Escitalopram Oxalate Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Several clinical trials evaluate Escitalopram Oxalate across Phase 1, Phase 4, and unassigned study phases, sponsored by academic medical centers and clinical research institutions. These studies investigate major depressive disorder, anxiety disorders, opioid-induced respiratory depression, and neurocognitive responses in healthy volunteers. Recruitment status across these protocols ranges from completed studies to those that are not yet recruiting or have an unknown status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05730062	Not yet recruiting	Opioid Induced Respiratory Depression\|Depressive Disorder\|Anxiety Disorders	Leiden University Medical Center	2023-03-15	Phase 1
NCT05210140	Unknown status	Depressive Disorder Major	University of Belgrade\|Clinical Centre of Serbia\|Institute of Mental Health Serbia\|Military Medical Academy Belgrade Serbia	2020-07-16	--
NCT04239339	Completed	Healthy	Rigshospitalet Denmark\|University of Cambridge\|Lundbeck Foundation	2020-04-28	Phase 4
NCT03912974	Completed	Healthy	University Hospital Basel Switzerland	2019-07-04	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Escitalopram Oxalate selectively binds to the serotonin transporter with a Ki of 0.89 nM, blocking presynaptic serotonin reuptake and elevating extracellular serotonin levels within the synaptic cleft. This enhanced serotonergic neurotransmission modulates downstream neural circuitry, providing the therapeutic foundation for treating major depressive disorder and anxiety 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>).