SCH-23390 hydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 357
25mg	USD 897

Clinical Trials

A completed Phase 1 clinical trial sponsored by Pfizer investigated SCH-23390 hydrochloride in healthy volunteers, utilizing positron emission tomography to evaluate dopamine D1 receptor occupancy and target engagement following single-dose administration. Overall, the clinical trial landscape for this compound remains limited to early-phase translational research and neuroimaging applications in healthy populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02124213	COMPLETED	Healthy	Pfizer	2014-09	PHASE1

(data from https://clinicaltrials.gov, updated on 2014-12-17)

Check the SCH-23390 hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SCH-23390 hydrochloride acts as a potent, selective dopamine D1-like receptor antagonist that binds with high affinity to D1 and D5 receptor subtypes, thereby blocking downstream dopamine-mediated signaling cascades and directly inhibiting inwardly rectifying potassium channels. This selective receptor antagonism prevents dopamine-induced G protein activation to modulate neuronal signaling, establishing its clinical utility for assessing dopamine D1 receptor occupancy and neuroreceptor binding in healthy individuals.

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>).