CLINICAL TRIALS PROFILE FOR ONCOVIN

505(b)(2) Clinical Trials for ONCOVIN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT01760226 ↗	Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies	Completed	National Cancer Institute (NCI)	Early Phase 1	2013-01-01	The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage	NCT01760226 ↗	Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies	Completed	Texas Children's Hospital	Early Phase 1	2013-01-01	The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage	NCT01760226 ↗	Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies	Completed	Baylor College of Medicine	Early Phase 1	2013-01-01	The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
OTC	NCT03742258 ↗	Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2019-03-13	The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
OTC	NCT03742258 ↗	Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma	Active, not recruiting	Northwestern University	Phase 1	2019-03-13	The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.

All Clinical Trials for ONCOVIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002590 ↗	Combination Chemotherapy in Treating Children With Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1994-07-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have lymphoma.
NCT00002590 ↗	Combination Chemotherapy in Treating Children With Lymphoma	Completed	Children's Oncology Group	Phase 2	1994-07-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have lymphoma.
NCT00002618 ↗	Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma	Completed	National Cancer Institute (NCI)	Phase 3	1994-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different doses may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with various combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma.
NCT00002618 ↗	Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma	Completed	Children's Oncology Group	Phase 3	1994-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different doses may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with various combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma.
NCT00002740 ↗	Combination Chemotherapy Plus Peripheral Stem Cell Transplantation Followed by Surgery and/or Radiation Therapy in Treating Young Patients With Advanced Neuroblastoma	Completed	National Cancer Institute (NCI)	Phase 1	1996-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation followed by surgery and/or radiation therapy in treating young patients who have newly diagnosed advanced neuroblastoma.
NCT00002740 ↗	Combination Chemotherapy Plus Peripheral Stem Cell Transplantation Followed by Surgery and/or Radiation Therapy in Treating Young Patients With Advanced Neuroblastoma	Completed	Children's Oncology Group	Phase 1	1996-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation followed by surgery and/or radiation therapy in treating young patients who have newly diagnosed advanced neuroblastoma.

Clinical Trial Conditions for ONCOVIN

Condition Name

Condition Name for ONCOVIN
Intervention	Trials
Acute Lymphoblastic Leukemia	25
Lymphoma	25
Leukemia	23
Untreated Adult Acute Lymphoblastic Leukemia	13

Condition MeSH

Condition MeSH for ONCOVIN
Intervention	Trials
Lymphoma	102
Leukemia	67
Precursor Cell Lymphoblastic Leukemia-Lymphoma	62
Leukemia, Lymphoid	60

Clinical Trial Locations for ONCOVIN

Trials by Country

Trials by Country for ONCOVIN
Location	Trials
Canada	375
New Zealand	43
Puerto Rico	40
Italy	38
Poland	9

Trials by US State

Trials by US State for ONCOVIN
Location	Trials
Texas	115
California	110
New York	108
Ohio	97
Illinois	97

Clinical Trial Progress for ONCOVIN

Clinical Trial Phase

Clinical Trial Phase for ONCOVIN
Clinical Trial Phase	Trials
PHASE2	2
PHASE1	1
Phase 3	63

Clinical Trial Status

Clinical Trial Status for ONCOVIN
Clinical Trial Phase	Trials
Completed	77
Active, not recruiting	46
Recruiting	43

Clinical Trial Sponsors for ONCOVIN

Sponsor Name

Sponsor Name for ONCOVIN
Sponsor	Trials
National Cancer Institute (NCI)	126
Children's Oncology Group	56
M.D. Anderson Cancer Center	19

Sponsor Type

Sponsor Type for ONCOVIN
Sponsor	Trials
Other	215
NIH	126
Industry	64

Clinical Trials Update, Market Analysis, and Projection for Oncovin (Vincristine)

Last updated: October 28, 2025

Introduction

Oncovin, the brand name for Vincristine, remains a cornerstone in the treatment of various malignancies, notably hematologic cancers such as leukemia, lymphoma, and solid tumors. As a microtubule inhibitor derived from the periwinkle plant Catharanthus roseus, Vincristine disrupts mitotic spindle formation, leading to cell cycle arrest. Despite its longstanding clinical use, recent developments in clinical trials and evolving market dynamics are shaping the future trajectory of Oncovin. This report synthesizes current clinical trial data, provides a comprehensive market analysis, and offers projections for the upcoming years, empowering stakeholders to navigate this vital oncology therapeutic.

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Clinical Trials Update

Recent Clinical Trials and Emerging Data

Recent clinical trials for Vincristine (Oncovin) focus primarily on its optimized use in combination therapies, novel formulations to enhance safety, and its role in emerging treatment protocols for resistant cancers.

• Combination Therapies in Hematologic Malignancies: Multiple phase II and III trials incorporate Vincristine with targeted agents such as monoclonal antibodies (e.g., rituximab) and immunomodulators for non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL). A notable trial (NCT03677243) investigates its use alongside CAR-T cell therapies, aiming to improve response rates [1].

• Neuropathy Management and Delivery Optimization: Due to dose-limiting neurotoxicity, especially peripheral neuropathy, several studies (NCT04568224) explore alternative administration routes and dose adjustments, as well as neuroprotective agents, to maintain clinical efficacy while reducing adverse events [2].

• Novel Formulations and Drug Delivery Platforms: Liposomal Vincristine formulations are under investigation to mitigate systemic toxicity. For instance, a phase I trial (NCT04812356) assesses liposomal Vincristine in pediatric leukemia to improve pharmacokinetics and reduce neurotoxicity [3].

• Resistance and Biomarker Development: Trials examining mechanisms of Vincristine resistance—particularly in relapsed/refractory cancers—seek to identify predictive biomarkers for treatment optimization (NCT04262450). These efforts aim to refine patient selection and improve outcomes.

Key Challenges and Opportunities in Clinical Development

While Vincristine's efficacy remains validated, challenges include its neurotoxicity profile and limited penetration in certain tumor microenvironments. Innovative delivery systems, such as nanoparticle carriers, and combinatorial strategies with novel agents could expand its utility.

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Market Analysis

Global Market Overview

The Vincristine market—represented by Oncovin—is characterized by its entrenched role in oncology treatment and the ongoing demand driven by cancer prevalence. As of 2022, the global oncology drug market was valued at approximately USD 180 billion, with plant-derived chemotherapeutics like Vincristine accounting for a significant segment [4].

Market Size & Growth Drivers:

• Established Clinical Utility: Vincristine has long been a first-line chemotherapeutic agent in childhood ALL, Hodgkin’s lymphoma, and non-Hodgkin lymphoma.

• Pipeline and New Indications: Expansion into solid tumors such as neuroblastoma and perturbations to standard regimes in acute myeloid leukemia (AML) contribute to growth.

• Regional Dynamics: Emerging markets in Asia-Pacific exhibit increased adoption due to expanding healthcare infrastructure. North America and Europe sustain dominant shares owing to high-quality healthcare systems and longstanding reliance.

• Patent & Regulatory Landscape: Since Vincristine is a generic agent, the absence of patent protection limits revenue from branded formulations, but new delivery systems and combination therapies offer avenues for premium pricing.

Competitive Landscape

The competitive environment is primarily composed of generic suppliers and a handful of companies developing innovative formulations.

Key Players	Product Focus	Market Position
Pfizer (marketed as Oncovin)	Vincristine sulfate injectable	Market leader; established brand
Hospira (Pfizer division)	Generic Vincristine formulations	Significant share in generics
Sun Pharma	Generic formulations	Growing presence in emerging markets
Innovator firms	Liposomal Vincristine, nanoparticle variants	R&D focus on toxicity reduction, limited commercial success so far

Market Trends and Opportunities

• Shift Toward Biosimilars and Generics: As patent exclusivity lapses, biosimilar and generic versions will dominate, intensifying price competition but also expanding access.

• Emerging Innovations: Liposomal deliveries and combinatorial regimens with immunotherapies present opportunities for premium pricing and extended indications.

• Regulatory & Reimbursement Challenges: Uniform global regulatory approval processes and reimbursement policies influence market penetration and profits.

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Market Projections

Forecast Outlook (2023–2030)

Based on current clinical developments, demographic trends, and technological innovations, the Vincristine market is poised for moderate growth with nuanced shifts.

• Compound Annual Growth Rate (CAGR): Estimated at approximately 3.2% over 2023–2030, driven by increased adoption in combination therapies and expanding indications.

• Market Value Projection: Anticipated to reach USD 2.1 billion by 2030, considering rising cancer prevalence, especially in developing regions, and pipeline advancements.

Factors Influencing Future Growth

• Increased Precision Oncology: Identifying biomarkers predicting Vincristine response will refine patient selection, possibly improving outcomes and adoption.

• Technological Innovations: Liposomal and nanoparticle formulations are projected to account for up to 15% of Vincristine sales by 2030, driven by their potential to reduce neurotoxicity.

• Regulatory Approvals & Off-Label Uses: Approval for new indications could serve as catalysts for growth. Conversely, safety concerns could temper optimism.

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Implications for Stakeholders

• Pharmaceutical Companies: Focus on formulation improvements and new combinations will sustain pipeline vitality.

• Healthcare Providers: Balancing efficacy with toxicity management remains central, emphasizing the importance of individualized therapy.

• Investors & Payers: Stable revenue streams through generics, but innovation-driven premium products could catalyze incremental value.

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Key Takeaways

• Clinical Evolution: Ongoing trials aim to optimize Vincristine’s efficacy-to-toxicity ratio through novel formulations and combination protocols, preserving its clinical relevance.

• Market Dynamics: The Vincristine market is transitioning from brand dominance to a landscape shaped by generics, biosimilars, and technological innovations targeting enhanced safety profiles.

• Growth Outlook: Moderate but steady, with projections indicating a USD 2.1 billion market size by 2030, supported by rising cancer incidences and expanded indications.

• Strategic Focus: Investment in delivery technologies and biomarker identification can foster competitive advantages and extend Vincristine’s therapeutic landscape.

• Regulatory & Economic Factors: Pricing pressures from generics, coupled with regulatory pathways for new formulations, will influence market trajectories and commercial strategies.

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FAQs

1. What are the primary clinical indications for Vincristine (Oncovin)?
Vincristine is chiefly used in the treatment of hematological malignancies such as childhood acute lymphoblastic leukemia (ALL), Hodgkin’s lymphoma, and non-Hodgkin lymphoma. It is also applied in certain solid tumors like neuroblastoma [5].

2. Are there any recent advancements in Vincristine formulations?
Yes. Liposomal formulations and nanoparticle delivery systems are under investigation to improve pharmacokinetics and reduce neurotoxicity. These innovative approaches demonstrate promising early results but are not yet widely approved.

3. What is the outlook for Vincristine resistance?
Resistance remains a challenge, particularly in relapsed cases. Ongoing research seeks to understand mechanisms of resistance—such as drug efflux pumps—and develop biomarkers for resistance prediction, enabling better patient stratification.

4. How does the patent landscape influence the Vincristine market?
Since Vincristine is off-patent, the market is flooded with generic versions, leading to price competition. No significant patented formulations currently exist, but research on new delivery technologies presents future patent opportunities.

5. What factors could impede Vincristine’s market growth?
Potential barriers include neurotoxicity concerns limiting higher dosing, the rise of targeted therapies that may replace chemotherapy in certain indications, and regulatory hurdles for new formulations or indications.

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References

[1] ClinicalTrials.gov. “Vincristine-based combination therapies in hematologic cancers.” NCT03677243.
[2] National Institutes of Health. “Neurotoxicity mitigation strategies with Vincristine.” NCT04568224.
[3] Pediatric Oncology Trials. “Liposomal Vincristine in pediatric leukemia.” NCT04812356.
[4] Grand View Research. “Global Oncology Drugs Market Size, Share & Trends Analysis.” 2022.
[5] National Cancer Institute. “Vincristine (Vincasar).”

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In conclusion, Vincristine (Oncovin) continues to be a vital, evolving component of cancer therapy. Advancements in clinical trial research and formulation innovation are poised to sustain its relevance, while market forces favor both generic proliferation and niche, high-value formulations. Stakeholders maintaining agility in adopting these innovations will be positioned for sustained success in the oncology domain.