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.

Background

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
Not yet 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
Dacarbazine for Injection
国药准字H32026231
化学药品
注射剂
7/22/2020
Dacarbazine for Injection
国药准字H20043619
化学药品
注射剂
8/25/2020
Dacarbazine for Injection
国药准字H20063418
化学药品
注射剂
4/28/2021
Dacarbazine for Injection
国药准字H20063417
化学药品
注射剂
2/24/2021
Dacarbazine for Injection
国药准字H20043620
化学药品
注射剂
8/25/2020
Dacarbazine for Injection
国药准字H20063177
化学药品
冻干粉针剂
5/12/2020
Dacarbazine for Injection
国药准字H20063419
化学药品
注射剂
4/28/2021
Dacarbazine for Injection
国药准字H20057359
化学药品
注射剂
9/10/2020
Dacarbazine for Injection
国药准字H20058572
化学药品
注射剂
7/22/2020
Dacarbazine for Injection
国药准字H20057360
化学药品
注射剂
7/27/2022

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.
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