Esomeprazole sodium Clinical Trials

Size	Price	Qty
5mg	USD 170

Clinical Trials

Multiple Phase 1 clinical trials, encompassing both completed and actively recruiting protocols, are currently evaluating esomeprazole alone or co-administered with other therapeutic agents. Sponsored by industry leaders such as Incyte Corporation, Pfizer, Addpharma Inc., Eli Lilly and Company, and Bayer, these studies focus on gastroesophageal reflux disease, vasomotor symptoms associated with sex hormone-dependent disorders, and evaluations in healthy participants. Overall, these investigations evaluate drug-drug interactions, pharmacokinetics, pharmacodynamics, and safety parameters influenced by gastric acid modulation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06213818	Recruiting	Healthy Participants	Incyte Corporation	2024-03-14	Phase 1
NCT06275841	Recruiting	Healthy	Pfizer\|Arvinas Estrogen Receptor Inc.	2024-02-23	Phase 1
NCT05062876	Completed	Gastroesophageal Reflux Disease	Addpharma Inc.	2021-11-01	Phase 1
NCT06181084	Completed	Healthy	Eli Lilly and Company\|Loxo Oncology Inc.	2021-10-11	Phase 1
NCT05061563	Completed	Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men\|Hot Flashes	Bayer	2021-09-30	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Esomeprazole sodium selectively binds and inhibits the H+/K+-ATPase enzyme system in gastric parietal cells, blocking the final catalytic step in hydrogen ion secretion into the gastric lumen. This targeted enzyme inhibition reduces overall gastric acidity, providing therapeutic relief in gastroesophageal reflux disease and establishing controlled gastric pH environments relevant to clinical pharmacokinetics studies.

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>).