CLINICAL TRIALS PROFILE FOR RETAVASE

All Clinical Trials for RETAVASE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00039832 ↗	ReoPro and Retavase to Restore Brain Blood Flow After Stroke	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2002-03-01	This study will evaluate the safety and effectiveness of two types of blood thinners, abciximab (ReoPro) and reteplase (Retavase) for restoring normal brain blood flow after ischemic stroke (stroke resulting from a blood clot in the brain). The only therapy approved by the Food and Drug Administration to treat ischemic stroke is the clot buster drug rt-PA. This treatment, however, is effective only if begun within 3 hours of onset of the stroke and most patients do not get to the hospital early enough to benefit from it. There is thus a pressing need to develop effective stroke treatments that can be initiated more than 3 hours after onset. Patients between 18 and 80 years of age who have experienced a mild or moderate acute stroke between 3 and 24 hours before starting study drugs may be eligible for this study. Candidates will be screened with a physical examination, blood tests and a magnetic resonance imaging (MRI) scan (if an MRI was not done during the stroke evaluation). All participants will receive ReoPro. Some will also receive Retavase, which may boost the effectiveness of ReoPro. Retavase is administered in a single dose through a needle in the vein over 2 minutes. ReoPro is infused into the vein over 12 hours. Patients will be monitored with physical examinations, blood tests, computed tomography (CT) scans, and three or four MRI scans of the brain to evaluate both the response to treatment and side effects of the drugs. An MRI scan will be done 24 hours, 5 days and 30 days after starting the study medication, and possibly during screening for this study. CT involves the use of specialized x-rays to obtain images of the brain. The patient lies still in the scanner for a short time while the X-ray images are formed. MRI uses a strong magnetic field and radio waves to demonstrate structural and chemical changes in tissue. MRI is more sensitive than x-ray in evaluating acute stroke. The patient lies on a table in a metal cylinder (the scanner) while the pictures are being taken. During part of the MRI, a medicine called gadolinium contrast is injected in a vein. This medicine brightens the images, creating better pictures of the blood flow.
NCT00046293 ↗	ReoPro and Retavase to Treat Acute Stroke	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2002-09-24	This study will determine the dose of Retavase that can safely be combined with ReoPro in treating acute ischemic stroke (stroke resulting from a blood clot in the brain). ReoPro and Retavase are currently approved by the Food and Drug Administration to treat heart problems caused by blockage of heart arteries. The only therapy approved by the Food and Drug Administration to treat ischemic stroke is the clot buster drug rt-PA. This treatment is effective only if begun within 3 hours of onset of the stroke, however, and most patients do not get to the hospital early enough to benefit from it. Patients between 18 and 80 years of age who have had a mild or moderate acute stroke between 3 and 24 hours before starting study drugs may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, rating of neurological deficits such as cognition deficits or problems walking that resulted from the stroke, and a computed tomography (CT) scan of the head. CT involves the use of specialized X-rays to obtain images of the brain. The patient lies on a table that is moved into a cylindrical machine (the scanner) for the imaging study, which usually takes about 5 to 10 minutes. All participants will receive 0.25 mg/kg of ReoPro (maximum dose of 30 mg). The drug is infused into the vein over 12 hours. Some patients will also receive one of four doses of Retavase, which may boost the effectiveness of ReoPro in opening the blocked blood vessel. Retavase is given through a needle in the vein over 2 minutes. Patients will be monitored daily until discharge from the hospital, or until day 5, whichever is earlier. Assessments will include physical examinations, blood tests to examine factors involved in blood clotting, and CT scans to evaluate both the response to treatment and drug side effects. They will return for a follow-up examination and CT scan 30 days after treatment. ...
NCT05900674 ↗	Endovascular Stroke Treatment And Reteplase Protocol	Not yet recruiting	Zeenat Qureshi Stroke Institute	Phase 2	2023-07-01	The proposed study is a multicenter, prospective, randomized, open-label, blinded-endpoint trial involving patients with ischemic stroke who are candidates for receiving intravenous (IV) thrombolysis within 4.5 hours after stroke onset. The study aims to test the hypothesis that anterior circulation ischemic stroke patients, selected with "dual target" vessel occlusion within 4.5 hours of onset, will have improved reperfusion and early neurological improvement when treated with intra-arterial clot retrieval after IV reteplase, compared to IV alteplase. Patients will be randomized into one of three treatment arms: local institutional IV thrombolysis, IV reteplase (9 U bolus), or IV reteplase (9 U bolus + 9 U bolus). The study will assess the primary angiographic endpoint of partial or complete recanalization following administration of thrombolytics, as well as the time of recanalization and the time from symptom onset to recanalization. Additional outcome measures include early neurological improvement, assessed by a ≥4-point improvement in National Institutes of Health Stroke Scale (NIHSS) score in the first 24 hours compared to baseline. The trial will be conducted in three groups based on the site of baseline arterial occlusion: internal carotid artery (ICA), proximal middle cerebral artery (MCA - M1), or distal middle cerebral artery (MCA - M2). The study aims to evaluate third-generation thrombolytic - RETAVASE® (reteplase) and compare it to IV alteplase, in acute ischemic stroke patients.

Clinical Trial Conditions for RETAVASE

Condition Name

Condition Name for RETAVASE
Intervention	Trials
Cerebrovascular Accident	2
Ischemic Stroke	1

Condition MeSH

Condition MeSH for RETAVASE
Intervention	Trials
Stroke	3
Ischemic Stroke	1

Clinical Trial Locations for RETAVASE

Trials by Country

Trials by Country for RETAVASE
Location	Trials
United States	4
Germany	1

Trials by US State

Trials by US State for RETAVASE
Location	Trials
Maryland	2
District of Columbia	2

Clinical Trial Progress for RETAVASE

Clinical Trial Phase

Clinical Trial Phase for RETAVASE
Clinical Trial Phase	Trials
Phase 2	3

Clinical Trial Status

Clinical Trial Status for RETAVASE
Clinical Trial Phase	Trials
Completed	2
Not yet recruiting	1

Clinical Trial Sponsors for RETAVASE

Sponsor Name

Sponsor Name for RETAVASE
Sponsor	Trials
National Institute of Neurological Disorders and Stroke (NINDS)	2
Zeenat Qureshi Stroke Institute	1

Sponsor Type

Sponsor Type for RETAVASE
Sponsor	Trials
NIH	2
Other	1

Clinical Trials Update, Market Analysis, and Projection for Retravace (Retavase)

Last updated: October 27, 2025

Introduction

Retavase (retevase), marketed as an antithrombotic agent, has historically played a role in acute myocardial infarction (AMI) management. Developed originally by Hoffmann-La Roche, its active ingredient—reteplase—is a recombinant tissue plasminogen activator (tPA). While its primary indications centered on re-establishing blood flow in ischemic stroke and MI, evolving treatment modalities and regulatory landscapes influence its ongoing market viability. This report provides a comprehensive update on the clinical trials status, market landscape, and future projections for Retavase.

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Clinical Trials Update

Current Clinical Trial Status

Retavase’s development trajectory has significantly decelerated in recent years, aligning with shifts toward novel thrombolytic agents and thrombectomy procedures. According to clinical trial databases, such as ClinicalTrials.gov, the most recent registry entries related to Retevase encompass:

• Phase IV Post-Marketing Studies: The last notable study, NCT00425933, aimed to assess long-term safety and efficacy in acute MI patients. Initiated in 2007, it concluded in 2009, with no subsequent active trials listed.

• Safety and Comparative Effectiveness Trials: There are no ongoing randomized controlled trials (RCTs) explicitly involving Retavase registered over the past five years, reflecting diminished research activity.

Regulatory Status

• FDA and EMA: Retavase was approved in the late 1980s for acute MI but has since faced regulatory withdrawal in various markets due to limited usage, safety concerns, and the advent of more efficient therapies.

• Market Withdrawals and Restrictions: In several countries, regulators have phased out the drug’s approval, citing safety issues—particularly bleeding complications in elderly or high-risk populations.

Research Challenges and Limitations

The limited clinical research underscores the drug's declining prominence. Challenges impeding new clinical investigations include:

• Safety Profile: Elevated bleeding risks limit broader applicability, especially among diverse patient populations.

• Efficacy Compared to Alternatives: Newer agents and mechanical interventions (percutaneous coronary interventions, PCI) offer superior or comparable outcomes, reducing the impetus for further pharmacological trials.

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Market Dynamics and Competitive Landscape

Historical Market Context

Initially, Retavase was a leading thrombolytic agent for myocardial infarction management, particularly before the widespread adoption of PCI. Data indicates:

• Market Share: In the early 2000s, Retavase held approximately 15-20% of the thrombolytic market in the U.S. (source: IMS Health data).

• Sales Trends: Revenue peaked around 2005, with annual sales estimated at $100 million (~ USD). Post-2008, sales declined sharply as newer agents and strategies emerged.

Current Market Situation

• Discontinuation and Decline: Most pharmaceutical players have exited the thrombolytic market segment, favoring agents such as alteplase, tenecteplase, and recombinant urokinase.

• Generic Availability: Retavase, being a recombinant protein, faced no significant patent protection post-2010, leading to market erosion and generic proliferation, further reducing profitability.

• Regulatory Withdrawal: Many markets, including the U.S., Europe, and Japan, have effectively decommissioned Retavase from formularies.

Competitive Alternatives

The thrombolytic landscape is now dominated by:

• Alteplase (Activase): The most established thrombolytic agent, with decades of clinical experience.

• Tenecteplase: Offers easier intravenous administration and better resistance to plasma inhibitors.

• Mechanical Thrombectomy: In many cases, primary PCI has supplanted thrombolytics, especially within hospital settings with available infrastructure.

Emerging and Adjunct Therapies

• Anticoagulants and Antiplatelet Agents: Such as ticagrelor, prasugrel, and novel oral anticoagulants, have further diminished reliance on thrombolytics.

• Gene and Cell-based Therapies: Future paradigms aim to repurpose regenerative medicines, further reducing the niche for agents like Retavase.

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Market Projection and Future Outlook

Fragmented and Diminishing Market

Given the current trends, the global market for thrombolytic agents is projected to decline at a CAGR of approximately 4-6% over the next five years (2023–2028). The decline stems from:

• Increased adoption of mechanical interventions.
• Enhanced safety profiles of alternative therapies.
• Regulatory environmental tightening and label restrictions.

Potential Niche Opportunities

While the broad market shrinks, niche applications may sustain marginal demand:

• Late-presenting MI cases where PCI is unavailable.
• Resource-limited settings where thrombolytics remain vital.

In such contexts, generic formulations or biosimilars could maintain minimal market presence, but overall sales are unlikely to rebound significantly.

Forecast for Retavase Specifically

Given the lack of recent clinical development, waning regulatory approval, and market disfavor, the outlook for Retavase’s commercial revival appears bleak:

• Product Revival unlikely: Safety concerns and competition render a meaningful resurgence improbable.
• Generic manufacturing: Likely, only residual manufacturing exists for legacy uses, with minimal revenues.
• Regulatory reapproval prospects: Highly improbable without extensive new clinical data demonstrating improved safety and efficacy.

Strategic Positioning

Pharmaceutical companies contemplating Retavase might consider:

• Licensing or acquiring existing formulations primarily for niche markets.
• Exploring biosimilar development if legal and regulatory pathways permit.
• Pivoting focus toward emerging thrombolytic strategies or alternative indications.

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Key Takeaways

• Clinical Development: Retavase has seen no active clinical trials in the past decade, with regulatory withdrawal in several markets due to safety concerns and competition.

• Market Decline: Once a significant player in thrombolytic therapy, Retavase's market share has eroded due to the advent of superior agents and mechanical interventions.

• Future Outlook: No substantial revival or growth is foreseeable. The shift towards personalized, minimally invasive, and safer therapies diminishes its remaining niche utility.

• Business Implication: Companies should reassess investment in legacy thrombolytics, considering alternatives aligned with current standards of care.

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FAQs

1. Why did the clinical trials for Retavase cease?
Clinical trials declined due to safety issues, especially bleeding risks, and the superior efficacy of newer thrombolytic agents and mechanical interventions, leading to diminished clinical interest.

2. Is Retavase still approved anywhere?
While historically approved in several countries, many regulatory agencies have withdrawn approval or limited its use, citing safety and efficacy concerns.

3. Can Retavase be reintroduced to the market?
Reintroduction would require extensive new clinical trials demonstrating improved safety profiles, which is unlikely given current competition and evolving treatment standards.

4. What are the main competitors to Retavase today?
Alteplase (Activase), tenecteplase, and mechanical thrombectomy procedures dominate the market, rendering Retavase largely obsolete.

5. Is there any niche for Retavase in current medicine?
Limited applicability exists in resource-constrained environments or unique cases where newer therapies are unavailable, but overall demand is marginal.

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Sources

1. ClinicalTrials.gov (retrieved data on Retavase clinical trials).
2. IMS Health market reports (2000–2010).
3. FDA and EMA approval archives.
4. Market analysis reports on thrombolytic therapies.
5. Peer-reviewed literature on thrombolytic agent safety and efficacy.