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. |
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 |