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 |
|---|---|
| neoplasms | D009369 |
| nervous system diseases | D009422 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Cabergoline (discontinued: Cabergoline, Dostinex)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cabergoline | NDA authorized generic | 2025-09-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| parkinson disease | EFO_0002508 | D010300 | G20 |
| adenoma | — | D000236 | — |
| hyperprolactinemia | — | D006966 | E22.1 |
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
76 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pituitary neoplasms | D010911 | — | — | — | 2 | 4 | 3 | 2 | 10 |
| Prolactinoma | D015175 | — | — | — | 1 | 1 | 2 | 4 | 7 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | — | 2 | 2 | 3 | 7 |
| Hyperprolactinemia | D006966 | — | E22.1 | 2 | — | 1 | 1 | 3 | 7 |
| Infertility | D007246 | EFO_0000545 | — | — | 5 | 4 | 1 | — | 6 |
| Pituitary diseases | D010900 | — | E23.7 | — | 1 | 3 | 1 | 2 | 6 |
| Acromegaly | D000172 | — | — | — | — | 1 | 4 | 1 | 6 |
| Pituitary acth hypersecretion | D047748 | EFO_1001110 | E24.0 | — | 1 | 1 | 1 | — | 3 |
| Fertilization in vitro | D005307 | — | — | — | — | — | 2 | — | 2 |
| Acth-secreting pituitary adenoma | D049913 | — | — | — | — | 1 | 1 | — | 2 |
Show 7 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ovarian hyperstimulation syndrome | D016471 | — | — | 2 | 4 | 4 | — | 2 | 11 |
| Adenoma | D000236 | — | — | — | 1 | 4 | — | 2 | 6 |
| Syndrome | D013577 | — | — | — | — | 3 | — | 1 | 4 |
| Restless legs syndrome | D012148 | EFO_0004270 | G25.81 | — | — | 2 | — | — | 2 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 1 | — | — | 1 |
| Psychomotor agitation | D011595 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | 2 | — | — | 2 | 4 |
| Endometriosis | D004715 | EFO_0001065 | N80 | — | 3 | — | — | — | 3 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | 1 | — | — | 1 | 3 |
| Cocaine-related disorders | D019970 | — | F14 | 1 | 1 | — | — | — | 2 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | 1 | — | — | 1 | 2 |
| Adrenocortical hyperfunction | D000308 | EFO_1000797 | — | — | 1 | — | — | — | 1 |
| Body weight | D001835 | EFO_0004338 | — | 1 | 1 | — | — | — | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | 1 | 1 | — | — | — | 1 |
| Chronic pain | D059350 | — | — | — | 1 | — | — | — | 1 |
| Hyperemia | D006940 | EFO_0003822 | H34.82 | — | 1 | — | — | — | 1 |
Show 3 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease | D004194 | EFO_0000408 | R69 | 2 | — | — | — | — | 2 |
| Therapeutic equivalency | D013810 | — | — | 2 | — | — | — | — | 2 |
| Health education | D006266 | — | — | 1 | — | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease resistance | D060467 | — | — | — | — | — | — | 1 | 1 |
| Heart valve diseases | D006349 | EFO_0009551 | I08 | — | — | — | — | 1 | 1 |
| Parkinsonian disorders | D020734 | — | G20.C | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | — | — | 1 | 1 |
| Postpartum depression | D019052 | EFO_0007453 | F53.0 | — | — | — | — | 1 | 1 |
| Recurrence | D012008 | — | — | — | — | — | — | 1 | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 1 | 1 |
| Conduct disorder | D019955 | EFO_0004216 | F91 | — | — | — | — | 1 | 1 |
| Adolescent development | D041923 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cabergoline |
| INN | cabergoline |
| 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 class | ergot alkaloid deriviatives |
| Image (chem structure or protein) |  |
| 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-ID | 81409-90-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201087 |
| ChEBI ID | 3286 |
| PubChem CID | 54746 |
| DrugBank | DB00248 |
| UNII ID | LL60K9J05T (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Estimated US medical usage
Cabergoline
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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4,773 adverse events reported
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