CLINICAL TRIALS PROFILE FOR RETEPLASE

All Clinical Trials for reteplase

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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. ...
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.
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.

Clinical Trial Conditions for reteplase

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for reteplase

Trials by Country

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

Trials by US State

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−

Trials by US State for reteplase
Location	Trials
District of Columbia	3
Ohio	2
North Carolina	2
Missouri	2
Maine	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
Chiesi Farmaceutici S.p.A.	2
National Institute of Neurological Disorders and Stroke (NINDS)	2
Chiesi USA	1

Sponsor Type

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

Reteplase: Clinical Trials, Market Analysis, and Projections

Introduction to Reteplase

Reteplase, a third-generation thrombolytic agent, is a non-glycosylated variant of alteplase, characterized by a longer half-life that facilitates double-bolus administration with a fixed dosage and enhanced thrombolytic effect. This drug is primarily used to treat acute myocardial infarction (AMI) but is also being explored for its efficacy in other thrombotic conditions, including ischemic stroke.

Clinical Trials: RAISE Trial

One of the most significant clinical trials involving reteplase is the RAISE (Reteplase versus Alteplase for Acute Ischaemic Stroke within 4.5 hours) trial. Here are the key points from this trial:

Trial Design

• The RAISE trial is a multicentre, prospective, randomised, open-label, blinded endpoint (PROBE), controlled phase 3 non-inferiority trial[1][3][4].
• A total of 1412 eligible patients are randomly assigned to receive either reteplase at a dose of 18 mg + 18 mg or alteplase 0.9 mg/kg at a ratio of 1:1.

Primary and Secondary Outcomes

• The primary efficacy outcome is the proportion of individuals achieving an excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0-1 at 90 days.
• Secondary efficacy outcomes include favourable functional outcome (mRS 0-2), major neurological improvement on the National Institutes of Health Stroke Scale, ordinal distribution of mRS, and Barthel Index score of at least 95 points at 90 days.
• The primary safety outcome is symptomatic intracranial hemorrhage within 36 hours after symptom onset[3][4].

Trial Results

• The trial has shown that reteplase is superior to alteplase in improving patients' functional outcomes without increasing the incidence of symptomatic intracranial hemorrhage. Specifically, 707 patients were assigned to the reteplase cohort and 705 to the alteplase cohort, with reteplase demonstrating better outcomes in terms of excellent functional outcomes at 90 days[4].

Market Analysis

The market for reteplase is growing rapidly, driven by several key factors.

Market Size and Growth

• The global reteplase market was estimated to be worth USD 329.72 million in 2022 and is projected to reach USD 1,792.12 million by 2030, growing at a CAGR of 23.56% during the forecast period[2].
• Another report estimates the market size to be USD 694.1 million in 2022, projected to reach USD 2547.5 million by 2030, with a CAGR of 18.9%[5].

Market Segmentation

• The market is segmented by type (powder and solution), with the powder form projected to witness significant market share during the forecast period[2].
• The market is also segmented by application (hospital, clinic) and socioeconomic factors (level of income, insurance coverage)[5].

Market Dynamics

• The increasing incidence of cardiovascular diseases, such as heart attacks and other circulatory conditions, is a major driver of the demand for reteplase. Factors contributing to this rise include inactivity, poor eating habits, smoking, obesity, and an ageing population[5].

Competitive Landscape

• The reteplase market is highly competitive, with several pharmaceutical companies investing heavily in research and development to improve the safety and effectiveness of the drug. This competition is expected to drive innovation and market growth[5].

Market Projections

Future Growth

• The reteplase market is poised for significant growth over the next several years, driven by the expanding use of thrombolytic agents in treating various thrombotic conditions. The market is expected to benefit from ongoing clinical studies and research that could expand its use beyond AMI to conditions like ischemic stroke and pulmonary embolism[5].

Emerging Trends

• Continued research and development are crucial for the market's growth. Regulatory support and efforts to improve market access will be essential in ensuring that reteplase is widely available and effectively used in healthcare settings[5].

Key Takeaways

• Clinical Trials: The RAISE trial has demonstrated the superiority of reteplase over alteplase in achieving excellent functional outcomes in patients with acute ischemic stroke.
• Market Growth: The global reteplase market is projected to grow significantly, with a CAGR ranging from 18.9% to 23.56% over the forecast period.
• Market Segmentation: The market is segmented by type, application, and socioeconomic factors, with the powder form expected to dominate.
• Market Drivers: Increasing incidence of cardiovascular diseases and ongoing research are key drivers of the market.

FAQs

Q: What is the primary use of reteplase?

A: Reteplase is primarily used to treat acute myocardial infarction (AMI) but is also being studied for use in other thrombotic conditions like ischemic stroke and pulmonary embolism.

Q: What is the RAISE trial?

A: The RAISE trial is a multicentre, prospective, randomised trial comparing reteplase and alteplase for acute ischemic stroke within 4.5 hours, aiming to determine if reteplase is non-inferior to alteplase in achieving excellent functional outcomes.

Q: What are the projected market sizes for reteplase by 2030?

A: The global reteplase market is projected to reach USD 1,792.12 million by 2030 according to one report, and USD 2547.5 million according to another.

Q: What drives the demand for reteplase?

A: The increasing incidence of cardiovascular diseases, such as heart attacks and other circulatory conditions, driven by factors like inactivity, poor eating habits, smoking, obesity, and an ageing population.

Q: How competitive is the reteplase market?

A: The reteplase market is highly competitive, with several pharmaceutical companies investing in research and development to improve the drug's safety and effectiveness.

Sources

1. Reteplase versus alteplase for acute ischaemic stroke within 4.5 hours (RAISE) trial: BMJ, 2024.
2. Reteplase Market by Type, Application, Distribution Channel: 360iResearch, 2023.
3. Reteplase versus alteplase for acute ischaemic stroke within 4.5 hours: PubMed, 2024.
4. Trial Favors Reteplase Over Alteplase in Improving Functional Outcomes in Ischemic Stroke: Applied Clinical Trials Online, 2024.
5. Reteplase Market Growth, And Opportunities (2023-2030): Contrivedatum Insights, 2023.