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Dactinomycin
Cosmegen (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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Drugs Approved for Childhood Cancers
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
neoplasmsD009369
eye diseasesD005128
urogenital diseasesD000091642
hereditary congenital and neonatal diseases and abnormalitiesD009358
endocrine system diseasesD004700
Trade Name
FDA
EMA
Cosmegen (generic drugs available since 2017-11-09)
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 RX1982-01-01
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
cosmegenNew Drug Application2021-01-12
dactinomycinNDA authorized generic2023-01-19
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
choriocarcinoma—D002822C58
ewing sarcomaEFO_0000173D012512—
gestational trophoblastic disease—D031901O01.9
kaposi sarcoma—D012514C46
melanoma—D008545—
neuroblastomaEFO_0000621D009447—
retinoblastoma—D012175—
rhabdomyosarcoma—D012208—
soft tissue neoplasms—D012983—
testicular neoplasms—D013736C62
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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
47 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SarcomaD012509—88——16
RhabdomyosarcomaD012208145——9
Embryonal rhabdomyosarcomaD018233—14——5
Kidney neoplasmsD007680EFO_0003865C64—14——5
Trophoblastic neoplasmsD014328—12—14
Alveolar rhabdomyosarcomaD018232—13——4
Wilms tumorD009396—12——3
Hydatidiform moleD006828O01——2——2
Rhabdoid tumorD018335—11——2
Gestational trophoblastic diseaseD031901O01.9——1—12
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD00854513———3
Ovarian neoplasmsD010051EFO_0003893C56—2———2
Renal cell carcinomaD002292—1———1
Alveolar soft part sarcomaD018234—1———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Invasive hydatidiform moleD002820D39.2————11
Ewing sarcomaD012512EFO_0000173————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDACTINOMYCIN
INNdactinomycin
Description
Actinomycin D is an actinomycin. It has a role as a mutagen.
Classification
Protein
Drug classantibiotics (Streptomyces strain)
Image (chem structure or protein)
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
RxCUI3100
ChEMBL IDCHEMBL1554
ChEBI ID27666
PubChem CID457193
DrugBankDB00970
UNII ID1CC1JFE158 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 4,768 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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49,302 adverse events reported
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