Eprinomectin Clinical Trials

Size	Price	Qty
100mg	USD 147

Clinical Trials

Multiple completed clinical trials, encompassing Phase 4 and unassigned phase studies, have evaluated cognitive performance during sleep deprivation as well as therapeutic strategies for psychiatric conditions including schizophrenia, schizoaffective disorder, and psychotic disorders. Sponsored by medical and academic institutions such as Herlev Hospital, the TRYG Foundation, the Danish Medical Association, and the Central Institute of Mental Health Mannheim, these investigations focused on sleep loss and psychiatric health.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01623674	Completed	Effect of Sleep Deprivation	Herlev Hospital\|TRYG Foundation\|Danish Medical Association	2011-12	--
NCT00224302	Completed	Psychotic Disorders	Central Institute of Mental Health Mannheim	2005-08	Phase 4
NCT00224315	Completed	Schizophrenia Schizoaffective Disorder	Central Institute of Mental Health Mannheim	2003-11	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Eprinomectin selectively binds to glutamate-gated chloride channels in invertebrate nerve and muscle cells, increasing membrane permeability to chloride ions and suppressing downstream neuromuscular neurotransmission. This hyperpolarization leads to cellular paralysis and parasite clearance, providing a mechanistic link to clinical trials investigating neurophysiological responses in conditions such as sleep deprivation, schizophrenia, and psychotic disorders.

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>).