Atracurium Besylate Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Several clinical trials evaluate atracurium besylate for applications in anesthesia, surgical procedures, and patient recovery monitoring across Phase 3 and non-phased research projects. Sponsored by academic and healthcare centers, these studies address conditions including prolonged neuromuscular block, neuromuscular residual curarization, meningioma, and posterior spine surgery. Ranging from recruiting to completed recruitment statuses, these trials reflect ongoing efforts to optimize neuromuscular monitoring and patient safety during surgical operations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05657756	Recruiting	Neuromuscular Block Prolonged	Al Safwa University College	2023-06-01	Not Applicable
NCT05231525	Completed	Neuromuscular Residual Curarization	Poitiers University Hospital	2022-03-09	Not Applicable
NCT03558516	Completed	Meningioma	Mahidol University	2018-08-01	Phase 3
NCT03319563	Completed	Posterior Spine Surgery	Mansoura University	2017-04-11	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Atracurium besylate functions as a competitive antagonist at neuromuscular nicotinic acetylcholine receptors, preventing endogenous acetylcholine from binding to motor end-plate receptors. This competitive receptor blockade prevents end-plate depolarization and channel opening, which halts muscle excitation-contraction coupling to induce reversible skeletal muscle relaxation required during spine and craniotomy surgeries.

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>).