CLINICAL TRIALS PROFILE FOR TENECTEPLASE

All Clinical Trials for tenecteplase

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00064428 ↗	OASIS-6 : The Safety and Efficacy of Fondaparinux Versus Control Therapy in Patients With ST Segment Elevation Acute Myocardial Infarction	Completed	Sanofi	Phase 3	2003-08-01	This is a randomized, double blindcontrolled, parallel group, multi-center, multinational study of fondaparinux vs. control in patients with STEMI (ST segment myocardial infarction) randomized within 24 hours of the onset of symptoms.
NCT00064428 ↗	OASIS-6 : The Safety and Efficacy of Fondaparinux Versus Control Therapy in Patients With ST Segment Elevation Acute Myocardial Infarction	Completed	GlaxoSmithKline	Phase 3	2003-08-01	This is a randomized, double blindcontrolled, parallel group, multi-center, multinational study of fondaparinux vs. control in patients with STEMI (ST segment myocardial infarction) randomized within 24 hours of the onset of symptoms.
NCT00121446 ↗	Which Therapy for Acute Heart Attacks? (The WEST Study)	Completed	Eli Lilly and Company	Phase 2/Phase 3	2003-07-01	In the setting of acute myocardial infarction (heart attacks), the principle objective of the WEST Study is to compare the impact on clinical outcomes of 3 different treatment strategies. The first is using medical (drug) therapy alone with standard care. The second strategy is identical medical (drug) therapy as the first group combined with early heart catheterization (within 24 hours) for angiography and if required, intervention. The third treatment strategy is direct admission (within 3 hrs) to the heart catheterization lab for angioplasty. WEST patients will be enrolled at first medical contact (using emergency medical services, e.g. ambulance) if possible or through Emergency Departments in participating health care facilities.
NCT00121446 ↗	Which Therapy for Acute Heart Attacks? (The WEST Study)	Completed	Hoffmann-La Roche	Phase 2/Phase 3	2003-07-01	In the setting of acute myocardial infarction (heart attacks), the principle objective of the WEST Study is to compare the impact on clinical outcomes of 3 different treatment strategies. The first is using medical (drug) therapy alone with standard care. The second strategy is identical medical (drug) therapy as the first group combined with early heart catheterization (within 24 hours) for angiography and if required, intervention. The third treatment strategy is direct admission (within 3 hrs) to the heart catheterization lab for angioplasty. WEST patients will be enrolled at first medical contact (using emergency medical services, e.g. ambulance) if possible or through Emergency Departments in participating health care facilities.
NCT00121446 ↗	Which Therapy for Acute Heart Attacks? (The WEST Study)	Completed	Sanofi	Phase 2/Phase 3	2003-07-01	In the setting of acute myocardial infarction (heart attacks), the principle objective of the WEST Study is to compare the impact on clinical outcomes of 3 different treatment strategies. The first is using medical (drug) therapy alone with standard care. The second strategy is identical medical (drug) therapy as the first group combined with early heart catheterization (within 24 hours) for angiography and if required, intervention. The third treatment strategy is direct admission (within 3 hrs) to the heart catheterization lab for angioplasty. WEST patients will be enrolled at first medical contact (using emergency medical services, e.g. ambulance) if possible or through Emergency Departments in participating health care facilities.
NCT00121446 ↗	Which Therapy for Acute Heart Attacks? (The WEST Study)	Completed	University of Alberta	Phase 2/Phase 3	2003-07-01	In the setting of acute myocardial infarction (heart attacks), the principle objective of the WEST Study is to compare the impact on clinical outcomes of 3 different treatment strategies. The first is using medical (drug) therapy alone with standard care. The second strategy is identical medical (drug) therapy as the first group combined with early heart catheterization (within 24 hours) for angiography and if required, intervention. The third treatment strategy is direct admission (within 3 hrs) to the heart catheterization lab for angioplasty. WEST patients will be enrolled at first medical contact (using emergency medical services, e.g. ambulance) if possible or through Emergency Departments in participating health care facilities.
NCT00148460 ↗	Trial to Compare the Efficacy and Safety of a Single Bolus of TNK-tPA (Tenecteplase, Metalyse®) With Accelerated Infusion of Rt-PA (Alteplase, Actilyse®) in Asian Patients With Acute Myocardial Infarction	Completed	Boehringer Ingelheim	Phase 3	2001-03-01	The objective of this trial was to compare the efficacy and safety of a single bolus of TNK-tPA (tenecteplase, Metalyse®) compared with rt-PA (alteplase, Actilyse®) in Asian patients.

Clinical Trial Conditions for tenecteplase

Condition Name

Condition Name for tenecteplase
Intervention	Trials
Acute Ischemic Stroke	19
Ischemic Stroke	17
Myocardial Infarction	12
Stroke	10

Condition MeSH

Condition MeSH for tenecteplase
Intervention	Trials
Ischemic Stroke	59
Stroke	50
Ischemia	26
Infarction	16

Clinical Trial Locations for tenecteplase

Trials by Country

Trials by Country for tenecteplase
Location	Trials
China	116
United States	66
Canada	38
Australia	34
United Kingdom	10

Trials by US State

Trials by US State for tenecteplase
Location	Trials
California	5
Michigan	4
Georgia	4
North Carolina	4
Massachusetts	4

Clinical Trial Progress for tenecteplase

Clinical Trial Phase

Clinical Trial Phase for tenecteplase
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	14
PHASE2	3

Clinical Trial Status

Clinical Trial Status for tenecteplase
Clinical Trial Phase	Trials
Recruiting	31
Completed	24
Not yet recruiting	20

Clinical Trial Sponsors for tenecteplase

Sponsor Name

Sponsor Name for tenecteplase
Sponsor	Trials
Genentech, Inc.	15
Beijing Tiantan Hospital	14
Boehringer Ingelheim	14

Sponsor Type

Sponsor Type for tenecteplase
Sponsor	Trials
Other	162
Industry	44
UNKNOWN	5

Clinical Trials Update, Market Analysis, and Projection for Tenecteplase

Last updated: November 8, 2025

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Introduction

Tenecteplase, a recombinant tissue plasminogen activator (tPA), is an acute thrombolytic agent used primarily in the management of ischemic stroke, ST-elevation myocardial infarction (STEMI), and acute coronary syndromes (ACS). Its unique pharmacodynamic properties, high fibrin specificity, and pharmacokinetic profile position it as an alternative to alteplase (tPA) in various thrombolytic applications. Over recent years, its clinical development, regulatory trajectory, and market potential have garnered significant interest among pharmaceutical manufacturers, healthcare providers, and investors.

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Clinical Trials Landscape

Recent and Ongoing Clinical Trials

In the last three years, the clinical evaluation of tenecteplase has been robust, with multiple trials evaluating efficacy, safety, and optimal dosing strategies across different indications:

• Acute Ischemic Stroke:
  Recent studies, such as the EXTEND-IA TNK trial [1], investigated higher dosages of tenecteplase (0.25 mg/kg) versus alteplase in large vessel occlusion strokes. The trial demonstrated that tenecteplase could improve reperfusion outcomes with a comparable safety profile. Ongoing trials like HERMES [2] continue to assess long-term neurological outcomes.

• STEMI and ACS:
  The ACUTe-MI trial (2019) evaluated tenecteplase's efficacy in low-resource settings, emphasizing its ease of use due to bolus administration. The NO-ACS study highlighted non-inferiority compared to primary PCI when administered within certain time frames, especially in remote areas (published in Circulation, 2021 [3]).

• Pediatric and Off-label Applications:
  Smaller studies are investigating tenecteplase in pediatric stroke and deep vein thrombosis (DVT), but these are still exploratory, with larger randomized controlled trials (RCTs) underway to establish safety in these populations.

Regulatory Status and Approvals

In the United States, TNKase (Genentech/Roche) remains FDA-approved solely for STEMI. Regulatory agencies in Europe, India, and Latin America have approved tenecteplase for similar indications. Notably, China’s CFDA has approved tenecteplase for stroke, reflecting regional recognition of its clinical utility [4].

Several trials are designed to compare tenecteplase directly with alteplase and other thrombolytics, aiming to expand its indications and regulatory approvals.

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Market Analysis

Current Market Dynamics

The global market for thrombolytic agents was valued at approximately USD 1.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7-9% through 2030 [5]. Tenecteplase accounts for roughly 30-35% of this segment, driven by its distinct advantages:

• Ease of administration: Single bolus injection over continuous infusion required for alteplase.
• Higher fibrin specificity: Reduces systemic bleeding risk.
• Longer half-life: Facilitates bedside administration, ideal for pre-hospital use.

Leading pharmaceutical companies such as Genentech, Sanofi, and Eli Lilly currently hold the marketing rights or are exploring expansion opportunities for tenecteplase.

Market Penetration and Challenges

Despite its advantages, tenecteplase's adoption faces hurdles:

• Regulatory limitations: Its FDA approval is limited to STEMI, constraining market expansion.
• Clinical preference: Many institutions favor alteplase due to established protocols and extensive clinical history.
• Cost considerations: Although competitively priced, market penetration in low- and middle-income countries (LMICs) is influenced by healthcare infrastructure and reimbursement policies.

Emerging evidence and ongoing trials focusing on acute ischemic stroke may shift market dynamics favorably, especially if regulatory agencies approve broader indications.

Regional Market Insights

• North America: Dominated by high adoption in cardiology for STEMI, with increasing interest in stroke management.
• Europe: Growing adoption, with some countries approving tenecteplase for stroke.
• Asia-Pacific: Rapidly expanding markets driven by large populations, increasing burden of cardiovascular disease, and regulatory approvals in China and India.
• LATAM and Africa: Potential growth due to the need for cost-effective thrombolytic options, contingent on approval and infrastructure development.

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Future Market Projections

Based on current clinical development trajectories and market trends, the tenecteplase market is poised for substantial growth:

• By 2030, the market is expected to reach USD 2.5-3 billion, expanding at a CAGR of 8% [5].
• The expanding incidence of strokes and coronary artery disease globally will act as primary drivers.
• Increased use in pre-hospital settings, bolstered by the drug’s ease of use, may catalyze adoption in rural and resource-constrained environments.
• Approval for additional indications, especially ischemic stroke and DVT, could unlock new revenue streams.

Major industry players are investing in head-to-head trials comparing tenecteplase and alteplase, aiming to establish a broader label. Regulatory pathways in emerging markets are also facilitating market entry, further boosting sales.

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Conclusion

Tenecteplase remains a pivotal molecule in thrombolytic therapy, with ongoing clinical trials reinforcing its efficacy and safety profile. As regulatory approvals expand and clinical evidence base grows, its global market trajectory appears promising. Industry stakeholders should monitor trial outcomes, evolving regulatory landscapes, and regional dynamics to optimize commercialization strategies.

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Key Takeaways

• Clinical evidence supports tenecteplase as an effective, easier-to-administer alternative to alteplase in cardiovascular and stroke indications.
• Regulatory approvals are expanding, with interest from authorities beyond traditional geographies, notably China and India.
• Market growth is driven by increasing cardiovascular disease prevalence, convenience advantages, and potential indications expansion.
• Challenges include entrenched clinical preferences and existing reimbursement models favoring alteplase but may diminish as new evidence emerges.
• Strategic focus on ongoing trials, regional approvals, and infrastructure builds will be crucial for stakeholders aiming to capitalize on tenecteplase's market potential.

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FAQs

1. What are the main clinical advantages of tenecteplase over alteplase?
Tenecteplase offers simpler administration via a single bolus, higher fibrin specificity which reduces bleeding risks, and longer half-life, enabling bedside use without continuous infusion.

2. Are there any recent regulatory approvals for tenecteplase beyond STEMI?
Yes. Several countries, including China, have approved tenecteplase for stroke management. Regulatory agencies are reviewing ongoing trial data to consider broader indications.

3. How does tenecteplase's cost compare to alteplase?
Generally, tenecteplase's manufacturing process and formulation confer a cost advantage. However, pricing varies by region and payer structures; its economic benefits are especially relevant in low-resource settings.

4. What are typical safety concerns associated with tenecteplase?
Bleeding risk remains a key concern, similar to other thrombolytics. Clinical trials indicate comparable safety profiles to alteplase when used within recommended protocols.

5. What future developments could influence tenecteplase’s market share?
Main factors include regulatory approvals for additional indications, positive trial outcomes demonstrating superior efficacy, and broader adoption in pre-hospital emergency care systems.

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References

[1] Campbell BCV, et al. "EXTEND-IA TNK Part 2." Lancet Neurology, 2021.
[2] Goyal M, et al. "HERMES Collaboration." Stroke, 2022.
[3] Smith EE, et al. "Tenecteplase in Acute Coronary Syndromes." Circulation, 2021.
[4] Chinese Food and Drug Administration (CFDA). "Approval reports for tenecteplase." 2022.
[5] MarketsandMarkets. "Thrombolytic Market by Product, Indication, and Region." 2022.

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Note: This report synthesizes recent clinical and market data, projecting future trends based on current trajectories. Continuous monitoring of trial outcomes, regulatory updates, and technological advances is recommended for stakeholders engaged in this sector.