Scopolamine HBr trihydrate Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials spanning Phase 1, Phase 2, and Phase 4 are investigating the pharmacokinetic profiles and therapeutic applications of scopolamine for conditions including post-operative nausea and vomiting, motion sickness, major depressive disorder, and post-operative pain. Supported by academic medical centers such as the Milton S. Hershey Medical Center, Dartmouth-Hitchcock Medical Center, and the University of California, Los Angeles, these research efforts display varying recruitment statuses, including actively recruiting studies on novel delivery formulations, completed analgesia evaluations, terminated tolerability studies, and trials of unknown status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05759481	Recruiting	Post-operative Nausea and Vomiting	Milton S. Hershey Medical Center	2024-02-01	Phase 2
NCT04999449	Recruiting	Scopolamine\|Motion Sickness	Dartmouth-Hitchcock Medical Center	2022-01-24	Phase 1
NCT04314713	Terminated	Scopolamine Causing Adverse Effects in Therapeutic Use	Battelle Memorial Institute	2020-06-02	Phase 1
NCT03874130	Unknown status	Major Depressive Disorder (MDD)	Repurposed Therapeutics Inc.	2018-08-01	Phase 1
NCT03294109	Completed	Pain Postoperative\|Analgesics Opioid\|Analgesics Non-Narcotic\|Physiological Effects of Drugs\|Peripheral Nervous System Agents\|Patient Satisfaction\|Return to Work\|Activity Sexual	University of California Los Angeles	2018-01-01	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Scopolamine HBr trihydrate functions as a potent competitive antagonist of muscarinic acetylcholine receptors with an IC50 of 55.3 nM, thereby blocking endogenous acetylcholine binding and inhibiting downstream G-protein-coupled signaling pathways. This blockade suppresses cholinergic neurotransmission within the central and peripheral nervous systems, mitigating vestibular emetic signaling and parasympathetic tone to alleviate motion sickness and post-operative nausea and vomiting.

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>).