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: July 30, 2026

RETAVASE (reteplase) clinical trials update, market analysis, and revenue projection

Executive summary: Retavase (reteplase) is a legacy thrombolytic for acute myocardial infarction. Its clinical development pipeline is inactive in most geographies, with no major new pivotal trials dominating recent public records. Commercial trajectory is driven by guideline adoption cycles, hospital procurement dynamics, and competition from alteplase (tPA) and tenecteplase, plus broader use of adjunct antiplatelet and reperfusion pathways. For near-to-medium-term revenue projection, the base case is a low-growth, offsetting environment: steady but mature volume, modest price pressure, limited new uptake, and continued substitution within fibrinolysis. Without a current, regulator-facing development program, incremental upside is mainly tied to geographic mix, contracting, and lifecycle optimization rather than new labels.

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What is Retavase (reteplase) and where does it sit in today’s thrombolytic market?

Answer: Retavase is a recombinant plasminogen activator indicated for thrombolysis in acute myocardial infarction, administered as a bolus (two-dose regimen) versus longer infusion for some comparators.

Key therapeutic positioning

• Class: Thrombolytic (plasminogen activator).
• Target condition: Acute myocardial infarction (primary/early thrombolysis setting as used in contemporary reperfusion pathways).
• Practical differentiator: Bolus administration supports ease of use in emergency workflows.

Competitive set that shapes pricing and volume

• Alteplase (tPA): Broad hospital familiarity; varied dosing/administration models.
• Tenecteplase: Often preferred for logistical advantages and protocol fit in many systems.
• Adjunct standard of care: Antiplatelets, anticoagulants, and reperfusion timing protocols influence overall utilization of any thrombolytic.

Market dynamics that matter for forecasting

• Procedure substitution: Primary PCI availability and regional EMS pathways reduce fibrinolytic use.
• Guideline refresh cycles: Tend to favor agents with administration simplicity or evidence aligned with system protocols.
• Procurement contracting: Volume often shifts between products based on tender pricing and supply reliability more than on clinical differentiation.

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What clinical trials exist for reteplase now, and what is the latest update?

Answer: Public-facing, late-stage reteplase development activity is limited. The product is primarily supported by established efficacy/safety evidence rather than new, label-changing pivotal trials in the modern era.

How to interpret “clinical trials update” for Retavase

For mature, marketed thrombolytics, “update” typically means:

• New subgroup analyses in published literature rather than new FDA labels
• Bioequivalence or formulation work in select jurisdictions
• Local bridging studies tied to commercialization in specific markets

What usually does not drive near-term value for reteplase

• New Phase 3 programs seeking broader indications, because incremental differentiation versus tenecteplase and alteplase is challenging for legacy agents without differentiated delivery systems.
• Expanded dosing regimens that would require new outcomes evidence and regulator review.

Practical implication for projection

Clinical trial velocity is not a primary driver of near-term revenue for Retavase. The dominant drivers are market access, contracting, substitution patterns, and guideline implementation.

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How strong is the patent and exclusivity position for Retavase (reteplase)?

Answer: Reteplase is a legacy biologic-like protein product; U.S. exclusivity and patent protection (where any still exists) generally does not prevent market competition for years after initial approval, so the market behaves like a mature, contract-driven segment rather than a protected niche.

What usually determines competitive entry risk

• Patent estate coverage for the active protein
• Formulation or manufacturing process patents (if any still active in a given jurisdiction)
• Regulatory exclusivity attached to the reference listing in the relevant country

Why this matters for market forecasting

When protection is not a primary barrier, pricing pressure increases and revenue depends on:

• Tender inclusion
• Hospital formulary placement
• Supply continuity
• Competitive interchangeability at the point of care

(A specific patent-by-patent listing cannot be produced here without an Orange Book / jurisdictional patent audit for the exact reference product and market authorization records.)

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What is the FDA regulatory status of Retavase and what does it imply for access?

Answer: Retavase is an FDA-approved thrombolytic with established labeling. In mature therapeutic areas, regulatory status mainly affects:

• Whether the reference product is still preferred in formularies
• Whether competing versions can market and substitute

How regulatory status impacts revenue projections

• If competitive versions are available and substitutable in formularies, share loss is driven by contracting cycles.
• If additional label restrictions exist (not expected for widely used, mature indications), they could slow substitution.

(A precise current Orange Book status listing and associated FDA data cannot be compiled here without the current FDA database pull for the specific product code and applicant history.)

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When does Retavase lose exclusivity and when do generics or biosimilars become relevant?

Answer: For legacy reteplase products, the competitive “exclusivity-to-entry” window has largely passed in most markets. Current market behavior reflects substitution through procurement rather than a single near-term exclusivity event.

Generic/biosimilar relevance

• Reteplase is a protein drug; competition mechanisms vary by jurisdiction and regulatory framework.
• In practice, replacement decisions in hospitals reflect availability and price relative to alternative thrombolytics.

Projection implication

Base-case forecasts should model a mature market with:

• Low or negative price growth
• Share changes among thrombolytics based on contracting and system-level adoption of tenecteplase or PCI strategies

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How does Retavase compare with alteplase and tenecteplase in adoption and procurement?

Answer: Retavase’s bolus dosing supports workflow simplicity, but adoption is constrained by broader system preference and procurement outcomes where tenecteplase and alteplase are entrenched.

Decision factors hospitals use

• Administration logistics: bolus vs infusion time and staffing
• Clinical protocol alignment: local guideline adoption and EMS workflow
• Tender economics: unit price and contract terms
• Supply assurance: ability to deliver during high-demand periods

What drives share shifts

• Switches happen when:
  • A competing agent is priced lower under tender
  • Formularies standardize around a single thrombolytic
  • Tenecteplase becomes system-default under protocol simplification

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What patent litigation affects Retavase (reteplase) and competitive entry?

Answer: No current, widely documented, label-blocking litigation can be reliably summarized here for Retavase without a live docket and jurisdictional review.

What litigation would matter for revenue

• Injunction risk affecting supply or sales of a competing product
• Settlement-based “carve-outs” that delay entry
• Exclusivity determinations tied to regulatory submissions

(A litigation map requires docket-level sources, which are not included in this response.)

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What formulations and manufacturing IP barriers exist for reteplase products?

Answer: For mature protein thrombolytics, manufacturing and formulation differences typically govern comparability rather than enabling strong brand differentiation, unless process IP materially impacts yield, stability, or stability under transport/storage constraints.

Typical manufacturing sensitivity for forecasting

• Stability under cold chain
• Reconstitution workflow tolerability
• Batch-to-batch consistency that affects procurement trust

Market effect

If multiple suppliers exist, procurement increasingly emphasizes price and reliability over non-clinical differentiation.

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What does a market projection for Retavase look like?

Answer: A defensible projection model for Retavase assumes a mature thrombolytic segment with:

• Gradual global volume decline tied to PCI growth in many regions
• Limited gains from workflow-driven selection
• Ongoing unit price pressure as procurement favors lower-cost alternatives

Base-case projection framework (structure)

Revenue = (Eligible patient volume) × (Fibrinolysis share) × (Retavase share within thrombolytics) × (Net realized price)

Key drivers:

1. PCI expansion rate reduces the eligible fibrinolysis pool.
2. Thrombolytic substitution shifts share toward tenecteplase or whichever product is contracted.
3. Net price declines with tender competition and inflation mismatch.
4. Geographic mix can offset global decline if Retavase retains share in lower-PCI or constrained-resource settings.

Scenario outline

• Base case: Low-single-digit negative revenue growth in real terms; flat nominal in contracting-stable markets.
• Downside: Faster fibrinolysis displacement by PCI plus stronger tender-driven substitution accelerates share loss and price erosion.
• Upside: Retavase retains or gains share where bolus protocols and formulary preferences favor it; supply disruptions among competitors temporarily support pricing.

What investors should watch

• Hospital group tender cycles by region
• Substitution trends: tenecteplase preference by protocol
• Reimbursement changes that alter net realized price
• Consistent supply availability and distribution performance

(Quantified forecasts in absolute dollars or units cannot be produced without an input dataset: current sales baseline by geography and product, competitor share, and net price history.)

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Competitive landscape: which companies contest Retavase share in thrombolysis?

Answer: Competition is principally within thrombolytics, dominated by portfolio-level supply and contracting, where tenecteplase and alteplase suppliers seek default formulary status.

How to map competitive pressure without litigation data

• Identify contracted thrombolytics in major hospital systems
• Track procurement tenders for MI thrombolysis
• Compare unit price, shelf life, and supply reliability

(A company-by-company “who holds what share” table requires current market share sources not provided here.)

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Key takeaways

• Retavase is a mature thrombolytic where clinical trial momentum is not the main value driver; procurement and system-level adoption dominate.
• Market outcomes depend on PCI displacement of fibrinolysis, thrombolytic substitution toward tenecteplase-aligned protocols, and net price pressure.
• A practical revenue projection uses a patient-volume and share-based framework rather than relying on new pivotal development.

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FAQs

1) What is the current clinical trial status of reteplase?

Public, label-changing Phase 3 development for reteplase is not a prominent driver in recent records; activity is typically limited to non-pivotal or jurisdiction-specific work.

2) Why do hospitals choose tenecteplase over Retavase?

Protocol standardization, ease of administration, tender pricing, and default formulary decisions often favor tenecteplase.

3) Does bolus administration give Retavase an adoption advantage?

It can support emergency workflows, but adoption is still governed by system tenders and default thrombolytic selection.

4) What would cause a sudden revenue rebound for Retavase?

Supply constraints for competing thrombolytics, favorable tender outcomes, or reimbursement and formulary changes that restore share.

5) How sensitive is Retavase revenue to PCI penetration?

High in many regions: as PCI access increases, the pool eligible for fibrinolysis generally shrinks, reducing addressable demand.

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References (APA)

1. FDA. (n.d.). Drug approval and labeling resources. U.S. Food and Drug Administration. https://www.fda.gov
2. EMA. (n.d.). Medicines information and EPAR database. European Medicines Agency. https://www.ema.europa.eu