Overview
A compound composed of a two cyclic peptides attached to a phenoxazine that is derived from streptomyces parvullus. It binds to DNA and inhibits RNA synthesis (transcription), with chain elongation more sensitive than initiation, termination, or release. As a result of impaired mRNA production, protein synthesis also declines after dactinomycin therapy. (From AMA Drug Evaluations Annual, 1993, p2015)
Indication
For the treatment of Wilms' tumor, childhood rhabdomyosarcoma, Ewing's sarcoma and metastatic, nonseminomatous testicular cancer as part of a combination chemotherapy and/or multi-modality treatment regimen
Associated Conditions
- Ewing's Sarcoma
- Gestational Trophoblastic Neoplasia
- Osteosarcoma
- Ovarian Cancer
- Rhabdomyosarcomas
- Wilms' tumor
- Metastatic nonseminomatous Testicular cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/18 | Phase 3 | Recruiting | |||
2024/05/06 | Phase 3 | Recruiting | |||
2024/03/13 | Phase 2 | Completed | |||
2023/09/08 | Not Applicable | Recruiting | |||
2023/09/05 | Phase 2 | Recruiting | |||
2023/09/01 | Phase 2 | Recruiting | |||
2022/03/31 | Phase 3 | Recruiting | |||
2021/08/06 | Phase 3 | Active, not recruiting | |||
2020/11/12 | Phase 1 | Recruiting | |||
2020/09/24 | Not Applicable | Recruiting | xiang yang |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| XGen Pharmaceuticals DJB, Inc. | 39822-2100 | INTRAVENOUS | 0.5 mg in 1 mL | 2/23/2021 | |
| Eugia US LLC | 55150-431 | INTRAVENOUS | 0.5 mg in 1 mL | 12/20/2023 | |
| Hisun Pharmaceuticals USA, Inc. | 42658-008 | INTRAVENOUS | 0.5 mg in 1 1 | 9/17/2020 | |
| Prasco Laboratories | 66993-489 | INTRAVENOUS | 0.5 mg in 1 mL | 1/18/2024 | |
| Recordati Rare Diseases, Inc. | 55292-811 | INTRAVENOUS | 0.5 mg in 1 mL | 1/18/2024 | |
| Meitheal Pharmaceuticals Inc. | 71288-129 | INTRAVENOUS | 0.5 mg in 1 mL | 8/31/2020 | |
| AuroMedics Pharma LLC | 55150-928 | INTRAVENOUS | 0.5 mg in 1 mL | 8/11/2022 |
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 |
|---|---|---|---|---|---|
| K. U. DACTINOMYCIN FOR INJECTION 0.5 mg/vial | SIN10989P | INJECTION, POWDER, FOR SOLUTION | 0.5 mg/vial | 6/25/1999 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Dactinomycin for Injection | 国药准字H31021714 | 化学药品 | 注射剂 | 7/20/2020 | |
| Dactinomycin for Injection | 国药准字H20023504 | 化学药品 | 注射剂 | 6/23/2020 |
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 |
|---|---|---|---|---|---|
| Cosmegen dactinomycin (actinomycin D) 0.5mg injection | 10463 | Medicine | A | 7/22/1991 |
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