CLINICAL TRIALS PROFILE FOR VINCRISTINE SULFATE

505(b)(2) Clinical Trials for vincristine sulfate

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
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 vincristine sulfate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000658 ↗	A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma	Completed	Schering-Plough	Phase 3	1969-12-31	To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
NCT00000658 ↗	A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
NCT00000681 ↗	A Phase I Study of the Combination of Recombinant GM-CSF, AZT, and Chemotherapy (ABV) (Adriamycin, Bleomycin, Vincristine) in AIDS and Kaposi's Sarcoma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine the safety as well as the most effective dose of sargramostim (GM-CSF; granulocyte-macrophage colony stimulating factor) that will prevent the side effects caused by the combined use of zidovudine (AZT) and various doses of cancer-fighting drugs (doxorubicin, bleomycin, and vincristine) in AIDS patients with Kaposi's sarcoma (KS). Patients included in this study have KS, which is a type of cancer that occurs in nearly 20 percent of patients with AIDS. AIDS patients with extensive KS require treatment with effective cytotoxic (anti-cancer) agents to reduce the tumor size and with antiretroviral agents such as AZT to prevent or ameliorate the development of opportunistic infections. Due to the significant toxic effect of both cytotoxic and antiviral agents on the bone marrow where new blood cells are generated, the combination of these agents is expected to result in complications such as granulocytopenia (very low granulocyte counts). Hematopoietic growth factors such as GM-CSF may reduce the severity and duration of marrow suppression. This may improve survival. Clinical trials of GM-CSF in HIV infected individuals with or without granulocytopenia have shown that the progenitor cells (early blood cells) are responsive to GM-CSF.
NCT00000689 ↗	Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in AIDS-Associated Large Cell, Immunoblastic, and Small Non-cleaved Lymphoma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine the toxicity and effectiveness of adding sargramostim (recombinant granulocyte-macrophage colony stimulating factor; GM-CSF) to a standard chemotherapy drug combination (methotrexate, bleomycin, doxorubicin, cyclophosphamide, vincristine, and dexamethasone) known as mBACOD in the treatment of non-Hodgkin's lymphoma in patients who are infected with HIV. Treatment of patients with AIDS-associated lymphoma is achieving inferior results when compared with outcomes for non-AIDS patients. Treatment with mBACOD has been promising, but the toxicity is very high. Patients treated with mBACOD have very low white blood cell counts. GM-CSF has increased the number of white blood cells in animal studies and preliminary human studies. It is hoped that including GM-CSF among the drugs given to lymphoma patients will prevent or lessen the decrease in white blood cells caused by mBACOD.
NCT00000703 ↗	Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To determine the safety and effectiveness of a combination chemotherapy-radiation-zidovudine (AZT) treatment for patients with peripheral lymphoma. Other chemotherapies have been tried in patients with AIDS related lymphomas, but the results have not been satisfactory. This study will show whether the combination of chemotherapy, radiation, and AZT is more effective and less toxic than previously used treatments.
NCT00000801 ↗	Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To estimate the response rate, overall and disease-free survival, toxicities, factors associated with outcome, and effect on quality of life in patients with AIDS-related primary CNS lymphoma treated with CHOD (cyclophosphamide, doxorubicin, vincristine, and dexamethasone) plus filgrastim (granulocyte-colony stimulating factor; G-CSF) and external beam irradiation. To determine other clinical markers present in this patient population. Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma.

Clinical Trial Conditions for vincristine sulfate

Condition Name

Condition Name for vincristine sulfate
Intervention	Trials
Lymphoma	139
Leukemia	72
Neuroblastoma	33
Acute Lymphoblastic Leukemia	27

Condition MeSH

Condition MeSH for vincristine sulfate
Intervention	Trials
Lymphoma	217
Leukemia	137
Precursor Cell Lymphoblastic Leukemia-Lymphoma	124
Leukemia, Lymphoid	124

Clinical Trial Locations for vincristine sulfate

Trials by Country

Trials by Country for vincristine sulfate
Location	Trials
Canada	599
Switzerland	62
Puerto Rico	61
New Zealand	60
Norway	9

Trials by US State

Trials by US State for vincristine sulfate
Location	Trials
California	206
New York	200
Texas	177
Illinois	176
Ohio	173

Clinical Trial Progress for vincristine sulfate

Clinical Trial Phase

Clinical Trial Phase for vincristine sulfate
Clinical Trial Phase	Trials
PHASE2	4
Phase 4	1
Phase 3	162

Clinical Trial Status

Clinical Trial Status for vincristine sulfate
Clinical Trial Phase	Trials
Completed	258
Active, not recruiting	68
Unknown status	66

Clinical Trial Sponsors for vincristine sulfate

Sponsor Name

Sponsor Name for vincristine sulfate
Sponsor	Trials
National Cancer Institute (NCI)	287
Children's Oncology Group	97
Children's Cancer and Leukaemia Group	24

Sponsor Type

Sponsor Type for vincristine sulfate
Sponsor	Trials
Other	559
NIH	298
Industry	83

Last updated: April 27, 2026

Clinical Trials Update, Market Analysis and Projection for Vincristine Sulfate

Vincristine sulfate is an established, off-patent oncology product used to treat multiple cancers. Commercial dynamics are dominated by generic penetration, hospital/wholesaler sourcing, tender-driven pricing, and supply-chain reliability rather than new clinical differentiation. Clinical trial activity is limited to incremental studies (new regimens, dosing schedules, route/formulation evaluation, and use in specific molecular contexts), with no broadly transformative late-stage development signal in the global pipeline.

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What is the current clinical development footprint for vincristine sulfate?

Trial landscape: what is typically being studied

Across the literature and trial registries, vincristine sulfate development activity concentrates on three buckets:

1. Regimen integration
   Vincristine is studied as part of combination chemotherapy protocols (for example, lymphomas and acute leukemias), where the trial value comes from clinical endpoints tied to the broader regimen rather than vincristine’s standalone pharmacology.

2. Schedule and dosing optimization
   Trials evaluate dosing schedules, cycle intensity, supportive care alignment (including neuropathy management), and pediatric-adult harmonization where vincristine toxicity constraints drive regimen feasibility.

3. Formulation and administration practice
   Some studies focus on practical administration variables such as infusion practices, dosing standardization, or substitution across salts/sources, reflecting safety-critical handling and administration requirements rather than new molecular entities.

Practical read-through for investors and R&D planners

• Late-stage, registrational-grade development for vincristine sulfate is typically not the dominant pattern in recent years because the active substance is mature and commercially commoditized.
• The most material clinical value-add usually comes from label expansion through combination-protocol evidence, safety management improvements, or real-world outcomes rather than a new mechanism or new target.

Bottom line: the current “clinical trials update” for vincristine sulfate is mostly incremental and protocol-driven rather than pipeline-breaking.

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What does the market look like: buyers, pricing drivers, and competitive structure?

Commercial structure

Vincristine sulfate is sold into oncology supply chains where purchasing decisions are driven by:

• Hospital formularies and tenders
• Availability and supply continuity (tender compliance depends on uninterrupted manufacturing)
• Unit price and contract terms for generics and authorized distributors
• Handling and safety documentation (critical for cytotoxic agents)

Competitive landscape

Vincristine sulfate is largely a generic-led market in most geographies. Competitive intensity tends to show up as:

• Multiple manufacturers across wholesalers and direct hospital contracts
• Margin compression as procurement consolidates
• Substitution by therapeutically equivalent products within purchasing frameworks

Key market demand pools (clinical use impact)

Demand is anchored in established oncology indications where vincristine is standard-of-care or part of common curative/induction regimens, including:

• Lymphoid malignancies (examples include lymphomas in multi-agent protocols)
• Acute leukemias (as part of induction/consolidation regimens in pediatric-adult treatment frameworks)
• Other solid tumor protocols where vincristine has historical use in defined combinations

Because vincristine is used as a component of combination therapy, total addressable demand is tied to:

• cancer incidence and treatment intensity
• pediatric and adult oncology regimen penetration
• guideline adherence and formulary selection cycles

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How big is the opportunity: market size, growth drivers, and constraints?

Near-term growth drivers

Vincristine sulfate market growth generally comes from non-molecular drivers:

• Volume stability from ongoing incidence in relevant cancers
• Steady procurement replacement cycles in hospital systems
• Regional tender activity that reshuffles supplier share among generics

Growth constraints

• Price erosion from generic competition and tender benchmarking
• Manufacturing supply risks for cytotoxic injectables
• Cost pressure from oncology budgets and payer reimbursement dynamics
• Toxicity management capacity (neuropathy considerations can influence regimen delivery, supportive care usage, and dose modifications)

Demand outlook implication

For projection purposes, vincristine sulfate behaves more like a:

• mature essential oncology commodity than a:
• high-growth differentiated product

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What is the market projection for vincristine sulfate over the next 5 years?

Projection framework (what moves the curve)

Because vincristine sulfate is mature and generic-dominated, the primary projection mechanics are:

• Unit consumption growth (tied to cancer care delivery and population)
• ASP decline (driven by competition and tender price resets)
• Supply continuity (events that cause temporary shortages can create short-lived pricing spikes, but usually revert)

Base-case projection (directional)

• Volume: low-to-mid single digit annual growth is consistent with global oncology care expansion and stable regimen use.
• Value (revenue): likely flattish-to-low growth because ASP erosion typically offsets volume growth in commoditized injectables.
• Market share: rotates among suppliers with reliable supply and contract wins; long-term structural growth accrues less to new entrants and more to operationally stable manufacturers.

Actionable projection statement: vincristine sulfate revenue growth over 5 years is expected to be constrained by persistent generic price competition, with only limited upside from any combination-regimen expansions or supply-driven price dislocations.

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Where can value be created: strategy for manufacturers and developers?

If you manufacture vincristine sulfate (generic or authorized)

Value creation usually comes from operational and commercial execution:

• Supply reliability: uninterrupted fulfillment during tender cycles
• Contracting: winning hospital systems via logistics and documentation completeness
• Cost control: scale economics and process yield
• Quality consistency: batch-to-batch performance reduces return rates and formulary churn

If you are pursuing clinical differentiation

Differentiation must be pathway-driven because molecule-level novelty is absent. Targets that can create label or payer traction include:

• Protocol-linked evidence: outcomes with supportive care or dose modifications
• Toxicity mitigation: neuropathy management strategies that improve deliverability
• Subpopulation optimization: pediatric protocols, regimen intensification feasibility, or specific disease stages

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Investment and R&D risk map: what to watch

1. Regulatory and quality events
   Cytotoxic injectables can face rapid market share losses after quality issues.

2. Supply-chain bottlenecks
   Procurement depends on continuity; constraints can temporarily shift buying patterns.

3. Tender cycles and ASP resets
   Revenue projections should assume ongoing pricing pressure.

4. Clinical guideline stability
   If vincristine loses protocol position in specific disease areas, volume can dip even if incidence stays stable.

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Key Takeaways

• Vincristine sulfate is a mature, generic-dominated oncology product where clinical trial activity is mainly incremental and regimen-based.
• Market dynamics are tender- and supply-driven; pricing is pressured by competition rather than supported by differentiation.
• Over a 5-year horizon, expect modest volume growth but limited revenue growth due to ASP erosion.
• The most credible value creation routes are operational reliability, cost and quality excellence, and protocol-linked clinical evidence that supports deliverability and regimen adoption.

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FAQs

1) Is vincristine sulfate still in active clinical trials?

Yes, but trial work is typically protocol and regimen focused rather than centered on new mechanisms, reflecting the mature status of the active substance.

2) Will new patents materially change the vincristine market?

Vincristine sulfate is widely treated as off-patent; competitive pricing is therefore mainly determined by generic competition and procurement mechanisms rather than patent-driven exclusivity.

3) What is the biggest swing factor for vincristine sulfate revenues?

ASP declines tied to tenders and generic competition usually dominate; supply disruptions can create short-term swings but tend to normalize.

4) Which buyers drive demand most?

Hospitals and purchasing networks that buy oncology injectables via contracts and tenders.

5) Where should R&D teams focus if they want differentiation?

Focus on protocol evidence, toxicity mitigation approaches, and regimen deliverability rather than expecting molecule-level novelty to drive market change.

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References

[1] U.S. Food and Drug Administration. Drug Trials Snapshots: Vincristine Sulfate (product and label references).
[2] ClinicalTrials.gov. Vincristine sulfate search results and trial records (accessed 2026-04-28).
[3] World Health Organization. WHO Model Lists of Essential Medicines (vincristine context).