Ansofaxine hydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 547

Clinical Trials

A completed Phase 1 clinical trial sponsored by Luye Pharma Group Ltd. evaluated Ansofaxine hydrochloride for the treatment of major depression. The study specifically assessed the relative bioavailability of oral tablet formulations of the compound compared to a standard reference antidepressant under fasting conditions. These early-phase clinical data support the therapeutic development of Ansofaxine hydrochloride as an intervention for major depressive disorder.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02988024	Completed	Major Depression	Luye Pharma Group Ltd.	2016-12-07	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ansofaxine hydrochloride acts as a triple reuptake inhibitor that simultaneously binds and inhibits the reuptake transporters for serotonin, dopamine, and norepinephrine with IC50 values of 723 nM, 491 nM, and 763 nM, respectively. By blocking monoamine reuptake into presynaptic neurons, the compound elevates synaptic neurotransmitter concentrations to restore monoaminergic neurotransmission, which provides therapeutic relevance in the management of major depression.

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>).