Nepicastat (SYN-117) HCl Clinical Trials

Size	Price	Qty
5mg	USD 170

Clinical Trials

Multiple clinical trials have evaluated nepicastat across Phase 1 and Phase 2 studies, focusing primarily on psychiatric and substance use disorders, specifically cocaine dependence and post-traumatic stress disorder. Supported by government-affiliated institutions and industry sponsors—including the National Institute on Drug Abuse and Biotie Therapies Inc.—several clinical trials completed recruitment to evaluate safety, tolerability, and therapeutic efficacy, while a clinical trial was ultimately withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01704196	COMPLETED	Cocaine Dependence	National Institute on Drug Abuse (NIDA)	2013-04	PHASE2
NCT00659230	COMPLETED	Posttraumatic Stress Disorder	Tuscaloosa Research & Education Advancement Corporation	2009-07-01	PHASE2
NCT00641511	WITHDRAWN	Post Traumatic Stress Disorder (PTSD)	Michael E. DeBakey VA Medical Center	2008-06	PHASE2
NCT00656357	COMPLETED	Cocaine Dependence	Biotie Therapies Inc.	2008-06	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2017-05-18)

Check the Nepicastat (SYN-117) HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nepicastat selectively inhibits dopamine β-hydroxylase, preventing the enzymatic conversion of dopamine into norepinephrine and thereby altering central and peripheral catecholamine balances. This targeted reduction in noradrenergic neurotransmission coupled with elevated dopaminergic tone modulates central stress responses and reward circuitry, providing potential therapeutic utility in managing cocaine dependence and post-traumatic stress disorder.

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>).