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Compound · clinical trials

Cabergoline clinical trials

Also listed in trial records as Galastop, FCE 21336, Cabaser, Dostinex
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 9 trials in our Denmark, China, Sweden, Norway, Switzerland, Brazil, Taiwan, Australia and Egypt registers that name Cabergoline as an intervention. Synced 27 Sep 2026
9Current trials
5Recruiting now
9Lead sponsors
9Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Cabergoline is named as an intervention in 9 current clinical trials in our Denmark, China, Sweden, Norway, Switzerland, Brazil, Taiwan, Australia and Egypt registers. 5 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Changchun GeneScience Pharmaceutical Co., Ltd (1). The most-studied condition is Prolactinoma. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.

Where Cabergoline is approved

All regulators →

Cabergoline was first approved in the US on 23 Dec 1996. It is approved in 2 of the 3 regulators tracked here.

USUnited States (FDA)
23 Dec 1996
Dostinex
NDA020664 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
30 Jun 2000
Dostinex
Notice of Compliance 1046
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Trials by status

  • Recruiting556%
  • Not yet open222%
  • Active, closed111%
  • By invitation111%

Trials by phase

  • Phase 3333%
  • Phase 4333%
  • Phase 2222%
  • Phase 1111%
01

Clinical trials of Cabergoline

9 trials
StudyPhaseStatusLead sponsorRegisters
Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment
NCT07045935 · ClinicalTrials.gov ↗ · Prolactinoma
Phase 4 Recruiting University Hospital, Basel, Switzerland Switzerland
A Phase III Clinical Study of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets
NCT07124221 · ClinicalTrials.gov ↗ · Hyperprolactinemia
Phase 3 Recruiting Changchun GeneScience Pharmaceutical Co., Ltd China
Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
NCT07463235 · ClinicalTrials.gov ↗ · Prolactinoma, Prolactin Excess
Phase 3 Recruiting University of Sao Paulo General Hospital Brazil
Clinical Study to Evaluate Efficacy of Cabergoline to Coasting in Reducing the Incidence of Ovarian Hyperstimulation Syndrome
NCT07043322 · ClinicalTrials.gov ↗ · Gynecologic Disease
Phase 2 Recruiting Tanta University Egypt
Cabergoline for Episodic Migraine
NCT07072910 · ClinicalTrials.gov ↗ · Migraine
Phase 2 Recruiting Aarhus University Hospital Denmark
Carbergoline for Antipsychotic Induced Hyperprolactinemia.
NCT07386080 · ClinicalTrials.gov ↗ · Scizophrenia
Phase 4 Not yet open Zealand University Hospital Denmark
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Viaca (Sildenafil + Cabergoline) Compared With Sildenafil and Cabergoline
NCT07732387 · ClinicalTrials.gov ↗ · Erectile Dysfunctions, Healthy Volunteer
Phase 1 Not yet open Yanping Kong Australia
Cabergoline in the Management of Nonfunctioning Pituitary Adenoma
NCT07034859 · ClinicalTrials.gov ↗ · Pituitary Adenoma, MRI, RCT
Phase 4 By invitation National Taiwan University Hospital Taiwan
Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas
NCT02288962 · ClinicalTrials.gov ↗ · Pituitary Neoplasms, Adenoma
Phase 3 Active, closed St. Olavs Hospital Sweden, Norway

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Cabergoline in the EU trials register (CTIS)

2 trials

Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Cabergoline. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.

StudyPhaseStatusSponsorCountries
Prevention and Treatment of Episodic migraine by Cabergoline Therapy (PROTECT) A randomized, placebo-controlled, double-blind, investigator-initiated trial
2025-522323-10-00 · CTIS ↗ · Nervous System Diseases
Phase 3 Ongoing Region Midtjylland Denmark
CARESS Study: Cabergoline for the Reduction of Endometriosis Symptoms and Lesion Size
2025-522812-18-00 · CTIS ↗ · Female Urogenital Diseases and Pregnancy Complications
Phase 3 Authorised Hospital Clinico San Carlos Spain
03

Cabergoline across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

8 single-substance products containing Cabergoline on the HPRA medicines list.

All 8 Irish products →

Supply shortages

  • Cabaseril 1 mgGermany (BfArM) · Other reason · 1 Jun 2026 to 16 Oct 2026
  • Cabaseril 1 mgGermany (BfArM) · Other reason · 1 Jun 2026 to 16 Oct 2026
  • Cabaseril 2 mgGermany (BfArM) · Other reason · 1 Jun 2026 to 16 Oct 2026
  • Cabaseril 2 mgGermany (BfArM) · Other reason · 1 Jun 2026 to 16 Oct 2026
04

Conditions studied with Cabergoline

13 conditions
Prolactinoma2Hyperprolactinemia1Pituitary Neoplasms1Adenoma1Scizophrenia1Migraine1Prolactin Excess1Pituitary Adenoma1MRI1RCT1Erectile Dysfunctions1Healthy Volunteer1
All 13 conditions
Condition (as registered)Trials
Prolactinoma2
Hyperprolactinemia1
Pituitary Neoplasms1
Adenoma1
Scizophrenia1
Migraine1
Prolactin Excess1
Pituitary Adenoma1
MRI1
RCT1
Erectile Dysfunctions1
Healthy Volunteer1
Gynecologic Disease1
05

Sponsors

lead sponsor per trial
Lead sponsorTrials
Changchun GeneScience Pharmaceutical Co., Ltd1
St. Olavs Hospital1
Zealand University Hospital1
Aarhus University Hospital1
University Hospital, Basel, Switzerland1
University of Sao Paulo General Hospital1
National Taiwan University Hospital1
Yanping Kong1
Tanta University1
06

By country register

RegisterTrialsRecruiting
Clinical trials in Denmark21
Clinical trials in China11
Clinical trials in Sweden10
Clinical trials in Norway10
Clinical trials in Switzerland11
Clinical trials in Brazil11
Clinical trials in Taiwan10
Clinical trials in Australia10
Clinical trials in Egypt11
EU register (CTIS)2—

A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.

07

Related compounds

08

Questions about Cabergoline trials

How many clinical trials are testing Cabergoline?

9 current trials in our Denmark, China, Sweden, Norway, Switzerland, Brazil, Taiwan, Australia and Egypt registers name Cabergoline (also registered as FCE 21336) as a drug or biological intervention, as of the registry sync on 27 September 2026. Completed and withdrawn studies are not counted.

Are Cabergoline trials recruiting patients?

Yes. 5 of the 9 trials are recruiting: 1 with sites in Denmark, 1 with sites in China, 1 with sites in Switzerland, 1 with sites in Brazil and 1 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Cabergoline clinical trials?

Changchun GeneScience Pharmaceutical Co., Ltd (1), St. Olavs Hospital (1), Zealand University Hospital (1) and Aarhus University Hospital (1), among 9 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Is Cabergoline licensed in Ireland?

Yes. The HPRA medicines list includes 8 single-substance products containing Cabergoline, for example Cabaser 1 mg Tablet (Pfizer Healthcare Ireland Unlimited Company). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Cabergoline shortage?

The registers we track list 4 entries for Cabergoline: 4 German notices. Shortages are product- and country-specific; check with a pharmacist.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Cabergoline works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Cabergoline works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Cabergoline (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 27 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.