Drug · Other
Dactinomycin
CI-DRUG-00000664Explore in graph →CHEMBL1554 Approved
Regulatory
Approvals (6)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | Wilms Tumor | adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. | approved | Nov 9, 2017 | openfda |
| US FDA | Rhabdomyosarcoma | adult and pediatric patients with rhabdomyosarcoma, as part of a multiphase, combination chemotherapy regimen. | approved | Nov 9, 2017 | openfda |
| US FDA | Ewing Sarcoma | adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. | approved | Nov 9, 2017 | openfda |
| US FDA | Malignant Testicular Neoplasm | adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 15 days agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 14 | 8 | 27 | 50 | 6 | CA, US | Dec 31, 1963 | 1991-10 |
| Malignant Testicular Neoplasm | Approved | — | 0 | 0 | 0 | 0 | 1 | US | Nov 9, 2017 | — |
| Malignant Kidney Neoplasm | Phase3 | Phase 3 | 1 | 1 | 8 | 10 | 0 | — | — | 1993-07 |
| Leukemia | Phase3 | Phase 3 | 0 | 0 | 1 | 1 | 0 | — |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
Clinical trials
Trials with this intervention (50)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT02567435 | Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma | active not recruiting | Phase 3 | 325 | National Cancer Institute (NCI)NIH | 5 | Aug 28, 2026 | clinicaltrials |
| NCT05304585 | Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma | recruiting |