Clinical Trials

Numerous clinical trials evaluate mefloquine across Phase 1 through Phase 4 studies, focusing primarily on Plasmodium falciparum, Plasmodium vivax, drug-resistant malaria, and malaria in pregnancy, alongside exploratory trials for COVID-19, progressive multifocal leukoencephalopathy, and glioblastoma. Sponsored by academic, governmental, and industrial entities—including the London School of Hygiene and Tropical Medicine, the U.S. Army Medical Research and Development Command, Biogen, and M.D. Anderson Cancer Center—these investigations reflect varying recruitment statuses. Portfolio statuses range from completed studies evaluating therapeutic efficacy and transmission to terminated trials in neuro-oncology and viral leukoencephalopathy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01430351 TERMINATED
Glioblastoma; Gliosarcoma; Supratentorial Glioblastoma
M.D. Anderson Cancer Center
 2011-09-14 PHASE1
NCT03923725 COMPLETED
Plasmodium Falciparum Malaria (Uncomplicated)
University of Oxford
 2020-09-01 PHASE3
NCT03939104 COMPLETED
Plasmodium Falciparum Malaria (Uncomplicated)
University of Oxford
 2021-06-30 PHASE3
NCT03726593 UNKNOWN
Plasmodium Falciparum Malaria (Drug Resistant)
Armed Forces Research Institute of Medical Sciences, Thailand
 2018-10-04 PHASE4
NCT04847661 COMPLETED
Covid19
Helwan University
 2021-03-28 PHASE2; PHASE3
NCT03893097 COMPLETED
Schistosoma Haematobium; Schistosoma Mansoni
Institute of Tropical Medicine, Belgium
 2019-10-14 PHASE3
NCT04347031 COMPLETED
Pneumonia, Viral; Respiratory Failure
Burnasyan Federal Medical Biophysical Center
 2020-04-08 PHASE2; PHASE3
NCT03452475 COMPLETED
Plasmodium Falciparum
University of Oxford
 2018-03-07 PHASE3
NCT02612545 COMPLETED
Acute Falciparum Malaria
National Institute of Allergy and Infectious Diseases (NIAID)
 2015-11-20 PHASE1
NCT01640587 TERMINATED
P. Falciparum Malaria
University of Oxford
 2013-11
NCT01054248 COMPLETED
Malaria
University of Oxford
 2010-02-16 PHASE3
NCT02653898 UNKNOWN
Malaria; Parasitic Diseases
Armed Forces Research Institute of Medical Sciences, Thailand
 2016-01 PHASE4
NCT02524444 COMPLETED
Malaria in Pregnant HIV + Patients
ORIYOMI OMOTOYOSI AKINYOTU
 2015-09 PHASE1
NCT02084602 COMPLETED
Malaria, Falciparum
Instituto Nacional de Salud. Peru
 2014-06-18 PHASE4
NCT02052323 COMPLETED
Malaria
Armed Forces Research Institute of Medical Sciences, Thailand
 2013-10 PHASE4
NCT02324738 COMPLETED
Healthy
University of Oxford
 2015-01 PHASE4
NCT01708876 COMPLETED
Uncomplicated Plasmodium Knowlesi Malaria
Menzies School of Health Research
 2012-10 PHASE3
NCT01976780 COMPLETED
Malaria
Global Emerging Infections Surveillance and Response System
 2013-06 PHASE4
NCT01939886 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
 2013-04 PHASE3
NCT00852423 COMPLETED
Malaria in Pregnancy
Institute of Tropical Medicine, Belgium
 2010-06 PHASE3
NCT02974348 COMPLETED
Drug Resistant Malaria Due to Plasmodium Falciparum
University of Bamenda
 2013-01 PHASE3
NCT01319448 COMPLETED
Malaria; Sickle Cell Crisis
London School of Hygiene and Tropical Medicine
 2011-09 PHASE1; PHASE2
NCT01144702 COMPLETED
Falciparum Malaria
Oswaldo Cruz Foundation
 2010-11 PHASE2; PHASE3
NCT01615822 TERMINATED
Malaria
Medicines for Malaria Venture
 2012-08 PHASE1
NCT00811421 COMPLETED
Pregnancy; Malaria; HIV Infections
Hospital Clinic of Barcelona
 2009-09
NCT01422954 COMPLETED
Malaria; Plasmodium Falciparum
Radboud University Medical Center
 2012-01
NCT01132248 COMPLETED
Urinary Schistosomiasis
Albert Schweitzer Hospital
 2010-05 PHASE2
NCT00970879 COMPLETED
Malaria in Pregnancy; HIV Infections
Institut de Recherche pour le Developpement
 2009-12 PHASE3
NCT01107145 TERMINATED
Plasmodium Vivax Malaria
Centers for Disease Control and Prevention
 2011-02 PHASE4
NCT01082731 TERMINATED
Malaria
Centers for Disease Control and Prevention
 2010-11 PHASE4
NCT00746941 TERMINATED
Progressive Multifocal Leukoencephalopathy
Biogen
 2009-01 PHASE1; PHASE2
NCT00936767 WITHDRAWN
Uncomplicated Falciparum Malaria
University of Oxford
 2010-10 PHASE2; PHASE3
NCT01082718 WITHDRAWN
Malaria; Pregnancy
Centers for Disease Control and Prevention
 2010-03 PHASE2; PHASE3
NCT00493363 COMPLETED
Falciparum Malaria
University of Oxford
 2007-06
NCT00931697 COMPLETED
Healthy Subjects
Treague Ltd
 2009-06 PHASE1
NCT00701961 COMPLETED
Plasmodium Falciparum Malaria
Institute of Tropical Medicine, Belgium
 2008-10 PHASE2; PHASE3
NCT00761020 COMPLETED
Malaria
U.S. Army Medical Research and Development Command
 2008-09
NCT00444106 COMPLETED
Malaria; Falciparum
Novartis
 2007-05 PHASE4
NCT00403260 COMPLETED
Falciparum Malaria
Medicines for Malaria Venture
 2007-01 PHASE3
NCT00499876 COMPLETED
HIV Infections; Malaria
London School of Hygiene and Tropical Medicine
 2007-10
NCT01659281 COMPLETED
Plasmodium Falciparum Malaria
Armed Forces Research Institute of Medical Sciences, Thailand
 2007-09
NCT00158574 COMPLETED
Malaria
London School of Hygiene and Tropical Medicine
 2005-01 PHASE2; PHASE3
NCT00274235 COMPLETED
Malaria
Institut de Recherche pour le Developpement
 2005-07 PHASE3
NCT00373048 COMPLETED
HIV Infections
Institute of Tropical Medicine, Belgium
 2005-10
NCT00367653 COMPLETED
Malaria
Pfizer
 2006-11 PHASE3
NCT00386750 TERMINATED
Malaria; Falciparum
Novartis Pharmaceuticals
 2005-06 PHASE4
NCT00373607 COMPLETED
Malaria
Institute of Tropical Medicine, Belgium
 2003-07 PHASE3
NCT02488980 COMPLETED
Falciparum Parasitaemia
U.S. Army Medical Research and Development Command
 2000-05 PHASE2
NCT02488902 COMPLETED
Malaria
U.S. Army Medical Research and Development Command
 1998-08 PHASE2
NCT00322907 TERMINATED
Clinical Malaria
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
 2000-04 PHASE2
NCT00978172 COMPLETED
Malaria
Mepha Ltd.
 2007-12 PHASE4
NCT00243737 COMPLETED
Malaria
Albert Schweitzer Hospital
 2005-10 PHASE2
NCT00127998 COMPLETED
Malaria
Centers for Disease Control and Prevention
 2005-07
NCT00082576 COMPLETED
Malaria, Falciparum
Pfizer
 2004-06 PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2025-05-07)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mefloquine acts as a quinoline antimalarial agent that binds to and antagonizes KvQT1/minK potassium channels with an IC50 of approximately 1 μM, thereby disrupting transmembrane potassium ion flux and cellular homeostasis. This inhibition leads to impaired cellular ionic balance and targeted parasite clearance, underlying its therapeutic utility observed in clinical trials evaluating the treatment and prophylaxis of Plasmodium falciparum and Plasmodium vivax malaria.

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.