CLINICAL TRIALS PROFILE FOR INNOHEP

All Clinical Trials for INNOHEP

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00203658 ↗	Assessment of Long-Term Out-of-Hospital Treatment of Patients With Proximal Deep Vein Thrombosis (DVT) Using Low-Molecular-Weight Heparin (LMWH) Versus LMWH Followed by Warfarin	Completed	Canadian Institutes of Health Research (CIHR)	Phase 4	1997-04-01	The purpose of this study is to assess the long-term out-of-hospital treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus low-molecular-weight heparin followed by warfarin sodium.
NCT00203658 ↗	Assessment of Long-Term Out-of-Hospital Treatment of Patients With Proximal Deep Vein Thrombosis (DVT) Using Low-Molecular-Weight Heparin (LMWH) Versus LMWH Followed by Warfarin	Completed	Dupont Applied Biosciences	Phase 4	1997-04-01	The purpose of this study is to assess the long-term out-of-hospital treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus low-molecular-weight heparin followed by warfarin sodium.
NCT00203658 ↗	Assessment of Long-Term Out-of-Hospital Treatment of Patients With Proximal Deep Vein Thrombosis (DVT) Using Low-Molecular-Weight Heparin (LMWH) Versus LMWH Followed by Warfarin	Completed	LEO Pharma	Phase 4	1997-04-01	The purpose of this study is to assess the long-term out-of-hospital treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus low-molecular-weight heparin followed by warfarin sodium.
NCT00203658 ↗	Assessment of Long-Term Out-of-Hospital Treatment of Patients With Proximal Deep Vein Thrombosis (DVT) Using Low-Molecular-Weight Heparin (LMWH) Versus LMWH Followed by Warfarin	Completed	University of Calgary	Phase 4	1997-04-01	The purpose of this study is to assess the long-term out-of-hospital treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus low-molecular-weight heparin followed by warfarin sodium.

Clinical Trial Conditions for INNOHEP

Condition Name

Condition Name for INNOHEP
Intervention	Trials
Venous Thromboembolism	4
Deep Vein Thrombosis	3
Thromboembolism	3
Pulmonary Embolism	2

Condition MeSH

Condition MeSH for INNOHEP
Intervention	Trials
Thromboembolism	8
Venous Thrombosis	7
Thrombosis	7
Venous Thromboembolism	6

Clinical Trial Locations for INNOHEP

Trials by Country

+

−

Trials by Country for INNOHEP
Location	Trials
Spain	17
Canada	10
France	5
United States	5
Sweden	2

Trials by US State

+

−

Trials by US State for INNOHEP
Location	Trials
New York	1
North Carolina	1
Vermont	1
New Hampshire	1
Illinois	1

Clinical Trial Progress for INNOHEP

Clinical Trial Phase

Clinical Trial Phase for INNOHEP
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for INNOHEP
Clinical Trial Phase	Trials
Completed	13
Not yet recruiting	4
Unknown status	3

Clinical Trial Sponsors for INNOHEP

Sponsor Name

Sponsor Name for INNOHEP
Sponsor	Trials
LEO Pharma	11
Ottawa Hospital Research Institute	3
University of Calgary	2

Sponsor Type

Sponsor Type for INNOHEP
Sponsor	Trials
Other	30
Industry	13
NIH	1

Clinical Trials, Market Analysis, and Projections for INNOHEP (Tinzaparin Sodium)

Introduction

INNOHEP, also known as tinzaparin sodium, is a low molecular weight heparin (LMWH) used primarily for the treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE). Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Efficacy and Safety

INNOHEP has been extensively studied in clinical trials to evaluate its efficacy and safety compared to unfractionated heparin (UFH) and other anticoagulants. In a randomized, multicenter, double-blind trial, INNOHEP was compared to UFH in 435 hospitalized patients with symptomatic DVT, with or without PE. The results showed that INNOHEP administered subcutaneously once daily at a dose of 175 IU/kg was as effective as UFH in preventing thromboembolic events, with no significant difference in the 90-day cumulative thromboembolic event rate[1][3].

Comparison with Warfarin

A randomized trial also compared the efficacy and safety of tinzaparin with warfarin for the treatment of acute, symptomatic venous thromboembolism. Patients receiving tinzaparin showed similar efficacy to those on warfarin, with the added benefit of a simpler dosing regimen without the need for regular INR monitoring[4].

Renal Impairment and Hemodialysis

Clinical studies have highlighted the importance of renal function in patients treated with INNOHEP. Patients with severe renal impairment exhibited a 24% reduction in tinzaparin sodium clearance, and those undergoing hemodialysis showed a prolonged half-life of anti-Xa activity. This suggests that dose adjustments may be necessary in patients with significant renal impairment[1].

Adverse Events

Common adverse events associated with INNOHEP include local reactions at the injection site, such as mild irritation, pain, hematoma, and ecchymosis. Other adverse events include thrombocytopenia, elevations in serum aminotransferases, and hypersensitivity reactions. However, these events are generally reversible and not commonly severe[1][3].

Market Analysis

Global Heparin Anticoagulant Market

The global heparin anticoagulant market is projected to grow significantly, driven by several key factors. By 2031, the market is expected to reach $17.3 billion, growing at a CAGR of 4.5% over the forecast period. The low molecular weight heparin (LMWH) segment, which includes INNOHEP, accounts for the largest share of the total heparin market and is anticipated to grow at the fastest rate[2].

End Users and Geography

Hospitals dominate the heparin anticoagulant market due to the intravenous administration of heparin for treating venous thromboembolism (VTE). However, assisted living facilities are expected to witness the fastest growth rate in the near future. Geographically, North America and Europe are the leading regions, but the Asia Pacific region is predicted to witness the fastest growth rate during the forecast period[2].

Market Drivers

The growth of the heparin anticoagulant market is driven by several factors, including the increasing elderly population, rising incidence of cancer and associated clotting disorders, and the growing volume of surgical procedures. Additionally, the need for secondary prevention of cardiovascular diseases such as coronary artery disease and heart failure contributes to the market's expansion[2].

Market Projections

Future Growth

The global heparin anticoagulant market is expected to continue its upward trend, driven by unmet needs and the increasing prevalence of conditions requiring anticoagulation therapy. The introduction of newer anticoagulants has not significantly displaced heparin and LMWH in most medical procedures, ensuring a stable market position for INNOHEP and similar drugs[2].

Competitive Landscape

Major competitors in the global heparin market include Aspen Pharmacare Holdings Ltd., Baxter International, Inc., Dr. Reddy’s Laboratories Ltd., GlaxoSmithKline plc, and Leo Pharma A/S, among others. These companies are continually innovating and expanding their product portfolios to meet the growing demand for anticoagulant therapies[2].

Key Takeaways

• Efficacy and Safety: INNOHEP has been shown to be as effective as UFH in clinical trials for treating DVT and PE, with a simpler dosing regimen.
• Renal Considerations: Patients with severe renal impairment may require dose adjustments due to reduced clearance of tinzaparin sodium.
• Market Growth: The global heparin anticoagulant market is projected to reach $17.3 billion by 2031, driven by increasing demand and unmet needs.
• End Users: Hospitals currently dominate the market, but assisted living facilities are expected to grow rapidly.
• Geographical Trends: The Asia Pacific region is predicted to witness the fastest growth rate during the forecast period.

FAQs

What is INNOHEP used for?

INNOHEP (tinzaparin sodium) is used for the treatment of acute symptomatic deep vein thrombosis (DVT) with or without pulmonary embolism (PE).

How is INNOHEP administered?

INNOHEP is administered subcutaneously once daily at a dose of 175 IU/kg based on body weight.

What are the common adverse events associated with INNOHEP?

Common adverse events include local reactions at the injection site, thrombocytopenia, elevations in serum aminotransferases, and hypersensitivity reactions.

How does INNOHEP compare to warfarin in clinical trials?

INNOHEP has been shown to be as effective as warfarin in preventing thromboembolic events, with the added benefit of a simpler dosing regimen without the need for regular INR monitoring.

What is the projected growth of the global heparin anticoagulant market?

The global heparin anticoagulant market is expected to reach $17.3 billion by 2031, growing at a CAGR of 4.5% over the forecast period.

Which segment dominates the heparin anticoagulant market?

The low molecular weight heparin (LMWH) segment, which includes INNOHEP, accounts for the largest share of the total heparin market.

Sources

1. Innohep® Rx only (tinzaparin sodium injection) - FDA Label[1]
2. Global Heparin Anticoagulant Market - iHealthcareAnalyst[2]
3. Innohep Rx only (tinzaparin sodium injection) - FDA Label[3]
4. Tinzaparin vs Warfarin for Treatment of Acute Venous Thromboembolism - JAMA[4]