Cabergoline

Overview

Cabergoline, an ergot derivative, is a long-acting dopamine agonist and prolactin inhibitor. It is used to treat hyperprolactinemic disorders and Parkinsonian Syndrome. Cabergoline possesses potent agonist activity on dopamine D2 receptors.

Indication

For the treatment of hyperprolactinemic disorders, either idiopathic or due to prolactinoma (prolactin-secreting adenomas). May also be used to manage symptoms of Parkinsonian Syndrome as monotherapy during initial symptomatic management or as an adjunct to levodopa therapy during advanced stages of disease.

Associated Conditions

Hyperprolactinemia
Idiopathic hyperprolactinemic disorder

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Cabergoline for Episodic Migraine	2025/07/18	NCT07072910	Not Applicable	Not yet recruiting	University of Aarhus
Clinical Study to Evaluate Efficacy of Cabergoline to Coasting in Reducing the Incidence of Ovarian Hyperstimulation Syndrome	2025/06/29	NCT07043322	Not Applicable	Recruiting	Tanta University
Cabergoline in the Management of Nonfunctioning Pituitary Adenoma	2025/06/24	NCT07034859	Phase 4	ENROLLING_BY_INVITATION	National Taiwan University Hospital
A Reduced Dose of Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss	2025/04/03	NCT06909123	Phase 2	Not yet recruiting	Stanford University
Non-surgical Interventions for Infertility in Endometriosis	2024/08/19	NCT06560814	Phase 2	Completed	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion	2023/11/08	NCT06123026	Phase 4	Recruiting	Northwestern University
Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss	2023/09/08	NCT06029673	Phase 2	ENROLLING_BY_INVITATION	Stanford University
Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS	2023/08/08	NCT05981742	Phase 2	Completed	Al-Rasheed University College
Cabergoline as a Preventive Treatment for Chronic Migraine	2022/09/01	NCT05525611	Not Applicable	Completed	University of Aarhus
Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline	2021/08/27	NCT05024422	Not Applicable	Completed	HaEmek Medical Center, Israel

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Cabergoline	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-823	ORAL	0.5 mg in 1 1	6/17/2022
Cabergoline	Teva Pharmaceuticals USA, Inc.	0093-5420	ORAL	0.5 mg in 1 1	7/31/2020
Cabergoline	Ingenus Pharmaceuticals, LLC	50742-118	ORAL	0.5 mg in 1 1	1/31/2024
Cabergoline	A-S Medication Solutions	50090-3951	ORAL	0.5 mg in 1 1	11/12/2019
Cabergoline	A-S Medication Solutions	50090-6596	ORAL	0.5 mg in 1 1	6/17/2022
Cabergoline	SOLA Pharmaceuticals, LLC	70512-860	ORAL	0.5 mg in 1 1	5/15/2023
Cabergoline	Greenstone LLC	59762-1005	ORAL	0.5 mg in 1 1	11/28/2022
Cabergoline	Mylan Pharmaceuticals Inc.	59762-1005	ORAL	0.5 mg in 1 1	11/28/2022
Cabergoline	A-S Medication Solutions	50090-5834	ORAL	0.5 mg in 1 1	11/19/2019
Cabergoline	A-S Medication Solutions	50090-3157	ORAL	0.5 mg in 1 1	7/31/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
DOSTINEX TABLET 0.5 mg	Pfizer Italia S.r.l.	SIN09545P	TABLET	0.5 mg	11/21/1997

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
BERGOLINE cabergoline 2mg tablets bottle	132563	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	4/7/2008
CABERGOLINE APOTEX cabergoline 500 micrograms tablets bottle	218127	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/20/2015
DOSTINEX cabergoline 0.5mg tablet bottle	52158	Pfizer Australia Pty Ltd	Medicine	A	4/21/1995
CABASER Cabergoline 1mg tablet bottle	57360	Pfizer Australia Pty Ltd	Medicine	A	10/24/1996
CARBELIN cabergoline 0.5 mg tablet bottle	423450	Nova Pharmaceuticals Australasia Pty Ltd	Medicine	A	9/6/2024
TINEXA cabergoline 0.5mg tablets bottle	132561	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	4/7/2008
BERGOLINE cabergoline 1mg tablets bottle	132562	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	4/7/2008
CABASER Cabergoline 2mg tablet bottle	57367	Pfizer Australia Pty Ltd	Medicine	A	10/24/1996
GenRx Cabergoline cabergoline 500 micrograms tablets bottle	218128	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/20/2015
DOSTAMINE cabergoline 0.5 mg tablet bottle	423451	Nova Pharmaceuticals Australasia Pty Ltd	Medicine	A	9/6/2024

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
JAMP CABERGOLINE	Jamp Pharma Corporation	02549611	Tablet - Oral	0.5 MG	2/4/2025
ACT CABERGOLINE	teva canada limited	02301407	Tablet - Oral	0.5 MG	11/6/2007
CABERGOLINE	Cobalt Pharmaceuticals Company	02344890	Tablet - Oral	0.5 MG	N/A
APO-CABERGOLINE	Apotex Inc	02455897	Tablet - Oral	0.5 MG	3/23/2017
DOSTINEX	Pfizer Canada Ulc	02242471	Tablet - Oral	0.5 MG	6/30/2000

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
DOSTINEX 0,5 mg COMPRIMIDOS	Pfizer S.L.	60867	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
CABERGOLINA TEVA 2 mg COMPRIMIDOS EFG	Teva Pharma S.L.U.	69686	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
CABERGOLINA TEVA 1 mg COMPRIMIDOS EFG	Teva Pharma S.L.U.	69687	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
SOGILEN 1 mg COMPRIMIDOS	Pfizer S.L.	64408	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
SOGILEN 2 mg COMPRIMIDOS	Pfizer S.L.	64409	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
CABERGOLINA TEVA 0,5 mg COMPRIMIDOS EFG	Teva Pharma S.L.U.	69669	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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