Esmolol HCl Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Several completed clinical trials, including Phase 2 and unclassified phase studies, have evaluated esmolol across cardiovascular and critical care settings. Sponsored by academic and hospital entities such as Sichuan Provincial People's Hospital and Erasme University Hospital, these trials investigated conditions including sepsis, cytokine storm, immunologic paralysis, and perioperative hemodynamic instability during surgery. Together, this research assesses both the intraoperative cardiovascular stabilization and autonomic immunomodulatory responses conferred by esmolol.

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 HCl 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 beta-1 adrenergic receptors, inhibiting catecholamine-stimulated intracellular cyclic adenosine monophosphate production and downstream protein kinase A signaling to decrease cardiac ionotropic and chronotropic activity. This attenuation of sympathetic hyperactivation lowers heart rate and myocardial oxygen demand, mitigating hemodynamic instability during cardiovascular surgery and controlling systemic hyperinflammatory states such as sepsis and cytokine storm.

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>).