MedPath

Dacarbazine

Generic Name
Dacarbazine
Drug Type
Small Molecule
Chemical Formula
C6H10N6O
CAS Number
4342-03-4
Unique Ingredient Identifier
7GR28W0FJI

Overview

An antineoplastic agent. It has significant activity against melanomas. (from Martindale, The Extra Pharmacopoeia, 31st ed, p564). Dacarbazine with Oblimersen is in clinical trials for the treatment of malignant melanoma.

Indication

For the treatment of metastatic malignant melanoma. In addition, dacarbazine is also indicated for Hodgkin's disease as a secondary-line therapy when used in combination with other antineoplastic agents.

Associated Conditions

  • Advanced Pancreatic Neuroendocrine Tumors (pNET)
  • Advanced Soft Tissue Sarcoma
  • Hodgkin's Lymphoma
  • Metastatic Melanoma
  • Pheochromocytoma
  • Advanced Medullary thyroid cancer

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/03
Phase 2
Recruiting
2025/05/22
Phase 2
Recruiting
National Medical Research Radiological Centre of the Ministry of Health of Russia
2025/02/19
Phase 2
Recruiting
2025/02/18
Phase 4
Recruiting
2024/12/20
Phase 2
Recruiting
2024/12/19
Phase 3
Recruiting
2024/08/20
Phase 2
Recruiting
Children's Cancer Group, China
2024/04/22
Phase 2
Recruiting
2024/04/03
Phase 3
Recruiting
2024/01/11
Phase 2
ENROLLING_BY_INVITATION
Beijing Children's Hospital

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Fresenius Kabi USA, LLC
63323-127
INTRAVENOUS
10 mg in 1 mL
10/20/2022
Fresenius Kabi USA, LLC
63323-128
INTRAVENOUS
10 mg in 1 mL
10/20/2022
Teva Parenteral Medicines, Inc.
0703-5075
INTRAVENOUS
200 mg in 20 mL
2/28/2020
Hikma Pharmaceuticals USA Inc.
0143-9245
INTRAVENOUS
10 mg in 1 mL
5/29/2020

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
DAC POWDER FOR INJECTION 200 mg/vial
SIN12499P
INJECTION, POWDER, FOR SOLUTION
200 mg/vial
1/10/2004
DBL DACARBAZINE FOR INJECTION 200 mg
SIN06424P
INJECTION, POWDER, FOR SOLUTION
200 mg/vial
7/8/1991

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.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
DACARBAZINE FOR INJECTION BP
02241445
Powder For Solution - Intravenous
600 MG / VIAL
4/4/2000
DTIC DOME INJ 200MG/VIAL
miles canada inc. - pharmaceutical division
00521183
Liquid - Intravenous
200 MG / VIAL
12/31/1976
DTIC-DOME -PWS IV 200MG/VIAL
Bayer Inc
02154854
Powder For Solution - Intravenous
10 MG / ML
10/10/1996

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
DACARBAZINA MEDAC 500 mg POLVO PARA SOLUCION PARA PERFUSION
Medac Gesellschaft Für Klinische Spezialpräparate Gmbh
62333
POLVO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
DACARBAZINA MEDAC 1000 mg POLVO PARA SOLUCION PARA PERFUSION
Medac Gesellschaft Für Klinische Spezialpräparate Gmbh
62334
POLVO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized

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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