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Vindesine

Generic Name
Vindesine
Drug Type
Small Molecule
Chemical Formula
C43H55N5O7
CAS Number
53643-48-4
Unique Ingredient Identifier
RSA8KO39WH

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

Published: Aug 22, 2025

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.

Continue reading the full research report

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
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
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
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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