Esmolol Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple completed clinical trials have evaluated esmolol across acute care and surgical settings to maintain cardiovascular stability and control hyperinflammatory states. These include a Phase 2 trial sponsored by Sichuan Provincial People's Hospital that investigated esmolol's immunomodulatory effects on cytokine storm, catecholamine overproduction, and immune dysfunction in sepsis management. Additionally, a trial classified under phase Not Applicable, sponsored by Erasme University Hospital, evaluated the management of hemodynamic instability and nociceptive pain during cardiovascular surgery under general anesthesia.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06390748	Completed	Sepsis\|Lymphocyte Disorder T\|Immunologic Paralysis\|Catecholamine; Overproduction\|Beta-Blocker\|Cytokine Storm\|Sympathetic Nervous System Diseases	Lin Chen\|Sichuan Provincial People''s Hospital	2021-01-01	Phase 2
NCT04137991	Completed	Nociceptive Pain\|Goal-directed Therapy\|Hemodynamic Instability\|Nol-Index\|Remifentanil\|Cardiac Surgery\|Vascular Surgery\|General Anesthesia	Erasme University Hospital	2019-10-10	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Esmolol selectively binds to and antagonizes cardiac beta-1 adrenergic receptors, inhibiting catecholamine-stimulated adenylate cyclase activity and cyclic adenosine monophosphate production to suppress sinoatrial node automaticity and slow atrioventricular node conduction. This rapid blockade of sympathetic overdrive reduces myocardial oxygen demand and stabilizes cardiac rhythm, offering key clinical benefits in controlling hemodynamic instability, acute excessive sympathetic activation, and systemic stress during cardiovascular surgery and sepsis.

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>).