CLINICAL TRIALS PROFILE FOR RETEPLASE

All Clinical Trials for reteplase

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.
NCT00046228 ↗	A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse)	Completed	Eli Lilly and Company	Phase 3	2002-08-01	The purpose of this study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention.
NCT00046228 ↗	A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse)	Completed	Centocor, Inc.	Phase 3	2002-08-01	The purpose of this study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention.
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. ...
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.

Clinical Trial Conditions for reteplase

Condition Name

Condition Name for reteplase
Intervention	Trials
Cerebrovascular Accident	2
Acute ST-segment Elevation Myocardial Infarction	1
Catheter Occlusion	1
Ischemic Stroke	1

Condition MeSH

Condition MeSH for reteplase
Intervention	Trials
Stroke	4
Infarction	3
Myocardial Infarction	3
Ischemic Stroke	2

Clinical Trial Locations for reteplase

Trials by Country

Trials by Country for reteplase
Location	Trials
United States	50
China	22
Argentina	5
Spain	3
Belgium	2

Trials by US State

Trials by US State for reteplase
Location	Trials
District of Columbia	3
Maine	2
Illinois	2
Florida	2
Delaware	2

Clinical Trial Progress for reteplase

Clinical Trial Phase

Clinical Trial Phase for reteplase
Clinical Trial Phase	Trials
Phase 3	6
Phase 2	3

Clinical Trial Status

Clinical Trial Status for reteplase
Clinical Trial Phase	Trials
Completed	4
Not yet recruiting	3
Recruiting	2

Clinical Trial Sponsors for reteplase

Sponsor Name

Sponsor Name for reteplase
Sponsor	Trials
National Institute of Neurological Disorders and Stroke (NINDS)	2
Chiesi Farmaceutici S.p.A.	2
Beijing Tiantan Hospital	1

Sponsor Type

Sponsor Type for reteplase
Sponsor	Trials
Industry	8
Other	3
NIH	2

Reteplase: Clinical Trials Update, Market Analysis, and Projection

Last updated: February 20, 2026

What is the current status of clinical trials for reteplase?

Reteplase is a recombinant plasminogen activator used for thrombolytic therapy, primarily in acute myocardial infarction (AMI). Multiple clinical trials have validated its efficacy and safety profile since approval. The last major trial, the GUSTO-2 trial, reported in 1993, demonstrated that reteplase significantly improved reperfusion rates.

Recent activity includes phase IV post-marketing studies focusing on expanding indications and comparing reteplase with newer thrombolytics. No active phase I, II, or III trials are ongoing globally, as the drug's primary approval in the 1990s has shifted to post-marketing surveillance and comparative effectiveness studies in specific populations.

Summary of Clinical Trial Status:

Trial Phase	Number of Active Trials	Focus Area	Notable Dates
Phase I/II	0	N/A	Completed long ago
Phase III	0	N/A	No new trials reported
Phase IV	Multiple ongoing/regulatory	Safety, efficacy in new populations	Ongoing post-marketing studies

Major new trials are absent due to the availability of alternative thrombolytics and adoption of percutaneous coronary intervention (PCI).

How has the market for reteplase evolved?

Reteplase markets predominantly in hospitals and emergency care settings for acute MI management. Its market share has diluted over the past decade because of several factors:

• Preference for PCI over thrombolytics in many regions.
• The introduction of newer agents with improved profiles.

Market size and revenue:

• The global thrombolytic drugs market was valued at approximately USD 2.1 billion in 2022.
• Reteplase held an estimated 15-20% market share before 2010.
• Current estimates suggest a decline to near 10% or less, equating to USD 200-300 million annually.

Geographical distribution:

Region	Market Share (Estimated)	Key Competitors
North America	40%	Alteplase, tenecteplase
Europe	30%	Alteplase, tenecteplase
Asia-Pacific	20%	Alteplase, urokinase
Latin America	10%	Alteplase

Competitive landscape:

• Alteplase (tPA): Dominates with a larger market share.
• Tenecteplase: Gaining ground due to ease of administration.
• Urokinase: Less used but still present in some regions.

What are the projections for reteplase's market future?

Market forecasts predict continued decline for reteplase, driven by shifts toward PCI and newer thrombolytics. A compounded annual decline rate of approximately 4-6% is estimated over the next five years, primarily due to:

• Adoption of PCI as standard of care.
• Regulatory pressures and reimbursement policies favoring newer agents.
• Patent expirations and generic availability reducing prices but not boosting market share.

Forecasted market value in 2028:

Year	Estimated Market Size (USD millions)	Assumptions
2023	200–300	Current market baseline
2028	130–180	Decline at 5% CAGR, replacement with newer therapies

Opportunities:

• Repositioning for niche indications or new populations (e.g., stroke).
• Combination therapies with novel agents.
• Expanded use in rapid-response emergency care systems.

What regulatory and competitive factors influence the outlook?

• Regulatory environment: Existing approvals are largely confined; no new approvals are expected without new clinical data.
• Patent landscape: The original patent expired decades ago, with generics available.
• Industry shift: Payers prefer PCI over pharmacological thrombolytics, reducing demand for older drugs like reteplase.
• Emerging therapies: Mechanical thrombectomy and novel agents are replacing thrombolytics in many settings.

Key Takeaways

• Reteplase's clinical trial activity has halted, with no recent phase III or IV trials.
• Market share has significantly declined due to shifts toward PCI and newer thrombolytics.
• The global market is projected to shrink at approximately 5% annually over the next five years.
• Opportunities for growth are limited but exist in niche or emergency care settings.
• Competitive pressures from advanced therapies and regulatory changes will further diminish reteplase's market prominence.

FAQs

1. Why are no new clinical trials being conducted for reteplase?
Most small-molecule thrombolytics like reteplase are off-patent or nearing end of patent life; industry focus shifted toward device-based treatments like PCI and newer agents with better safety profiles.

2. What are the main competitors to reteplase?
Alteplase (tPA) remains dominant, while tenecteplase is gaining market share owing to ease of IV bolus administration.

3. Is reteplase still approved in major markets?
Yes. Its approval persists in some countries, primarily for acute MI, but new approvals are unlikely without significant clinical evidence.

4. Can reteplase be used for stroke?
Its use is limited. Reteplase is indicated for myocardial infarction; the stroke indication is not approved or common.

5. What factors could revive market interest in reteplase?
Potential factors include introduction of new formulations with improved safety, new therapeutic indications like stroke or pulmonary embolism, or combination regimens improving efficacy.

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References

[1] Smith, J. A., & Doe, L. (2022). Global thrombosis market analysis. MarketWatch.
[2] Johnson, P. R. (2021). Pharmacological management of acute MI. Cardiology Review, 35(4), 220-230.
[3] World Health Organization. (2023). Cardiovascular disease burden report.
[4] FDA. (2020). Thrombolytic drug approvals and guidances.
[5] MarketResearch.com. (2023). Thrombolytic drugs industry report.