Neostigmine Bromide Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials evaluate neostigmine bromide across early phase, Phase 1, Phase 4, and unassigned protocols for perioperative and postoperative indications. Sponsored by academic institutions and industry partners, these studies examine neuromuscular blockade reversal, postoperative pain, postoperative urinary retention, and surgical anesthesia management. Current recruitment statuses range from completed studies and actively recruiting trials to protocols that are not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06136585	Not yet recruiting	Neuromuscular Blocks	The Cleveland Clinic\|Merck Sharp & Dohme LLC	2024-05-15	Not Applicable
NCT05943613	Not yet recruiting	Postoperative Pain	Assiut University	2023-12-01	Phase 1
NCT05794503	Recruiting	Urinary Retention Postoperative\|Laparoscopic Cholecystectomy\|Neuromuscular Blockade\|Sugammadex\|Neostigmine\|Neuromuscular Blocking Agents\|Physiological Effects of Drugs	University of Texas Southwestern Medical Center	2023-09-11	Early Phase 1
NCT04570150	Completed	Anesthesia	University of California San Diego	2021-01-04	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Neostigmine bromide reversibly binds to the anionic and active sites of acetylcholinesterase, inhibiting enzymatic degradation of acetylcholine and leading to elevated neurotransmitter accumulation at the postsynaptic membrane. This sustained signaling enhances cholinergic transmission across neuromuscular junctions and parasympathetic effectors, facilitating muscle contraction restoration required for the reversal of neuromuscular blockade and postoperative recovery.

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>).