Clinical Trials

Numerous clinical trials evaluate raclopride as a molecular radiotracer to investigate central dopaminergic pathways across healthy cohorts and diverse conditions, including obesity, major depressive disorder, traumatic brain injury, developmental stuttering, eating disorders, and psychosis risk. Spanning Early Phase 1 through Phase 4 alongside observational imaging protocols, these studies are sponsored by academic medical centers and federal agencies, including the NIDDK and NINDS. Featuring completed, recruiting, terminated, and withdrawn statuses, this research focuses on key areas such as reward processing and striatal dopamine receptor availability.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07559500 RECRUITING
Alcohol Use Disorder (AUD)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 2026-05-20 PHASE1
NCT06977308 NOT_YET_RECRUITING
Clinical High Risk for Psychosis (CHR)
New York State Psychiatric Institute
 2026-10-01 PHASE1
NCT05282277 RECRUITING
Depression; Psychosis; Anhedonia
University of North Carolina, Chapel Hill
 2022-04-20 PHASE4
NCT03190954 COMPLETED
Normal Physiology; Opioid Use Disorders
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 2017-08-17 EARLY_PHASE1
NCT02169310 COMPLETED
Traumatic Brain Injury
National Institute of Neurological Disorders and Stroke (NINDS)
 2014-11-18 PHASE1
NCT03637075 COMPLETED
Diabetes Mellitus, Type 2
University Hospital Tuebingen
 2017-02-20
NCT05359887 Recruiting
Obesity
University Medical Center Groningen
 2022-12-01 Not Applicable
NCT03648892 COMPLETED
Obesity; Healthy Volunteers; Overweight
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2018-09-21 EARLY_PHASE1
NCT03648892 Completed
Obesity|Healthy Volunteers|Overweight
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|National Institutes of Health Clinical Center (CC)
 2018-09-21 Early Phase 1
NCT02020408 COMPLETED
Eating Disorder
University of California, San Diego
 2011-05 PHASE4
NCT02744391 Completed
Major Depressive Disorder|Dysthymia|Depression Not Otherwise Specified|Decreased Processing Speed|Decreased Gait Speed
New York State Psychiatric Institute
 2016-08-24 Phase 4
NCT03026036 Completed
Major Depressive Disorder
Mclean Hospital
 2016-04 --
NCT02152670 TERMINATED
Cocaine Dependence
Yale University
 2014-05
NCT00396669 UNKNOWN
Tobacco Use Disorder
Hadassah Medical Organization
 2007-07
NCT00953745 COMPLETED
Major Depressive Disorder
Washington University School of Medicine
 2009-05
NCT00846339 COMPLETED
Smoking
Seoul National University Hospital
 2008-11 PHASE4
NCT00562198 TERMINATED
Parkinson´s Disease
Orion Corporation, Orion Pharma
 2008-01 PHASE2
NCT00015301 COMPLETED
Cocaine-Related Disorders; Substance-Related Disorders
National Institute on Drug Abuse (NIDA)
 2003-12 PHASE4
NCT00480246 COMPLETED
Healthy
BioLineRx, Ltd.
 2007-05 PHASE1
NCT00832221 COMPLETED
Depression
AstraZeneca
 2009-01 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-28)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Raclopride selectively binds to dopamine D2 and D3 receptors with high nanomolar affinity, competitively antagonizing endogenous dopamine binding and inhibiting downstream G protein-mediated signaling pathways in central dopaminergic neurons. By modulating striatal D2/D3 receptor availability, this targeted blockade alters neurotransmission involved in motor control and reward pathways, providing a critical mechanism for imaging receptor occupancy and neurocircuitry alterations in clinical conditions such as obesity, major depressive disorder, and traumatic brain injury.

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.