Clinical Trials

Numerous clinical trials spanning early through late phases evaluate meclizine across diverse indications, primarily targeting vestibular and emetic conditions—such as vertigo, motion sickness, and postoperative nausea—alongside hepatocellular carcinoma, smoking cessation, and healthy volunteer physiology. Sponsored by academic, military, and commercial entities including Vanderbilt University, the Israel Defense Forces Medical Corps, and Karuna Therapeutics, these protocols encompass completed, active, upcoming, and unknown recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07681076 NOT_YET_RECRUITING
Healthy Volunteers
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
 2026-08-03 PHASE4
NCT05852730 RECRUITING
Motion Sickness, Space; Motion Simulation; Parabolic Flight
Repurposed Therapeutics, Inc.
 2021-08-10 PHASE2
NCT03253289 COMPLETED
Carcinoma, Hepatocellular
Tannaz Armaghnay
 2017-10-13 PHASE1
NCT04482985 UNKNOWN
Seasickness; Meclizine
Medical Corps, Israel Defense Force
 2020-09-01 PHASE4
NCT04564144 UNKNOWN
Emesis
Mansoura University
 2020-06-01 PHASE1; PHASE2
NCT04482985 Unknown status
Seasickness|Meclizine
Medical Corps Israel Defense Force
 2020-09-01 Phase 4
NCT04564144 Unknown status
Emesis
Mansoura University
 2020-06-01 Phase 1|Phase 2
NCT02625181 COMPLETED
Postoperative Nausea and Vomiting
Vanderbilt University
 2016-07
NCT02112578 COMPLETED
Vertigo, Peripheral
Apsen Farmaceutica S.A.
 2016-11-01 PHASE3
NCT01443858 COMPLETED
Smoking Cessation
Duke University
 2011-08 PHASE2
NCT01537471 COMPLETED
Healthy
Duke University
 2012-01 PHASE1
NCT00641797 COMPLETED
Benign Paroxysmal Positional Vertigo
Lehigh Valley Hospital
 2006-11

(data from https://clinicaltrials.gov, updated on 2026-07-02)

Check the Meclizine 2HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Meclizine acts as a histamine H1 receptor antagonist and anticholinergic agent, selectively binding to central H1 and muscarinic receptors to block histaminergic and cholinergic neurotransmission while depressing labyrinth excitability and medullary chemoreceptor trigger zone activity. This reduction in central vestibular sensitivity mitigates motion-induced emetic pathways, thereby providing therapeutic efficacy against seasickness, vertigo, and postoperative nausea and vomiting evaluated in clinical trials.

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>).

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Note: Technical data last updated: Sep 1, 2026.