Pridopidine Clinical Trials

Size	Price	Qty
5mg	USD 79
25mg	USD 237

Clinical Trials

A completed Phase 1 clinical trial, sponsored by industry sponsor Prilenia, evaluated the dopamine stabilizer pridopidine in healthy volunteers and patients with Huntington's disease. This open-label study utilized single-dose adaptive positron emission tomography imaging to assess target engagement at the sigma-1 and dopamine D2 receptors. These findings provide valuable human baseline data regarding central nervous system target binding and occupancy, supporting the ongoing clinical assessment of pridopidine for neurodegenerative conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03019289	Completed	Health Volunteers Huntington Disease	Prilenia	2017-04-19	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pridopidine acts as a dopamine stabilizer that antagonizes the sigma-1 receptor and dopamine D2 receptor, thereby modulating downstream dopaminergic and neuroprotective signaling pathways to regulate neuronal cellular homeostasis. This receptor-targeted stabilization of central neurochemistry helps preserve cellular survival, providing the mechanistic rationale for its clinical investigation in patients with Huntington's disease.

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>).