Clinical Trials

Numerous clinical trials evaluate the therapeutic profile of bromocriptine mesylate across indications including Parkinson's disease, type 2 diabetes, diabetic macular edema, peripartum cardiomyopathy, and traumatic brain injury. Spanning early phase through Phase 4 research, these studies encompass completed, recruiting, and withdrawn recruitment statuses. The research is supported by pharmaceutical sponsors alongside academic and medical institutions, featuring completed late-stage trials in Parkinson's disease and active investigations into cardiovascular recovery.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05180773 RECRUITING
Peripartum Cardiomyopathy, Postpartum
Dennis M. McNamara, MD, MS
 2022-07-27 PHASE4
NCT07124221 RECRUITING
Hyperprolactinemia
Changchun GeneScience Pharmaceutical Co., Ltd.
 2025-09-12 PHASE3
NCT03575000 NOT_YET_RECRUITING
Schizophrenia; PreDiabetes
VA Pittsburgh Healthcare System
 2026-01-01 PHASE4
NCT06250257 RECRUITING
Dilated Cardiomyopathy
Jimma University
 2024-10-21 PHASE3
NCT03525002 COMPLETED
Obesity
University Hospital Tuebingen
 2018-05-03 PHASE2
NCT04128683 COMPLETED
Anorexia Nervosa
University of California, San Diego
 2020-10-20 EARLY_PHASE1
NCT04674670 COMPLETED
Fibromyalgia; Pain, Chronic; Chronic Pain, Widespread
susanne becker
 2021-11-01
NCT02590601 WITHDRAWN
Peripartum Cardiomyopathy
Montreal Heart Institute
 2017-01-01 PHASE3
NCT04038749 UNKNOWN
Lactation Suppressed
Żelazna Medical Centre, LLC
 2019-06-16
NCT04413344 COMPLETED
Familial Alzheimer Disease (FAD); PSEN1 Mutation
Kyoto University
 2020-06-05 PHASE1; PHASE2
NCT04351126 COMPLETED
Ovarian Hyperstimulation Syndrome
Ganin Fertility Center
 2019-04-01 PHASE2
NCT04181385 UNKNOWN
Healthy
University Health Network, Toronto
 2019-01-01 PHASE2; PHASE3
NCT03496545 COMPLETED
Subarachnoid Hemorrhage; Subdural Hematoma; Traumatic Brain Injury; Ischemic Stroke; Fever; Intracerebral Hemorrhage
University of California, San Francisco
 2018-11-30 PHASE1; PHASE2
NCT05405244 COMPLETED
Overweight and Obesity; Eating Behavior
University of North Carolina, Chapel Hill
 2017-09-19 PHASE3
NCT02544321 COMPLETED
Type 1 Diabetes
University of Colorado, Denver
 2015-09 PHASE2
NCT03384524 WITHDRAWN
Diabetic Macular Edema
Andrew Moshfeghi, MD, MBA
 2018-03 PHASE1; PHASE2
NCT02682901 COMPLETED
Diabetic Autonomic Neuropathy
Eastern Virginia Medical School
 2015-10-05 PHASE4
NCT02846493 UNKNOWN
Ovarian Hyperstimulation Syndrome
Sun Yat-sen University
 2016-08 PHASE2
NCT02929485 WITHDRAWN
Addiction
University of California, Berkeley
 2013-07 PHASE4
NCT01821001 COMPLETED
Adenomyosis
Mayo Clinic
 2013-03 PHASE1
NCT02078440 COMPLETED
Type 2 Diabetes
VeroScience
 2014-01 PHASE1
NCT01673724 COMPLETED
Parkinson's Disease
Sandoz
 2012-02 PHASE4
NCT00998556 COMPLETED
Peripartum Cardiomyopathy
Hannover Medical School
 2010-06 PHASE2
NCT02428946 COMPLETED
Insulin Sensitivity
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2014-10
NCT02133755 UNKNOWN
PCOS; Insulin Resistance
IWK Health Centre
 2014-07 PHASE3
NCT02265484 COMPLETED
Cirrhosis Related Parkinsonism
Institute of Liver and Biliary Sciences, India
 2013-11
NCT02428933 COMPLETED
Obesity
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2013-10
NCT01893450 TERMINATED
Graves Ophthalmopathy
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2008-06
NCT01474018 COMPLETED
Diabetes Mellitus, Type 2
University of Texas Southwestern Medical Center
 2011-11 PHASE4
NCT00650520 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2007-05 PHASE1
NCT00649168 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2007-04 PHASE1
NCT00441363 TERMINATED
Type 2 Diabetes
VeroScience
 2005-02 PHASE3
NCT00240409 COMPLETED
Parkinson Disease
Boehringer Ingelheim
 2003-07 PHASE3
NCT02172573 COMPLETED
Parkinson Disease
Boehringer Ingelheim
 1999-04 PHASE3
NCT02233023 COMPLETED
Parkinson Disease
Boehringer Ingelheim
 1998-06 PHASE4
NCT00451672 UNKNOWN
Hyperaldosteronism; Hypertension
National Taiwan University Hospital
 2007-01 PHASE4
NCT00004300 SUSPENDED
Stereotyped Behavior; Mental Retardation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 PHASE2
NCT00315081 UNKNOWN
Schizophrenia; Hyperprolactinemia
University Hospital, Bonn
 2006-05 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-10)

Check the Bromocriptine Mesylate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bromocriptine mesylate functions as a potent dopamine receptor agonist with nanomolar affinity for D2 and D3 receptors, modulating downstream adenylate cyclase activity and suppressing prolactin secretion in pituitary cells. By restoring central dopaminergic tone and altering neuroendocrine signaling pathways, this action alleviates motor deficits in Parkinson's disease, improves metabolic regulation in type 2 diabetes, and limits prolactin-driven pathology in peripartum cardiomyopathy.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.