Encenicline (EVP-6124) hydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 397
25mg	USD 959

Clinical Trials

Several clinical trials spanning Phase 1, Phase 2, and Phase 3 evaluated encenicline (EVP-6124) hydrochloride for Alzheimer's disease, dementia, and hepatic impairment, sponsored by industry entities including FORUM Pharmaceuticals and Mitsubishi Tanabe Pharma Corporation. While a clinical trial assessing single-dose pharmacokinetics in individuals with hepatic impairment was successfully completed, multiple clinical trials evaluating cognitive efficacy and long-term safety in Alzheimer's disease were ultimately terminated or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02246075	Withdrawn	Alzheimer''s Disease\|Dementia\|Cognition	FORUM Pharmaceuticals Inc\|Quintiles Inc.	2015-07	Phase 2
NCT02327182	Terminated	Alzheimer''s Disease	Mitsubishi Tanabe Pharma Corporation	2014-12	Phase 3
NCT02004392	Terminated	Alzheimer''s Disease\|Dementia	FORUM Pharmaceuticals Inc	2014-06	Phase 3
NCT01969123	Terminated	Alzheimer''s Disease\|Dementia	FORUM Pharmaceuticals Inc	2013-10	Phase 3
NCT01969136	Terminated	Alzheimer''s Disease\|Dementia	FORUM Pharmaceuticals Inc	2013-10	Phase 3
NCT01984736	Completed	Hepatic Impairment	FORUM Pharmaceuticals Inc\|PRA Health Sciences	2013-06	Phase 1

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

Check the Encenicline (EVP-6124) hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Encenicline hydrochloride functions as a selective partial agonist of the alpha-7 nicotinic acetylcholine receptor (α7 nAChR), binding to the receptor to potentiate acetylcholine-induced channel activation and enhance central cholinergic neurotransmission. This augmentation of synaptic signaling restores neuronal plasticity and network synchronized activity, providing the functional basis for improving memory performance and cognitive deficits in patients with Alzheimer's disease.

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>).