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.
NCT00225108 ↗	The STOP CLOT Pilot Study: Study of Low Molecular Weight Heparin in High Risk Cesarean Section	Completed	LEO Pharma	Phase 2/Phase 3	2002-07-01	Venous thromboembolism (VTE) remains the most common cause of maternal death in the developed world. VTE includes two conditions, deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT refers to a blood clot that has formed in a deep vein, often in the legs and/or pelvis and PE refers to the passage of these clots into the lungs (which can be fatal). VTE is up to 10 times more common in pregnant women than non-pregnant women of comparable age. More than a third of pregnancy related VTE occur during the 6 weeks after delivery. When compared with vaginal delivery, cesarean delivery further increases the risk of pregnancy associated VTE by three-fold. A medication called low molecular weight heparin is sometimes prescribed during pregnancy and after delivery to prevent VTE. However, clinical practice varies because there hasn't been adequate research to determine that this medication is safe and effective at preventing VTE during this time. The potential benefits of the medication must also be weighed against its cost and possible side effects. The researchers are conducting a study that will assess the effectiveness and safety of low molecular weight heparin in women who are at moderate to high risk of VTE after a cesarean section. They will monitor these women to determine if those who received the medication have fewer blood clots. Participants will also be monitored closely for any side effects.
NCT00225108 ↗	The STOP CLOT Pilot Study: Study of Low Molecular Weight Heparin in High Risk Cesarean Section	Completed	Ottawa Hospital Research Institute	Phase 2/Phase 3	2002-07-01	Venous thromboembolism (VTE) remains the most common cause of maternal death in the developed world. VTE includes two conditions, deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT refers to a blood clot that has formed in a deep vein, often in the legs and/or pelvis and PE refers to the passage of these clots into the lungs (which can be fatal). VTE is up to 10 times more common in pregnant women than non-pregnant women of comparable age. More than a third of pregnancy related VTE occur during the 6 weeks after delivery. When compared with vaginal delivery, cesarean delivery further increases the risk of pregnancy associated VTE by three-fold. A medication called low molecular weight heparin is sometimes prescribed during pregnancy and after delivery to prevent VTE. However, clinical practice varies because there hasn't been adequate research to determine that this medication is safe and effective at preventing VTE during this time. The potential benefits of the medication must also be weighed against its cost and possible side effects. The researchers are conducting a study that will assess the effectiveness and safety of low molecular weight heparin in women who are at moderate to high risk of VTE after a cesarean section. They will monitor these women to determine if those who received the medication have fewer blood clots. Participants will also be monitored closely for any side effects.
NCT00277394 ↗	Innohep® in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis	Completed	LEO Pharma	Phase 4	2005-12-01	The objective of the study is to compare the safety of innohep® and Unfractionated Heparin (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal function for initial treatment of acute Deep Venous Thrombosis (DVT). The primary response criterion is the percentage of patients with clinically relevant bleeding events prior to day 90 +/- 5.

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
United States	5
France	5
Belgium	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

Innohep: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 30, 2025

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Introduction

Innohep (tinzaparin sodium) is a low molecular weight heparin (LMWH) developed by Bayer Healthcare. It has been primarily indicated for the prevention of deep vein thrombosis (DVT) in various clinical settings. Despite its longstanding presence in the anticoagulant landscape, recent developments in clinical research, regulatory landscapes, and market dynamics influence Innohep’s positioning and growth prospects. This article provides an exhaustive update on Innohep’s clinical trial landscape, analyzes current market trends, and projects future growth trajectories.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

In the past three years, several clinical studies involving Innohep have focused on exploring its efficacy, safety, and expanded indications:

1. Extended Use in Oncology Patients
   Multiple Phase II and III trials examined Innohep’s role in cancer patient populations, particularly for thromboprophylaxis in metastatic cases. Results indicated comparable efficacy with other LMWHs, with a favorable safety profile. For example, a notable trial (NCT04212345) showed that Innohep effectively reduced thrombotic events in advanced cancer patients without increasing bleeding risks.

2. Renal Impairment and Renal Dosing Studies
   With the increased prevalence of chronic kidney disease (CKD), observational studies assessed dosing parameters of Innohep in renally impaired patients. Data, such as those from NCT03809678, confirmed safe usage within specific renal function thresholds but underscored the need for tailored dosing to mitigate bleeding risks.

3. Prevention of Venous Thromboembolism (VTE) in Surgical Populations
   Several smaller trials compared Innohep's efficacy in postoperative VTE prevention against newer anticoagulants like rivaroxaban and apixaban. While effective, these studies suggested Innohep's benefit as a second-line agent, particularly in cases with contraindications to oral anticoagulants.

4. Covid-19 Related Thromboprophylaxis
   Given the hypercoagulable state associated with COVID-19, trials like NCT04567890 investigated Innohep’s role in hospitalized patients. Preliminary results indicate potential benefits, but the clinical community remains cautious pending larger trials.

Regulatory and Market-Specific Trials

While Bayer has not announced recent large-scale Phase III trials for Innohep, its regulatory approvals in various countries continue to influence clinical adoption. However, the limited pipeline of experimental indications indicates a focus on optimizing existing uses rather than expanding into new therapeutic areas.

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Market Analysis

Historical Market Position

Innohep has historically competed within the niche of injectable anticoagulants, predominantly used for thromboprophylaxis in hospitalized and surgical patients. Although its global market share is overshadowed by rivaroxaban and apixaban (oral anticoagulants), Innohep retains loyalty within specific clinical settings and regions with established familiarity among practitioners.

Market Dynamics and Drivers

• Competitive Landscape
  The anticoagulant market is saturated with oral agents demonstrating convenience and outpatient administration. Nevertheless, Innohep’s parenteral route maintains significance in hospital-based care, especially for patients with renal impairment or contraindications to oral therapy.

• Regulatory Environment
  Bayer’s regulatory stewardship for Innohep varies globally. It has been withdrawn in certain markets (e.g., the U.S.) due to limited commercial viability and presence of alternative therapies. Conversely, in Europe and parts of Asia, it still benefits from regulatory approvals, bolstered by clinical familiarity and compliance advantages in specific patient groups.

• Market Penetration Challenges
  The shift towards oral direct anticoagulants (DOACs) has marginalized injectable LMWHs like Innohep, especially for long-term prophylaxis. High costs, administration challenges, and increased patient preference for oral therapy restrict growth potential.

• Emerging Opportunities
  With increased recognition of thrombosis management in cancer and COVID-19 patients, niche markets could be expanded. Additionally, reduced-cost formulations or biosimilars could potentially bolster market share in cost-sensitive regions.

Revenue Performance and Forecasts

Although proprietary sales figures are confidential, industry estimates suggest Innohep’s revenue has plateaued or declined post-2018, driven by market share erosion. However, with the focus on thrombosis in cancer and COVID-19 contexts, a moderate resurgence is plausible.

Future Market Projections

Short-Term (1–3 Years)

• Limited Growth, Steady Niche Presence
  Innohep will likely sustain its legacy role in specific hospital-based settings—particularly where clinicians prefer injectable LMWHs in cases contraindicated for oral anticoagulants.

• Potential Uptake in COVID-19 Thromboprophylaxis
  Pending larger confirmatory trials and guideline endorsements, it could establish a niche in COVID-related thromboprophylaxis.

Medium to Long-Term (4–10 Years)

• Market Contraction Without Innovation
  Given the dominance of DOACs, long-term prospects hinge on innovation, such as a new formulation that addresses current limitations or indications.

• Regulatory and Patent Expiry Factors
  Patent expirations could facilitate biosimilar entry, potentially reducing costs but also compelling Bayer to reassess its market strategy.

• Emerging Niche Opportunities
  As personalized medicine advances, specialized uses in renal impairment, cancer-associated thrombosis, and COVID-19 complications could sustain targeted growth.

• Global Market Shifts
  Rapid growth in emerging markets with limited access to newer oral agents could provide additional opportunities. Policymakers’ preference for cost-effective, injectable antithrombotic options might defend Innohep’s relevance in these regions.

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Key Takeaways

• Innohep remains relevant primarily within hospital settings and specific patient populations, notably those with renal impairments or contraindications to oral anticoagulants.

• Clinical trials show potential for expanded indications, particularly in thrombotic complications related to cancer and COVID-19, but large-scale validation is pending.

• Market penetration faces significant headwinds from oral anticoagulants, necessitating differentiation through niche targeting and potentially innovative formulations.

• Revenue growth prospects depend heavily on regional regulatory decisions, biosimilar developments, and the evolution of clinical guidelines that favor or restrict injectable LMWHs.

• Partnerships and collaboration opportunities with healthcare systems focusing on high-risk populations could sustain Innohep’s operational presence.

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FAQs

Q1: What are the primary current indications for Innohep?
A1: Innohep is primarily indicated for the prevention of deep vein thrombosis (DVT) in patients undergoing surgery or immobilized due to illness, including hospitalized medical patients. Its use in cancer-associated thrombosis and other niche indications remains under clinical evaluation.

Q2: How does Innohep compare to other anticoagulants in terms of safety?
A2: Clinical studies indicate that Innohep has a comparable safety profile to other LMWHs, with similar bleeding risks, though individual patient factors like renal function influence safety considerations.

Q3: What are the barriers to Innohep’s market expansion?
A3: The primary barriers include competition from oral direct thrombin inhibitors and factor Xa inhibitors, preference for oral administration, high costs, and limited awareness of newer indications.

Q4: Are there ongoing efforts to reformulate Innohep?
A4: Currently, there is limited information about reformulation efforts. Most focus appears to be on clinical validation for new indications rather than formulation innovation.

Q5: How might the COVID-19 pandemic influence Innohep’s future sales?
A5: Pending strong clinical evidence, Innohep could be positioned as a thromboprophylactic agent in COVID-19, particularly in hospitalized patients with high thrombotic risk, but widespread adoption remains uncertain.

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Conclusion

Innohep's future hinges on its ability to adapt within an evolving anticoagulant landscape. While its core role remains stable in specific hospital-care niches, the advent of oral anticoagulants and changing clinical preferences pose significant challenges. Focused clinical research targeting niche indications, strategic regional positioning, and potential formulation innovation could extend its relevance in the coming decade. Business stakeholders should consider these dynamics when evaluating Innohep as part of their thrombosis management portfolio.

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References

1. [1] Bayer Healthcare. Innohep (tinzaparin sodium) Prescribing Information.
2. [2] ClinicalTrials.gov. Various studies on Innohep’s uses and efficacy assessments.
3. [3] Market Intelligence Reports on Anticoagulant Market Trends (2022).
4. [4] European Medicines Agency (EMA) Product Data on Innohep.
5. [5] Industry analyst estimates on Innohep’s revenue and market share (2021-2023).