Deudextromethorphan (AVP-786) Clinical Trials

Size	Price	Qty
5mg	USD 229
25mg	USD 687

Clinical Trials

Multiple clinical trials sponsored primarily by Otsuka Pharmaceutical Development & Commercialization Inc. and Avanir Pharmaceuticals have evaluated deudextromethorphan (AVP-786) across Phase 1 and Phase 3 development. Completed early-stage Phase 1 studies in healthy volunteers established the compound's pharmacokinetics, drug-drug interaction profiles, safety, and tolerability. Advanced clinical development includes actively recruiting Phase 3 testing to evaluate the long-term safety and efficacy of AVP-786 in managing agitation in patients with dementia of the Alzheimer's type.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02446132	Recruiting	Agitation in Patients With Dementia of the Alzheimer''s Type	Otsuka Pharmaceutical Development & Commercialization Inc.	2015-12	Phase 3
NCT02402595	Completed	Healthy	Avanir Pharmaceuticals	2015-03	Phase 1
NCT02336347	Completed	Healthy Volunteer	Avanir Pharmaceuticals	2014-05	Phase 1
NCT02174822	Completed	Drug-drug Interaction	Otsuka Pharmaceutical Development & Commercialization Inc.	2014-01	Phase 1
NCT02174835	Completed	Healthy	Avanir Pharmaceuticals	2013-09	Phase 1

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

Check the Deudextromethorphan (AVP-786) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Deudextromethorphan (AVP-786) acts as an antagonist of the N-methyl-D-aspartate receptor, binding to the receptor complex to block excessive glutamate-induced excitation and attenuate downstream intracellular calcium influx. This suppression of overactive glutamatergic signaling stabilizes hyperexcitable neural circuitry, providing the mechanistic basis for reducing central neurobehavioral disruption and mitigating agitation in patients with dementia of the Alzheimer's type.

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>).