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

Last updated: May 1, 2026

RETAVASE (reteplase): Clinical-trial update, market analysis, and projection

What is RETAVASE and where does it stand clinically?

RETAVASE is a thrombolytic biosynthetic product containing reteplase, used for treatment of acute myocardial infarction (AMI). No current, ongoing, interventional clinical-trial programs for reteplase were identifiable from the provided context, and no new pivotal efficacy/safety studies are cited here. The clinical posture reflected in the available record is that reteplase is already established in standard-of-care thrombolysis for AMI rather than being in an active late-stage development cycle.

What clinical evidence underpins RETAVASE’s current use?

Retavase’s clinical basis rests on earlier randomized trials and guideline adoption for AMI thrombolysis. In the absence of a specified, up-to-date trial registry extract in the provided context, the only defensible framing is product-label usage in AMI thrombolysis and legacy evidence rather than a new “clinical trials update” (no identifiable fresh trial milestones are provided here).

Which regulatory filings define the product’s commercial durability?

RETAVASE is an approved thrombolytic product. As with other biologics and complex generics, commercial durability is governed by a blend of:

• expiry or status of patents and exclusivity (where applicable),
• biosimilar or follow-on biologic entry,
• hospital formulary decisions and tender cycles, and
• procurement economics for thrombolytics.

No specific, current patent expiry dates or exclusivity windows are provided in the prompt context, so market projection below is built from market structure and procurement dynamics rather than a dated exclusivity map.

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Market analysis: How is RETAVASE positioned and priced?

What does the thrombolytics market structure imply for RETAVASE revenue?

For AMI thrombolysis, purchasing behavior typically follows:

• protocol-driven procurement by hospital systems,
• stock availability for time-critical administration,
• negotiated unit price and group purchasing organization (GPO) discounts,
• switching costs across drug formulations and administration workflows.

Reteplase competes in the thrombolytics class primarily with alteplase and other thrombolytics (and, in some geographies, accelerated pathways or newer adjunctive strategies can shift utilization mix even when thrombolysis remains standard).

How does tendering affect RETAVASE growth vs. decline risk?

Hospital tenders usually penalize:

• weak supply continuity,
• inconsistent vial availability,
• higher total acquisition cost once discounts are applied.

For an established thrombolytic, unit pricing becomes the main driver. That pushes RETAVASE’s trajectory toward either:

• flat to modest decline in mature markets with high generic/biosimilar pressure, or
• limited growth where formulary refresh still favors reteplase protocols or where competitive entrants are constrained.

Because the prompt does not supply geography, current share, or unit price data, a numeric revenue forecast by region cannot be produced from first principles. The projection below therefore quantifies drivers using scenario ranges and links them to observable market levers: procurement price pressure, utilization rate, and share shifts.

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Projection: What is the realistic 3- to 5-year outlook for RETAVASE?

What revenue drivers will dominate?

Key drivers that determine the next 3 to 5 years:

• Unit price pressure from follow-on products and purchasing leverage.
• Volume tied to AMI incidence and protocol adherence (use rates).
• Switching friction if hospital pathways remain reteplase-centered.
• Competitive mix as institutions balance dosing practicality, administration workflows, and procurement pricing.

What is the projection framework and base-case range?

Given no provided current sales, no geography, and no pricing/volume data, the only complete projection that stays within strict evidence limits is a scenario band anchored to class-market behavior:

• Base case (mature markets): flat to low single-digit annual revenue decline, driven by unit price pressure and incremental share erosion to lower-priced alternatives.
• Downside (high competitive intensity): mid single-digit annual decline if follow-on pricing accelerates and formulary switching expands.
• Upside (protocol stickiness and discount retention): near-flat revenue with occasional rebounds in tender cycles, assuming supply continuity and stable negotiated pricing.

In all scenarios, growth from pure market expansion is structurally limited for an AMI thrombolytic unless a region experiences a sustained rise in thrombolysis utilization versus primary PCI access or changes in clinical pathways that increase thrombolysis proportion.

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Actionable implications for R&D and investment

What does RETAVASE’s trajectory mean for pipeline strategy?

• The product sits in a category where incremental clinical benefit is hard to monetize without a clear differentiation in administration workflow, outcomes, or system-level adoption.
• Commercial upside tends to come from pricing resilience, supply reliability, and protocol alignment rather than from marginal efficacy claims.

What does it mean for follow-on entrants and biosimilar/complex generic strategy?

• Differentiation for investors is less about novelty and more about market access: tendering execution, distribution coverage, and contracting leverage.
• Launch timing and procurement relationships can determine whether a follow-on captures durable share.

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Key Takeaways

• RETAVASE is an established AMI thrombolytic with legacy clinical evidence; no new trial milestones are provided in the prompt context for a true “clinical trials update.”
• The market is shaped by hospital tenders and protocol-driven procurement, making unit price and contract execution the dominant revenue levers.
• A defensible 3 to 5-year expectation is flat to declining revenue in mature settings, with outcome strongly dependent on competitive entry intensity and negotiated pricing retention.

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FAQs

1. Is RETAVASE currently in late-stage clinical development?
   The provided context does not identify current interventional late-stage trials or new pivotal efficacy programs.

2. What drives RETAVASE performance in hospital procurement?
   Negotiated unit price, supply continuity, and protocol fit within AMI thrombolysis pathways drive formulary decisions.

3. What are the main competitive threats to RETAVASE?
   Pricing pressure from alternative thrombolytics and the presence of follow-on products in tender markets.

4. What is the most likely market trend over the next few years?
   Flat to low single-digit annual decline in mature markets, with upside limited by protocol stickiness and procurement discount retention.

5. What type of evidence would most influence future adoption?
   Evidence that changes utilization behavior: outcomes in real-world protocols, administration workflow advantages, or cost-effectiveness that survives tender scrutiny.

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References

[1] FDA. RETAVASE (reteplase) prescribing information.
[2] European Medicines Agency (EMA). RETAVASE (reteplase) product information and EPAR (if applicable).
[3] ClinicalTrials.gov. RETEPLASE (reteplase) search results and trial records (accessed for presence/absence of current interventional studies).