Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate Mefloquine HCl for diverse infectious and neurological indications. Key areas of investigation include Plasmodium falciparum and Plasmodium vivax malaria—focusing on drug resistance, transmission dynamics, and prophylaxis in pregnant or HIV-positive cohorts—as well as schistosomiasis, progressive multifocal leukoencephalopathy, and central nervous system malignancies such as glioblastoma and gliosarcoma. Sponsored by academic centers, government agencies like the CDC, and industry entities including Biogen, these evaluations encompass completed combination therapy studies as well as terminated and withdrawn trials.

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
NCT03893097 Completed
Schistosoma Haematobium|Schistosoma Mansoni
Institute of Tropical Medicine Belgium|Institut de Recherche en Santé de Surveillance Épidémiologique et de Formation (IRESSEF)
 2019-10-14 Phase 3
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
NCT02895568 Completed
Plasmodium Falciparum
University of Oxford|Worldwide Antimalarial Resistance Network|Mahidol University
 2016-09-16 --
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
NCT02524444 Completed
Malaria in Pregnant HIV + Patients
ORIYOMI OMOTOYOSI AKINYOTU|University of Ibadan
 2015-09 Phase 1
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
NCT01082718 Withdrawn
Malaria|Pregnancy
Centers for Disease Control and Prevention
 2010-03 Phase 2|Phase 3
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 HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mefloquine HCl acts as a blood schizonticide by disrupting the biopolymerization of toxic free heme into inert hemozoin within intraerythrocytic parasites, triggering an accumulation of cytotoxic heme complexes that cause parasite membrane disruption and cell death. This targeted parasiticidal action accounts for its therapeutic relevance in clinical trials directed against Plasmodium falciparum malaria and parasitic schistosomiasis infections.

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>).

Jump to

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