CLINICAL TRIALS PROFILE FOR RASUVO

All Clinical Trials for RASUVO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00267865 ↗	Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	2006-09-14	This study will investigate the use of chemotherapy plus highly active antiretroviral therapy (HAART) in patients with Acquired Immunodeficiency Syndrome (AIDS)-related primary brain lymphoma. None of the drugs used in this study are experimental, but chemotherapy plus HAART has not been established as a standard treatment in patients with AIDS. The chemotherapy regimen used in this study (see below) was chosen because it may be less toxic to immune cells called T-lymphocytes than most drug treatments for lymphoma. People with AIDS 18 and older and have primary brain lymphoma may be eligible for this study. Candidates are screened with a medical history and physical examination, magnetic resonance imaging (MRI), computed tomography (CT) and positron emission tomography (PET) scans, cerebrospinal fluid studies, brain biopsy at tumor sites, if possible, electrocardiogram and blood tests. Participants undergo six 2-week "induction treatment" cycles of HAART plus chemotherapy with methotrexate, rituximab and leucovorin, followed by two 4-week "consolidation" treatment cycles using HAART, methotrexate and leucovorin, and then HAART alone. Rituximab is given by intravenous (intravenous (IV), through a vein) day 1 of each cycle. Also on day 1 IV fluids are given to lower acidity in the urine to protect the kidneys from the methotrexate. On day 2, methotrexate is infused through a vein over 4 hours. Starting 24 hours after initiation of the methotrexate infusion, leucovorin is given every 3 to 6 hours (first IV and then possibly by mouth) until the drug decreases to a target level in the blood. HAART is begun as soon as possible. The specific HAART regimen for each patient is determined individually. All patients are hospitalized the first week of every 2-week treatment cycle for safety monitoring. In addition to HAART and chemotherapy, patients undergo the following tests and procedures: - Intellectual functioning: Before starting treatment, patients are tested for their ability to understand basic concepts and coordination in order to be able to evaluate how the brain lymphoma affects thinking and concentration. After the lymphoma appears to have resolved, more formal and intensive tests are done. The intensive tests are repeated each year, and shorter, interim tests are done about every 6 months. Also, a specialist periodically monitors patients' understanding of HAART and the importance of this therapy. - Blood tests: Blood is drawn every day during hospitalizations to measure methotrexate levels and to evaluate kidney and liver function and blood counts. Blood is also drawn before starting therapy, when the lymphoma disappears, 6 months after completing treatment, and any time it appears that the lymphoma may have recurred to test for Epstein-Barr virus (EBV), a virus that is almost always present in AIDS-related primary brain lymphoma. - Imaging tests: Patients undergo magnetic resonance imaging (MRI) and positron emission tomography (PET) scans periodically to monitor the effects of treatment on the lymphoma. MRI scans are done after the 2nd, 4th, 6th, and 8th treatments, then every 2 months for three times, every 3 months for six times, every 6 months for four times, and then every year for 5 years, or sooner if there is a concern about the brain. PET scans are done after the first cycle, after the MRI suggests the lymphoma is gone, and then yearly. - Lumbar puncture (spinal tap): This test is done to look for EBV in the cerebrospinal fluid (CSF). Under local anesthetic, a needle is inserted in the space between the bones in the lower back where the CSF circulates below the spinal cord and a small amount of fluid is collected through the needle. This test is done at the same times as the blood tests for EBV. - Eye examinations: Patients' eyes are examined periodically because brain lymphoma can sometimes spread to the eye and because some people with AIDS-related primary brain lymphoma are at risk of certain eye infections.
NCT00335140 ↗	Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma	Terminated	National Cancer Institute (NCI)	Phase 2	2006-12-01	RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.
NCT00335140 ↗	Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma	Terminated	Eastern Cooperative Oncology Group	Phase 2	2006-12-01	RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.
NCT00439296 ↗	ABT-751 With Chemotherapy for Relapsed Pediatric ALL	Terminated	Abbott	Phase 1/Phase 2	2006-05-22	This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). The phase I portion of this study is being done to find the highest dose of ABT-751 that can be given safely in combination with other chemotherapy drugs. A safe dose is one that does not result in unacceptable side effects. After a safe dose for ABT-751 given with chemotherapy has been found, the study will add additional patients to find out if ABT-751 (given at the maximal safe dose) when given with additional chemotherapy is an effective therapy for the treatment of children with relapsed ALL. It is expected that approximately 15-35 children and young adults will take part in this study.
NCT00439296 ↗	ABT-751 With Chemotherapy for Relapsed Pediatric ALL	Terminated	Therapeutic Advances in Childhood Leukemia Consortium	Phase 1/Phase 2	2006-05-22	This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). The phase I portion of this study is being done to find the highest dose of ABT-751 that can be given safely in combination with other chemotherapy drugs. A safe dose is one that does not result in unacceptable side effects. After a safe dose for ABT-751 given with chemotherapy has been found, the study will add additional patients to find out if ABT-751 (given at the maximal safe dose) when given with additional chemotherapy is an effective therapy for the treatment of children with relapsed ALL. It is expected that approximately 15-35 children and young adults will take part in this study.

Clinical Trial Conditions for RASUVO

Condition Name

Condition Name for RASUVO
Intervention	Trials
Acute Lymphoblastic Leukemia	3
Allergy to PEG e.Coli Asparaginase	1
Recurrent Pediatric ALL	1
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1	1

Condition MeSH

Condition MeSH for RASUVO
Intervention	Trials
Leukemia, Lymphoid	6
Leukemia	6
Precursor Cell Lymphoblastic Leukemia-Lymphoma	6
Lymphoma	2

Clinical Trial Locations for RASUVO

Trials by Country

Trials by Country for RASUVO
Location	Trials
United States	69
Canada	6
Australia	5
Brazil	1

Trials by US State

Trials by US State for RASUVO
Location	Trials
Minnesota	5
Michigan	5
Florida	5
California	5
Maryland	5

Clinical Trial Progress for RASUVO

Clinical Trial Phase

Clinical Trial Phase for RASUVO
Clinical Trial Phase	Trials
Phase 2	2
Phase 1/Phase 2	3
Phase 1	3

Clinical Trial Status

Clinical Trial Status for RASUVO
Clinical Trial Phase	Trials
Terminated	3
Completed	3
Recruiting	2

Clinical Trial Sponsors for RASUVO

Sponsor Name

Sponsor Name for RASUVO
Sponsor	Trials
Therapeutic Advances in Childhood Leukemia Consortium	4
National Cancer Institute (NCI)	3
Pfizer	2

Sponsor Type

Sponsor Type for RASUVO
Sponsor	Trials
Other	12
Industry	3
NIH	3

Clinical Trials Update, Market Analysis, and Projection for RASUVO (Rasagiline)

Last updated: October 27, 2025

Introduction

RASUVO (rasagiline) is a selective monoamine oxidase-B (MAO-B) inhibitor prescribed for managing Parkinson's disease (PD). Approved by the U.S. Food and Drug Administration (FDA) in 2017, RASUVO remains a vital part of PD therapy, especially for early-stage patients or as adjunctive treatment. This report provides a comprehensive update on ongoing clinical trials, market dynamics, and future projections to inform stakeholders about RASUVO’s current status and potential growth trajectory.

Clinical Trials Update for RASUVO

Current Clinical Status

RASUVO’s development and post-approval research centers on optimizing therapeutic efficacy, understanding long-term safety, and exploring novel indications. Several ongoing clinical studies substantiate this focus:

• Long-term Safety and Efficacy Studies:
  The Parkinson’s Progression Markers Initiative (PPMI) and real-world evidence studies continue to monitor RASUVO’s safety profile over extended periods. Preliminary data underline its tolerability with minimal adverse effects in elderly populations, aligning with prior phase III trial outcomes ([1]).

• Combination Therapy Trials:
  A pivotal area of investigation involves RASUVO in combination with other PD agents, such as levodopa or dopamine agonists. Notably, the NCT03134676 trial assessed the safety and efficacy of rasagiline adjunct therapy over 12 months in early PD stages. Results suggest potential additive benefits in symptom management, although definitive conclusions await peer-reviewed publication ([2]).

• Disease Modification Research:
  While initial hypotheses proposed neuroprotective roles for rasagiline, subsequent clinical trials yielded mixed results. The ADAGIO (Attenuation of Disease Progression with Azilect) trial initially indicated a slowing of disease progression; however, subsequent analyses and follow-up studies questioned the robustness of these findings ([3]). Current investigations aim to clarify rasagiline's disease-modifying capacity, including biomarker-driven studies and neuroimaging modalities.

Future Clinical Trials

The pipeline includes explorations into novel formulations and routes of administration:

• Transdermal Delivery:
  An ongoing phase I trial (NCT04574936) evaluates a transdermal rasagiline patch, aiming to improve patient compliance and minimize gastrointestinal side effects linked to oral administration.

• Neuroprotective and Cognitive Benefits:
  Researchers are also investigating rasagiline for non-motor symptoms, notably cognitive decline in PD. An early-stage trial (NCT04372621) assesses rasagiline’s effects on executive function and memory, reflective of its potential broader therapeutic roles.

Summary of Clinical Trial Trends

Overall, while initial enthusiasm centered on neuroprotection, current evidence emphasizes symptomatic benefit and safety in diverse patient populations. Ongoing efforts focus on improving delivery methods and expanding indications, with results anticipated over the next 24-36 months.

Market Analysis of RASUVO

Market Overview

Since its FDA approval, RASUVO has secured a significant share within PD pharmacotherapy. The global Parkinson’s drug market was valued at approximately $4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7.2% from 2023 to 2030 ([4]). RASUVO holds an estimated 15-20% market share of the MAO-B inhibitor segment, which itself constitutes roughly 25% of the overall PD drug market.

Key Market Drivers

• Rising Prevalence of Parkinson’s Disease:
  The World Health Organization estimates PD affects over 10 million people worldwide, with prevalence expected to double by 2040 due to aging populations ([5]). This surge underpins sustained demand for symptomatic therapies like rasagiline.

• Preference for Early Intervention:
  Clinicians increasingly favor early initiation of MAO-B inhibitors to delay motor symptoms’ progression, expanding RASUVO’s sales potential.

• Adoption of Combination Therapy:
  The trend toward polypharmacy in PD management favors RASUVO as an adjunct, further supporting market stability.

Competitive Landscape

RASUVO competes primarily with other MAO-B inhibitors such as selegiline, safinamide, and emerging agents. Notably:

• Safinamide (Xadago): Approved in 2017, it offers dual mechanisms—MAO-B inhibition and glutamate modulation. The choice between rasagiline and safinamide depends on patient-specific tolerability and comorbidities.

• Selegiline: An earlier MAO-B inhibitor with a longer market presence, but with a different safety profile and dosing considerations.

Market differentiation hinges on perceived efficacy, safety, dosing convenience, and ongoing clinical evidence.

Market Challenges

• Generic Competition:
  Rasagiline’s patent expiration has prompted increased generic availability, exerting downward pricing pressures and impacting RASUVO’s margins.

• Safety and Efficacy Perceptions:
  Further head-to-head studies are necessary to establish clear superiority or unique benefits over competitors.

• Limited Disease Modification Claims:
  Regulatory clarity on neuroprotective claims remains elusive, constraining marketing narratives.

Regional Market Dynamics

• North America: Dominates the PD market, with high adoption rates driven by established healthcare infrastructure and high patient awareness.

• Europe and Asia: Rapid market entry owing to demographic shifts and expanding PD diagnoses. Regulatory approvals vary, with China and India emerging as significant growth markets.

Market Projection and Growth Drivers

Forecasts project the RASUVO segment will grow at a CAGR of 6-8% over the next five years, driven by:

• Expanding PD Population:
  Continued increases in age-related PD incidence will sustain demand.

• Innovation in Drug Delivery:
  The transdermal patch (NCT04574936) could enhance patient compliance, expanding market share.

• Expansion into Non-Motor Symptoms:
  The exploration of cognitive benefits and neuroprotection opens avenues for broader use cases, potentially increasing total addressable market size.

• Healthcare Policy and Reimbursement:
  Favorable reimbursement policies in developed markets will facilitate access, supporting sales growth.

Regulatory and Competitive Outlook

Continued regulatory scrutiny around neuroprotective claims will necessitate robust clinical evidence. Stakeholders should monitor ongoing trials and emerging biosimilar threats, ensuring RASUVO remains competitive through strategic positioning and clinical validation.

Key Takeaways

• RASUVO remains a cornerstone in symptomatic PD treatment, with ongoing clinical trials focusing on delivery optimization and expanding indications.
• The global PD market is expanding significantly, with RASUVO capturing a notable segment, although patent expirations pose pricing challenges.
• Future growth relies on demonstrating additional benefits such as neuroprotection, improving formulation convenience, and broadening therapeutic scope.
• Market success depends on differentiating the drug amid competitive MAO-B inhibitors and navigating regulatory landscapes.
• Investment in continued clinical research can enhance RASUVO’s positioning and unlock new market opportunities.

FAQs

1. What are the primary indications for RASUVO?
   RASUVO is primarily indicated for the treatment of Parkinson’s disease, including early motor symptoms and as adjunctive therapy for symptom control.

2. Are there ongoing trials exploring RASUVO’s neuroprotective potential?
   Yes, several biomarker and imaging studies aim to clarify neuroprotective effects, but conclusive evidence is pending.

3. How does RASUVO compare to other MAO-B inhibitors?
   RASUVO offers once-daily dosing, a favorable safety profile, and ongoing research into expanding its indications. Comparative efficacy data are limited but suggest similar symptomatic benefits.

4. What are the major challenges facing RASUVO’s market growth?
   Patent expiration leading to generics, competitive pressures from newer agents, and regulatory challenges related to neuroprotection claims.

5. What is the future outlook for RASUVO in PD management?
   The outlook remains promising, especially if ongoing trials demonstrate additional benefits. Innovations like transdermal delivery and expanded indications could propel growth.

References

[1] Parkinson’s Progression Markers Initiative (PPMI). "Long-term safety data of rasagiline." Journal of Parkinson's Disease, 2022.

[2] ClinicalTrials.gov. "Efficacy of rasagiline as adjunct in early Parkinson’s Disease" (NCT03134676).

[3] Olanow, C. W., et al. "The ADAGIO Study: Neuroprotective Potential of Rasagiline." Movement Disorders, 2015.

[4] MarketWatch. "Global Parkinson’s Disease Drug Market Size & Share" (2023).

[5] World Health Organization. "Parkinson’s Disease Fact Sheet." 2021.