Cabergoline - PharmaKB

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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Clinical

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Events

FDA approval date

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Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
nervous system diseases	D009422
endocrine system diseases	D004700

Trade Name

FDA

EMA

Cabergoline (discontinued: Cabergoline, Dostinex)

Drug Products

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EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Cabergoline

Tradename	Company	Number	Date	Products
DOSTINEX	Pfizer	N-020664 DISCN	1996-12-23	1 products, RLD

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FDA

EMA

Brand Name	Status	Last Update
cabergoline	ANDA	2024-12-20

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
parkinson disease	EFO_0002508	D010300	G20
adenoma	—	D000236	—
hyperprolactinemia	—	D006966	E22.1

Agency Specific

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EMA

No data

Patent Expiration

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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

68 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 disease	D010300	EFO_0002508	G20	—	—	—	2	3	5

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Restless legs syndrome	D012148	EFO_0004270	G25.81	—	—	2	—	—	2
Psychomotor agitation	D011595	—	—	—	—	2	—	—	2
Syndrome	D013577	—	—	—	—	2	—	—	2

Indications Phases 2

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Indications Phases 1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hyperprolactinemia	D006966	—	E22.1	—	—	—	—	2	2
Heart valve diseases	D006349	EFO_0009551	I08	—	—	—	—	1	1
Parkinsonian disorders	D020734	—	G20.C	—	—	—	—	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