holds the largest market share due to advanced healthcare infrastructure and high patient awareness[5].
• Asia Pacific: Expected to be the fastest-growing region during the forecast period, driven by emerging economies and increasing healthcare investments[5].

Key Players

Major companies operating in the global heparin market include Opocrin SpA, Baxter International, Aspen Pharmacare Holdings Limited, B Braun Melsungen AG, and Pfizer Inc.[5].

Market Projections

Future Trends and Opportunities

The heparin market is expected to continue its growth trajectory, driven by several factors:

• Technological Advancements: Rising investment in advanced technologies and an increase in research and development activities will provide beneficial opportunities for market growth[3].
• Emerging Markets: The rise in emerging markets, particularly in the Asia Pacific region, will offer significant growth opportunities[3].
• Clinical Trials and Innovations: Ongoing and future clinical trials, such as the INHERIT trial, may expand heparin's application beyond traditional anticoagulation, further boosting market demand[1].

Challenges and Restraints

Despite the positive outlook, the heparin market faces some challenges:

• High Cost Associated: The high cost of heparin, especially in certain formulations, can act as a restraint in some markets[3].
• Supply Chain Disruptions: Historical disruptions, such as those caused by the COVID-19 pandemic, can impact the global supply chain and market growth[5].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the heparin market. Initially, the pandemic disrupted the global supply chain but also highlighted the benefits of heparin in treating COVID-19 patients. Studies have shown that patients hospitalized with COVID-19 who received anticoagulation treatment with heparin had a lower risk of mortality[5].

"A large retrospective cohort study conducted during the pandemic showed lower mortality in COVID-19 patients treated with heparin, even after adjusting for age and gender, oxygen saturation, temperature, and use of concomitant medications"[5].

Key Takeaways

• Clinical Trials: Ongoing trials like the INHERIT trial are exploring heparin's efficacy in treating COVID-19 and other conditions.
• Market Growth: The global heparin market is projected to grow significantly, driven by rising chronic diseases, healthcare infrastructure improvements, and research activities.
• Regional Dynamics: North America currently leads the market, while the Asia Pacific region is expected to be the fastest-growing.
• Challenges: High costs and supply chain disruptions are potential restraints.

FAQs

What is the current global heparin market size?

The global heparin market size is expected to reach USD 10.04 billion in 2025[5].

Which region has the largest share in the global heparin market?

North America currently holds the largest market share in the global heparin market[5].

What are the key drivers of the heparin market growth?

Key drivers include the rising prevalence of chronic diseases, improvements in healthcare infrastructure, increasing patient awareness, and ongoing research and development activities[3].

Which companies are major players in the global heparin market?

Major companies include Opocrin SpA, Baxter International, Aspen Pharmacare Holdings Limited, B Braun Melsungen AG, and Pfizer Inc.[5].

How has the COVID-19 pandemic impacted the heparin market?

The pandemic initially disrupted the supply chain but highlighted heparin's benefits in treating COVID-19 patients, leading to favorable growth during the early pandemic period[5].

Sources

1. Intranasal Heparin Trial (INHERIT) - Murdoch Children's Research Institute.
2. Global Heparin Market Insights, Forecast to 2025 - Vision Research Reports.
3. Global Heparin Market – Industry Trends and Forecast to 2030 - Data Bridge Market Research.
4. Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS - UCSD Clinical Trials.
5. Heparin Market Report | Industry Analysis, Size & Forecast Overview - Mordor Intelligence.

Last updated: 2025-01-05