Preladenant Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 447

Clinical Trials

Multiple clinical trials sponsored by Merck Sharp & Dohme LLC have evaluated the pharmacokinetic properties of preladenant. These completed Phase 1 studies investigated the drug in specific patient populations, including individuals with chronic hepatic impairment, renal impairment, and Parkinson's disease. Overall, these initial clinical investigations establish essential clinical pharmacological properties for this targeted therapy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01465412	Completed	Chronic Hepatic Impairment	Merck Sharp & Dohme LLC	2011-11-10	Phase 1
NCT01323855	Completed	Parkinson Disease	Merck Sharp & Dohme LLC	2011-03-28	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Preladenant functions as a potent and selective competitive antagonist of the human adenosine A2A receptor, binding the target with high affinity (Ki = 1.1 nM) to block adenosine-mediated intracellular cAMP signaling cascades. By suppressing downstream A2A receptor signaling in the basal ganglia, preladenant modulates dopaminergic neurotransmission and motor circuit function, providing therapeutic rationale for its clinical evaluation in neurodegenerative disorders such as 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>).