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Drug ReportsCabergoline
Cabergoline
Cabergoline (cabergoline) is a small molecule pharmaceutical. Cabergoline was first approved as Dostinex on 1996-12-23. It is used to treat adenoma, hyperprolactinemia, and parkinson disease in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
nervous system diseasesD009422
endocrine system diseasesD004700
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cabergoline
Tradename
Company
Number
Date
Products
DOSTINEXMylanN-020664 DISCN1996-12-23
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
cabergolineANDA2024-01-31
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
G: Genito urinary system and sex hormones
— G02: Other gynecologicals in atc
— G02C: Other gynecologicals in atc
— G02CB: Prolactine inhibitors
— G02CB03: Cabergoline
N: Nervous system drugs
— N04: Anti-parkinson drugs
— N04B: Dopaminergic agents
— N04BC: Dopamine agonists
— N04BC06: Cabergoline
HCPCS
Code
Description
J8515
Cabergoline, oral, 0.25 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
Parkinson diseaseD010300EFO_0002508G20——2237
ProlactinomaD015175HP_0006767——11146
Pituitary neoplasmsD010911———13126
AcromegalyD000172————1416
Pituitary acth hypersecretionD047748EFO_1001110E24.0—111—3
Fertilization in vitroD005307—————2—2
Drug-related side effects and adverse reactionsD064420—T88.7———112
Prostatic neoplasmsD011471—C61———1—1
MelanomaD008545—————1—1
Neuroendocrine tumorsD018358EFO_1001901D3A.8———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ovarian hyperstimulation syndromeD016471——114—16
InfertilityD007246HP_0000789——44——4
Restless legs syndromeD012148EFO_0004270G25.81——2——2
Acth-secreting pituitary adenomaD049913————1——1
AdenomaD000236————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Substance-related disordersD019966EFO_0003890F1311——13
Polycystic ovary syndromeD011085EFO_0000660E28.2—1——12
EndometriosisD004715EFO_0001065N80—2———2
Cocaine-related disordersD019970—F1411———2
Body weightD001835EFO_0004338—11———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD013810——2————2
Breast neoplasmsD001943EFO_0003869C501————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperprolactinemiaD006966HP_0000870E22.1————33
Disease resistanceD060467——————11
Parkinsonian disordersD020734HP_0001300G20.C————11
Insulin resistanceD007333HP_0000855E88.819————11
Postpartum depressionD019052EFO_0007453F53.0————11
RecurrenceD012008——————11
Type 2 diabetes mellitusD003924EFO_0001360E11————11
Conduct disorderD019955EFO_0004216F91————11
Migraine disordersD008881EFO_0003821G43————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCabergoline
INNcabergoline
Description
Cabergoline is an N-acylurea that is (8R)-ergoline-8-carboxamide in which the hydrogen attached to the piperidine nitrogen (position 6) is substituted by an allyl group and the hydrogens attached to the carboxamide nitrogen are substituted by a 3-(dimethylamino)propyl group and an N-ethylcarbamoyl group. A dopamine D2 receptor agonist, cabergoline is used in the management of Parkinson's disease and of disorders associated with hyperprolactinaemia. It has a role as a dopamine agonist, an antiparkinson drug and an antineoplastic agent.
Classification
Small molecule
Drug classergot alkaloid deriviatives
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Structure (InChI/SMILES or Protein Sequence)
C=CCN1C[C@H](C(=O)N(CCCN(C)C)C(=O)NCC)C[C@@H]2c3cccc4[nH]cc(c34)C[C@H]21
Identifiers
PDB—
CAS-ID81409-90-7
RxCUI—
ChEMBL IDCHEMBL1201087
ChEBI ID3286
PubChem CID54746
DrugBankDB00248
UNII IDLL60K9J05T (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Cabergoline
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,911 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,965 adverse events reported
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