Pramipexole 2HCl Monohydrate Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Multiple clinical trials spanning Phase 1, Phase 2, and Phase 4 evaluate pramipexole formulations across indications including Idiopathic Parkinson's disease, Parkinson's disease with secondary behavioral addiction, major depressive disorder, anxiety disorders with social disconnection, hypereosinophilic syndrome, and healthy volunteer pharmacokinetics. Sponsored by academic medical centers, government entities such as the National Institute of Mental Health and National Institute of Allergy and Infectious Diseases, and industry partners including Chase Therapeutics Corporation and Knopp Biosciences, recruitment across these studies ranges from completed or active, non-recruiting status to trials that are not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06269146	Not yet recruiting	Anxiety Disorders\|Anxiety\|Depression\|Social Disconnection	University of California San Diego\|National Institute of Mental Health (NIMH)\|New York State Psychiatric Institute	2024-02	Phase 2
NCT03683225	Active not recruiting	Idiopathic Parkinson Disease	Chase Therapeutics Corporation	2019-04-01	Phase 2
NCT03642964	Active not recruiting	Major Depressive Disorder (MDD)	Chase Therapeutics Corporation	2018-09-10	Phase 2
NCT02101138	Unknown status	Hypereosinophilic Syndrome	National Institute of Allergy and Infectious Diseases (NIAID)\|Knopp Biosciences\|National Institutes of Health Clinical Center (CC)	2014-03-14	Phase 2
NCT01733199	Completed	Parkinson''s Disease\|Secondary Behavioural Addiction	Nantes University Hospital	2012-10	Phase 4
NCT01607034	Completed	Healthy Volunteers	Knopp Biosciences	2012-06	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Pramipexole 2HCl Monohydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pramipexole functions as a selective agonist of the dopamine D2, D3, and D4 receptors, potently binding to these targets to stimulate downstream G protein-mediated dopaminergic signaling cascades. This activation modulates striatal neuronal excitability and restores synaptic dopamine transmission, mitigating motor dysfunction in Parkinson's disease and addressing neurobehavioral dysregulation in major depressive disorder.

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>).