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. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
DBL DACARBAZINE 200mg Powder for Injection | 39954 | Medicine | A | 7/20/1992 | |
Hospira Dacarbazine for Injection BP, 200 mg vial | 125599 | Medicine | A | 2/15/2006 | |
Hospira Dacarbazine for Injection 600 mg/ vial | 126046 | Medicine | A | 3/10/2006 | |
Hospira Dacarbazine for Injection USP, 200 mg vial | 142149 | Medicine | A | 7/16/2007 |
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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