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.

health-canada-dpdRegulatory6 approval records from 2 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as COSMEGEN (DIN 00213071) under ATC L01DA01 DACTINOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 31, 1963	health-canada-dpd
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.

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

No curated evidence item mentions this therapy yet.

Clinical trials

Trials with this intervention (50)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 50 studies · status and phase as posted by the registrant; each row links to the study record.

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

Molecule

Record

Kind: Other
Mechanism: DNA inhibitor
UNII: 1CC1JFE158
Aliases: Actinomycin c1, Actinomycin d, Actinomycin i1, Actinomycin iv, Actinomycin x1, COSMEGEN, Cosmegen lyovac, Dactinomicina, Dactinomycin, Dactinomycine, Dactinomycinum, Dilactone actinomycin d acid, GNF-Pf-1977, GNF-PF-2290, Meractinomycin, NCI-C04682, NSC-3053, Oncostatin k

Data updated 2 days agoSource updated unknown

Identifiers

Codes (3)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01DA01	DACTINOMYCIN
DIN (Health Canada)	00213071	COSMEGEN
DPD drug code	250