Piribedil Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials sponsored by Desitin Arzneimittel GmbH have evaluated the therapeutic application of piribedil in patients with Parkinson's disease, with all studies reaching completed recruitment status. Conducted in settings where formal trial phases were not assigned, these trials assessed long-term treatment efficacy, patient quality-of-life parameters, and regimen stabilization. Collectively, these studies provide valuable post-marketing surveillance data regarding the clinical management and safety outcomes associated with piribedil administration.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01519856	Completed	Parkinson''s Disease	Desitin Arzneimittel GmbH	2009-06	--
NCT00725478	Completed	Parkinson''s Disease	Desitin Arzneimittel GmbH	2008-01	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Piribedil functions as a selective agonist of dopamine D2 and D3 receptors while acting as an antagonist at alpha-2A and alpha-2C adrenergic receptors, thereby stimulating downstream post-synaptic dopaminergic signaling cascades. This dual receptor modulation enhances central dopaminergic neurotransmission, which effectively alleviates motor dysfunction in Parkinson'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>).