SCH-442416 Clinical Trials

Size	Price	Qty
5mg	USD 329
25mg	USD 987

Clinical Trials

The clinical trial landscape for SCH-442416 includes Phase 1 studies sponsored by Biogen to evaluate central adenosine A2A brain receptor occupancy in healthy volunteers. Multiple clinical trials utilized positron emission tomography imaging across various dose levels to measure receptor binding parameters directly within human subjects. These Phase 1 trials have completed recruitment, yielding critical data regarding the compound's central target interaction and receptor occupancy profile.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00531193	COMPLETED	Healthy	Biogen	2007-09	PHASE1
NCT00531193	Completed	Healthy	Biogen	2007-09	Phase 1

(data from https://clinicaltrials.gov, updated on 2008-07-30)

Check the SCH-442416 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SCH-442416 selectively binds to the adenosine A2A receptor with high affinity, thereby blocking receptor activation and inhibiting downstream cyclic adenosine monophosphate signaling cascades. This molecular inhibition alters cellular responses within adenosine-responsive neural tissues, providing the mechanistic rationale for its clinical evaluation in assessing central receptor occupancy in healthy subjects.

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>).