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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 23 indications[4].[1]

Dostinex is one of 347 small molecule programs targeting Type 2 Diabetes Mellitus. It is currently in Approved.

23

Indications

55

Total Trials

11

Active Trials

346

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Type 2 Diabetes MellitusActive, not recruiting

Parkinson DiseaseActive, not recruiting

ObesityApproved

Pituitary-Dependent Cushing's DiseaseApproved

Migraine DisorderApproved

Prolactin-Producing Pituitary Gland AdenomaActive, not recruiting

Increased Circulating Prolactin ConcentrationActive, not recruiting

Hypothalamic NeoplasmActive, not recruiting

Diabetes MellitusApproved

Reproductive System DiseaseApproved

Type 2 Diabetes MellitusPreclinical

Active, not recruiting

Parkinson DiseaseApproved

Active, not recruiting

ObesityApproved

Approved

Pituitary-Dependent Cushing's DiseaseApproved

Approved

Migraine DisorderApproved

Approved

Prolactin-Producing Pituitary Gland AdenomaPreclinical

Active, not recruiting

Increased Circulating Prolactin ConcentrationApproved

Active, not recruiting

Hypothalamic NeoplasmApproved

Active, not recruiting

Diabetes MellitusApproved

Approved

Reproductive System DiseaseApproved

Approved

Showing 10 of 22 indications

Competition

Competitive Landscape

190 competitors in Obesity

#DrugCompanyPhaseTrials

Dostinex

Cagrilintide

Retatrutide

NNC0487-0111

Gemtesa

Sumitomo Pharma America, Inc.

Zenagamtide

Berobenatide

Ribupatide

PF-08653944

Survodutide

Boehringer Ingelheim

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

Q2 2028

Phase 2Recruiting

Abortion

NCT07492160

Q3 2028

Phase 2Recruiting

Migraine

NCT07072910

Q4 2028

Phase 3Active, not recruiting

Pituitary Neoplasms

NCT02288962

Clinical

Trials by Indication[1]

Ovarian Hyperstimulation Syndrome8 trials

Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

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

Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

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

Show 5 more trials

Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention

Completed·—·Phase 3·NCT03473613·230 enrolled

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

Completed·—·Phase 2·NCT02875587·170 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

Ovarian Hyperstimulation Syndrome and Cabergoline

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

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

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

Adenoma4 trials

Cabergoline in Nonfunctioning Pituitary Adenomas

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

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

Cabergoline in the Management of Nonfunctioning Pituitary Adenoma

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

Show 1 more trial

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

Parkinson's Disease3 trials

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

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

Efficacy and Safety3 trials

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

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

Abortion3 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

Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms After 12-18 Week Abortion or Pregnancy Loss: A Pilot and Randomized Controlled Trial

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

29 more indications

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

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

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

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

Lactation1 trial

Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline

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

Tolerance1 trial

Effect of Cabergoline on Weight and Glucose Tolerance

Completed·—·Phase 1/2·NCT01395602·40 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

Tics1 trial

Cabergoline Effect on Blood Sugar in Type 2 Diabetics

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

Complication1 trial

Cardiac Valve Complications in Prolactinomas Treated With Cabergoline

Completed·FFederico II University··NCT00460616·50 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

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

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

Pregnancy1 trial

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

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

Hyperprolactinemia1 trial

Carbergoline for Antipsychotic Induced Hyperprolactinemia.

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

Pituitary Tumor1 trial

Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

Completed·—·Phase 3·NCT00889525

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

Fasting Conditions1 trial

Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fasting Conditions

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

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

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

Fed1 trial

Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions

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

Erectile Dysfunctions1 trial

An Open-Label Single-Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Viaca (Sildenafil + Cabergoline) Compared With Sildenafil and Cabergoline in Healthy Volunteers

Not yet recruiting·YYanping Kong·Phase 1·NCT07732387·30 enrolled

Pituitary Neoplasms1 trial

Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas (NFPAs) - a Randomized Controlled Trial

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

Lactation Suppressed1 trial

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

Withdrawn·SStanford University·Phase 2·NCT06909123

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 — 55 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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