Overview
Vinblastine derivative with antineoplastic activity against cancer. Major side effects are myelosuppression and neurotoxicity. Vindesine is used extensively in chemotherapy protocols (antineoplastic combined chemotherapy protocols).
Indication
For the treatment of acute leukaemia, malignant lymphoma, Hodgkin's disease, acute erythraemia and acute panmyelosis
Associated Conditions
- Acute Lymphoblastic Leukemia (ALL)
- Blast crisis in myelogenous leukaemia
- Malignant Melanoma
Research Report
A Comprehensive Monograph on Vindesine (DB00309): From Botanical Origins to Clinical Application and Market Realities
Executive Summary
Vindesine is a second-generation, semisynthetic vinca alkaloid, a potent antineoplastic agent derived from the natural product vinblastine. As a member of the antimicrotubule class of chemotherapeutics, its primary mechanism of action involves the inhibition of tubulin polymerization, which disrupts the formation of the mitotic spindle, leading to cell cycle arrest in metaphase and subsequent apoptosis. This report provides a comprehensive examination of Vindesine, identified by DrugBank ID DB00309 and CAS Number 53643-48-4, synthesizing data from its botanical origins to its current clinical and regulatory standing.
Clinically, Vindesine established a crucial niche in the treatment of various malignancies, most notably as a salvage therapy for acute lymphoblastic leukemia (ALL) in pediatric patients who have developed resistance to the first-generation vinca alkaloid, vincristine. Its activity also extends to lymphomas, melanoma, breast cancer, and lung cancer, typically as a component of combination chemotherapy regimens. The pharmacological profile of Vindesine is distinguished by its high potency and a lack of complete cross-resistance with vincristine, underpinning its value in second-line treatment protocols. However, its therapeutic utility is balanced by significant dose-limiting toxicities, primarily myelosuppression (specifically granulocytopenia) and peripheral neurotoxicity, which require careful clinical management and dose adjustment.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/12/03 | Phase 2 | Not yet recruiting | |||
2024/04/11 | Phase 3 | Recruiting | First Affiliated Hospital of Zhejiang University | ||
2021/09/20 | Phase 2 | UNKNOWN | PETHEMA Foundation | ||
2021/05/24 | Phase 2 | Recruiting | |||
2020/01/09 | Phase 3 | Recruiting | |||
2019/08/02 | Phase 3 | Recruiting | University Hospital Muenster | ||
2018/08/22 | Phase 3 | Recruiting | Martin Schrappe | ||
2017/07/02 | Phase 3 | Active, not recruiting | University Hospital Muenster | ||
2017/01/12 | Phase 3 | UNKNOWN | |||
2016/12/08 | Phase 1 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
ELDISINE vindesine sulfate 5mg powder for injection vial | 60703 | Medicine | A | 8/14/1997 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
ELDISINE INJ 5MG/2ML | eli lilly canada inc | 00555665 | Powder For Solution - Intravenous | 5 MG / VIAL | 12/31/1982 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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