pomaglumetad (LY404039) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 457

Clinical Trials

Multiple clinical trials ranging from Phase I to Phase III have evaluated pomaglumetad (LY404039) for psychiatric and neurological conditions—including schizophrenia, clinical high risk for psychosis, post-traumatic stress disorder, methamphetamine use disorder, and hepatic insufficiency—alongside pharmacokinetic, biomarker, and glutamate reduction assessments in healthy volunteers. Sponsored by pharmaceutical companies and academic institutions such as Eli Lilly and UCLA, these evaluations encompass completed, terminated, and withdrawn protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03106571	TERMINATED	Methamphetamine Use Disorder	University of California, Los Angeles	2017-08-01	PHASE1
NCT03321617	COMPLETED	Clinical High Risk for Psychosis	New York State Psychiatric Institute	2018-04-17	PHASE1
NCT02919774	COMPLETED	Healthy Controls	New York State Psychiatric Institute	2016-10	PHASE1
NCT02234687	TERMINATED	Post-traumatic Stress Disorder	NYU Langone Health	2014-09	PHASE1
NCT01487083	TERMINATED	Schizophrenia	Eli Lilly and Company	2011-12	PHASE3
NCT01659177	WITHDRAWN	Healthy Participants	Denovo Biopharma LLC	2012-08	PHASE1
NCT01659177	Withdrawn	Healthy Participants	Denovo Biopharma LLC	2012-08	Phase 1
NCT01637142	COMPLETED	Healthy Participants	Denovo Biopharma LLC	2012-07	PHASE1
NCT01637142	Completed	Healthy Participants	Denovo Biopharma LLC	2012-07	Phase 1
NCT01609218	Completed	Healthy Volunteer Study	Denovo Biopharma LLC	2012-06	Phase 1
NCT01475136	Completed	Hepatic Insufficiency	Denovo Biopharma LLC	2011-11	Phase 1
NCT01440478	COMPLETED	Healthy Subjects	Eli Lilly and Company	2011-09	PHASE1

(data from https://clinicaltrials.gov, updated on 2020-09-01)

Check the pomaglumetad (LY404039) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pomaglumetad (LY404039) selectively binds to and activates metabotropic glutamate group II subtypes mGlu2 and mGlu3 receptors, thereby inhibiting forskolin-stimulated cAMP accumulation and modulating presynaptic glutamate release. This attenuation of excitatory neurotransmission normalizes dysregulated glutamatergic signaling, providing therapeutic potential in central nervous system disorders such as schizophrenia 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>).