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Dostinex

(Cabergoline)

ApprovedSmall molecule

Cabergoline is used to treat high levels of a hormone called prolactin in the body, which can cause problems like unwanted milk production, irregular periods, or fertility issues. It's also used to treat certain pituitary tumors that produce this hormone.[2] Dostinex is currently approved and in use across 26 indications[4].[1]

Dostinex is one of 479 small molecule programs targeting Hyperprolactinemia. It is currently in Approved.

26

Indications

54

Total Trials

11

Active Trials

478

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

HyperprolactinemiaActive, not recruiting

Migraine DisorderApproved

AdenomaActive, not recruiting

Increased Circulating Prolactin ConcentrationActive, not recruiting

AbortionActive, not recruiting

Type 2 Diabetes MellitusActive, not recruiting

Restless Legs SyndromeApproved

Parkinson DiseaseActive, not recruiting

Hypothalamic NeoplasmActive, not recruiting

Cocaine DependenceActive, not recruiting

HyperprolactinemiaApproved

Active, not recruiting

Migraine DisorderApproved

Approved

AdenomaApproved

Active, not recruiting

Increased Circulating Prolactin ConcentrationApproved

Active, not recruiting

AbortionPhase 2

Active, not recruiting

Type 2 Diabetes MellitusPreclinical

Active, not recruiting

Restless Legs SyndromeApproved

Approved

Parkinson DiseaseApproved

Active, not recruiting

Hypothalamic NeoplasmApproved

Active, not recruiting

Cocaine DependencePhase 2

Active, not recruiting

Showing 10 of 25 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Dostinex

Halaven

Tykerb

Adriamycin

GGynecologic Oncology Group

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Prolia

Gemzar

GGynecologic Oncology Group

MS Contin

Lupron

EEastern Cooperative Oncology Group

MS Contin

HHikma Pharmaceuticals LLC

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Ovarian Hyperstimulation Syndrome

NCT07043322

Phase 3Recruiting

Phase II

NCT07124221

Q3 2027

Phase 2Not yet recruiting

Pregnancy

NCT06909123

Q2 2028

Phase 2Recruiting

Lactation

NCT07492160

Q3 2028

Phase 2Recruiting

Migraine

NCT07072910

Clinical

Trials by Indication[1]

Ovarian Hyperstimulation Syndrome8 trials

Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome

Completed·—·Phase 2·NCT02875587·170 enrolled

Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

Completed·—·Phase 2/3·NCT02271360·200 enrolled

Clinical Study to Evaluate Efficacy of Cabergoline to Coasting in Reducing the Incidence of Ovarian Hyperstimulation Syndrome

Recruiting·TTanta University·Phase 2·NCT07043322·150 enrolled

Show 5 more trials

Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention

Completed·—·Phase 3·NCT03473613·230 enrolled

Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

Completed·—·Phase 2/3·NCT02134249·200 enrolled

Cabergoline Versus GnRH Antagonist Rescue and Cabergoline in the Prevention of Ovarian Hyperstimulation Syndrome

Unknown status·—·Phase 2·NCT02461875·236 enrolled

Ovarian Hyperstimulation Syndrome and Cabergoline

Completed·EEtlik Zubeyde Hanim Womens' Health and Teaching Hospital·N/A·NCT01569256·40 enrolled

Study of Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in In Vito Fertilization Cycles and Derivation of OHSS Biomarkers

Completed·KKK Women's and Children's Hospital·Phase 3·NCT01535859·46 enrolled

Adenoma5 trials

Response to Cabergoline and Pasireotide in Non-functioning Pituitary Adenomas and Resistant Prolactinomas

Completed·UUniversidade Federal do Rio de Janeiro·Phase 2/3·NCT01620138·21 enrolled

Efficacy of Rapid Escalation of Cabergoline in Comparison to Conventional Dosing in Prolactin Secreting Macroadenomas.

Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·N/A·NCT01143584·20 enrolled

Cabergoline in Nonfunctioning Pituitary Adenomas

Completed·UUniversity of Sao Paulo General Hospital·Phase 3·NCT03271918·140 enrolled

Show 2 more trials

Cabergoline in the Management of Nonfunctioning Pituitary Adenoma

Enrolling by invitation·NNational Taiwan University Hospital·Phase 4·NCT07034859·30 enrolled

Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas

Active, not recruiting·SSt. Olavs Hospital·Phase 3·NCT02288962·60 enrolled

Efficacy and Safety3 trials

A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS

Completed· Pfizer logo

Pfizer·Phase 3·NCT00625547·361 enrolled

A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS

Completed· Pfizer logo

Pfizer·Phase 3·NCT00627003·43 enrolled

Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients

Completed· Novartis logo

Novartis·Phase 4·NCT01278342·70 enrolled

Treatment3 trials

Short and Long Term Efficacy of Combined Cabergoline and Octreotide Treatment in Acromegalic Patients

Completed·FFederal University of São Paulo··NCT01014793·19 enrolled

Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment

Recruiting·UUniversity Hospital, Basel, Switzerland·Phase 4·NCT07045935·60 enrolled

Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies

Completed·RRECORDATI GROUP·Phase 4·NCT01794793·337 enrolled

Parkinson's Disease3 trials

Dopamine Turnover Rate as Surrogate Parameter for Diagnosis of Early Parkinson's Disease

Completed·TTechnische Universität Dresden·Phase 4·NCT00153972·39 enrolled

Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease

Completed·IInstitute for Neurodegenerative Disorders·N/A·NCT00129181·30 enrolled

Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.

Terminated· Pfizer logo

Pfizer·Phase 4·NCT00174239·220 enrolled

26 more indications

Pregnancy2 trials

A Reduced Dose of Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss

Not yet recruiting·SStanford University·Phase 2·NCT06909123·36 enrolled

Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss

Completed·SStanford University·Phase 2·NCT06029673·69 enrolled

Endometriosis2 trials

Dopamine Receptor Agonist Therapy for Pain Relief in Women Suffering From Endometriosis: A Pilot Study

Completed·—·Phase 2·NCT02542410·10 enrolled

Cabergoline for the Treatment of Chronic Pain Due to Endometriosis

Completed·—·Phase 2·NCT03928288·129 enrolled

Cocaine Dependence2 trials

A Study of Cabergoline for the Treatment of Cocaine Dependence - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00033111·140 enrolled

A Pilot Study of Cabergoline for the Treatment of Cocaine Dependence

Completed·—·Phase 1·NCT01651364·11 enrolled

Lactation2 trials

Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline

Completed·HHaEmek Medical Center, Israel·N/A·NCT05024422·89 enrolled

Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms

Recruiting·MMaimonides Medical Center·Phase 2·NCT07492160·348 enrolled

Abortion2 trials

Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion

Recruiting·NNorthwestern University·Phase 4·NCT06123026·200 enrolled

Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Loss

Completed·SStanford University·Phase 2·NCT04701333·73 enrolled

Migraine2 trials

Cabergoline for Episodic Migraine

Recruiting·—·Phase 2·NCT07072910·150 enrolled

Cabergoline as a Preventive Treatment for Chronic Migraine

Completed·UUniversity of Aarhus·N/A·NCT05525611·36 enrolled

Fasting Conditions1 trial

Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fasting Conditions

Completed·PPar Pharmaceutical, Inc.·Phase 1·NCT00653055·40 enrolled

Polycystic Ovary Syndrome1 trial

Clomiphene Citrate Plus Cabergoline in Treatment of Polycystic Ovary Syndrome

Unknown status·WWoman's Health University Hospital, Egypt·Phase 2·NCT02644304·88 enrolled

Treatment Outcome1 trial

Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma

Unknown status·SSeoul National University Hospital·N/A·NCT03457389·68 enrolled

Complication1 trial

Cardiac Valve Complications in Prolactinomas Treated With Cabergoline

Completed·FFederico II University··NCT00460616·50 enrolled

Aspirin1 trial

Value of Cabergoline and Low Dose Aspirin in Poor Responders Undergoing ICSI-ET With GnRH Agonist Flare-Up-Protocol

Unknown status·—·Phase 4·NCT03263299·120 enrolled

Tics1 trial

Cabergoline Effect on Blood Sugar in Type 2 Diabetics

Unknown status·MMashhad University of Medical Sciences·N/A·NCT01459601·10 enrolled

Breast Cancer1 trial

Cabergoline in Metastatic Breast Cancer

Completed·NNorthwestern University·Phase 1·NCT01730729·20 enrolled

Satisfaction1 trial

Satisfaction of Patients With the Chosen Method of Inhibition of Lactation

Unknown status·—·N/A·NCT04038749·90 enrolled

Age1 trial

Safety and Potency of a High Cabergoline Dosage in Microprolactinomas

Recruiting·UUniversity of Sao Paulo General Hospital·Phase 3·NCT07463235·70 enrolled

Fed1 trial

Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions

Completed·PPar Pharmaceutical, Inc.·Phase 1·NCT00652873·24 enrolled

Tolerance1 trial

Effect of Cabergoline on Weight and Glucose Tolerance

Completed·—·Phase 1/2·NCT01395602·40 enrolled

Intracytoplasmic Sperm Injection1 trial

Effect of Cabergoline on Endometrial Vascularity During IntraCytoplasmic Sperm Injection

Unknown status·KKasr El Aini Hospital·Phase 2/3·NCT02306564·150 enrolled

Metformin1 trial

Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS

Completed·—·Phase 2·NCT05981742·75 enrolled

Phase II1 trial

A Phase III Clinical Study of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets

Recruiting· Changchun GeneScience Pharmaceutical Co., Ltd. logo

Changchun GeneScience Pharmaceutical Co., Ltd.·Phase 3·NCT07124221·382 enrolled

Infertility1 trial

Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility

Unknown status·—·Phase 2/3·NCT03549741·120 enrolled

Hyperprolactinemia1 trial

Carbergoline for Antipsychotic Induced Hyperprolactinemia.

Not yet recruiting·ZZealand University Hospital·Phase 4·NCT07386080·146 enrolled

T2DM1 trial

Co-administration of Cabergoline and Gliclazide Improve Glycemic Parameters and Lipid Profile in T2DM Patients

Unknown status·SSherief Abd-Elsalam·Phase 3·NCT03313661·60 enrolled

Pituitary Tumor1 trial

Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

Completed·—·Phase 3·NCT00889525

Assisted Reproductive Technology1 trial

Compare the Efficacy of Human Albumin With Cabergoline to Prevent Ovarian Hyper Stimulation in Assisted Reproductive Technology (ART) Program

Completed·RRoyan Institute·Phase 1/2·NCT01009567·10 enrolled

Unspecified1 trial

Cabergoline Reduces OHSS

Completed·IInstituto Valenciano de Infertilidad, IVI VALENCIA·Phase 3·NCT00440258·60 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 23, 1996

DOSTINEX

NDA NDA020664

Sources

References

[1]
ClinicalTrials.gov — 54 trial records for Cabergoline. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Dostinex drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Cabergoline compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Cabergoline. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020664). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dopamine D2 Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

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