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AboutPricing
Drug ReportsDactinomycin
Dactinomycin
Dactinomycin (dactinomycin) is a protein pharmaceutical. Dactinomycin was first approved as Cosmegen on 1982-01-01. It is used to treat choriocarcinoma, ewing sarcoma, gestational trophoblastic disease, kaposi sarcoma, and melanoma amongst others in the USA.
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Events Timeline
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YTD
1Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
neoplasmsD009369
eye diseasesD005128
urogenital diseasesD000091642
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
Trade Name
FDA
EMA
Dactinomycin (discontinued: Cosmegen, Dactinomycin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dactinomycin
Tradename
Company
Number
Date
Products
COSMEGENRecordatiN-050682 DISCN1982-01-01
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
cosmegenNew Drug Application2024-01-18
dactinomycinANDA2024-06-18
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
neuroblastomaEFO_0000621D009447—
uterine neoplasmsEFO_0003859D014594C55
melanoma—D008545—
retinoblastoma—D012175—
gestational trophoblastic disease—D031901O01.9
soft tissue neoplasms—D012983—
testicular neoplasms—D013736C62
ewing sarcomaEFO_0000173D012512—
rhabdomyosarcoma—D012208—
kaposi sarcoma—D012514C46
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Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01D: Cytotoxic antibiotics and related substances
— L01DA: Actinomycines
— L01DA01: Dactinomycin
HCPCS
Code
Description
J9120
Injection, dactinomycin, 0.5 mg
Clinical
Clinical Trials
67 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80—461415
Wilms tumorD009396EFO_0000212——281213
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RhabdomyosarcomaD012208——2910—221
SarcomaD012509———99—321
Kidney neoplasmsD007680EFO_0003865C64—29——11
Gestational trophoblastic diseaseD031901—O01.9—35—210
Trophoblastic neoplasmsD014328———26—18
Embryonal rhabdomyosarcomaD018233———16—18
Alveolar rhabdomyosarcomaD018232———15——6
Ewing sarcomaD012512EFO_0000173———2—24
Hydatidiform moleD006828—O01——3——3
ChoriocarcinomaD002822—C58——2—13
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD008545——13———3
Germ cell and embryonal neoplasmsD009373———3———3
CarcinomaD002277—C80.0—2———2
FibrosarcomaD005354———2———2
Clear cell sarcomaD018227———2———2
Ovarian neoplasmsD010051EFO_0003893C56—2———2
Urologic neoplasmsD014571—C64-C68—1———1
Urinary bladder neoplasmsD001749—C67—1———1
Transitional cell carcinomaD002295———1———1
Alveolar soft part sarcomaD018234———1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Philadelphia chromosomeD010677——1————1
Lymphoid leukemiaD007945—C911————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Primitive neuroectodermal tumorsD018242——————22
Invasive hydatidiform moleD002820—D39.2————11
Thyroid neoplasmsD013964EFO_0003841—————11
NeuroblastomaD009447EFO_0000621—————11
DiseaseD004194EFO_0000408R69————11
Thyroid diseasesD013959HP_0000820E00-E07————11
Pituitary neoplasmsD010911——————11
Sex cord-gonadal stromal tumorsD018312EFO_1000052—————11
PinealomaD010871——————11
Sertoli-leydig cell tumorD018310——————11
Show 8 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDactinomycin
INNdactinomycin
Description
2-amino-4,6-dimethyl-3-oxo-N1,N9-bis[7,11,14-trimethyl-2,5,9,12,15-pentaoxo-3,10-di(propan-2-yl)-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]phenoxazine-1,9-dicarboxamide is a cyclodepsipeptide.
Classification
Protein
Drug classantibiotics (Streptomyces strain)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1c2oc3c(C)ccc(C(=O)N[C@@H]4C(=O)N[C@H](C(C)C)C(=O)N5CCC[C@H]5C(=O)N(C)CC(=O)N(C)[C@@H](C(C)C)C(=O)O[C@@H]4C)c3nc-2c(C(=O)N[C@@H]2C(=O)N[C@H](C(C)C)C(=O)N3CCC[C@H]3C(=O)N(C)CC(=O)N(C)[C@@H](C(C)C)C(=O)O[C@@H]2C)c(N)c1=O
Identifiers
PDB—
CAS-ID50-76-0
RxCUI—
ChEMBL IDCHEMBL1554
ChEBI ID27666
PubChem CID2019
DrugBankDB00970
UNII ID1CC1JFE158 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Dactinomycin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 36,365 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,725 adverse events reported
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