Mefloquine

also known as mefloquine hydrochloride · Eloquine

Developed for: malaria · Plasmodium falciparum malaria · cognitive impairment with or without cerebellar ataxia · gliosarcoma · progressive multifocal leukoencephalopathy · respiratory failure · Schistosoma mansoni infectious disease · urinary schistosomiasis
+2 more
· viral pneumonia · COVID-19
Investigated by: Albert Schweitzer Hospital · Centers for Disease Control and Prevention · Armed Forces Research Institute of Medical Sciences, Thailand · Institute of Tropical Medicine, Belgium · London School of Hygiene and Tropical Medicine · Mepha Ltd.
+51 more
· Pfizer · Research Institute for Development · U.S. Army Medical Research and Development Command · University of Oxford · Walter Reed Army Institute of Research (WRAIR) · Barcelona Centre for International Health Research · Biogen · Burnasyan Federal Medical Biophysical Center · Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland · Centre Mère et Enfant de la Fondation Chantal Biya · Elan Pharmaceuticals · Faculté des Sciences de la Santé, Bénin · Global Emerging Infections Surveillance and Response System · Hospital Clinic of Barcelona · Ifakara Health Institute · Institut de Recherche en Santé, de Surveillance Épidémiologique et de Formation (IRESSEF) · Institut des Sciences Biomédicales Appliquées, Bénin · Institute of Tropical Medicine, University of Tuebingen · Kenya Medical Research Institute · Kilimanjaro Christian Medical Centre, Tanzania · M.D. Anderson Cancer Center · Malaria Research and Training Center, Bamako, Mali · Malaria in Pregnancy Consortium · Manhiça Health Research Centre · Medical Research Council Unit, The Gambia · Medicines for Malaria Venture · Ministry of Foreign Affairs, France · Ministry of Health, Brazil · National Cancer Institute (NCI) · National Center for Parasitology, Entomology, and Malaria Control (CNM) · National Institute for Medical Research, Tanzania · National Institute of Allergy and Infectious Diseases (NIAID) · National Institute of Health of Peru · National Malaria Control Program, Benin · Naval Medical Research Unit-2 (NAMRU-2) · Oswaldo Cruz Foundation · Pan American Health Organization · Papua New Guinea Institute of Medical Research · Radboud University Medical Center · SmithKline Beecham · Swiss Tropical & Public Health Institute · Theranexus · U.S. Naval Medical Research Unit No.6 (NAMRU-6) · University of Cape Town · University of Copenhagen · University of Ilorin Teaching Hospital · University of Sao Paulo · Université d'Abomey-Calavi · Vienna School of Clinical Research (VSCR), Austria. · Wellcome Trust · ZonMw: The Netherlands Organisation for Health Research and Development

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansion	US (FDA)	LARIAM	—	1992-11-23	fda.gov ↗
Approved	US (FDA)	LARIAM	—	1989-05-02	fda.gov ↗

Trials 29

today

US approved 1989

NCT04347031 · Ph 2/3 NCT03893097 · Ph 3 NCT03726593 · Ph 4 NCT03698695 · Ph 1 NCT02612545 · Ph 1 NCT02324738 · Ph 4 NCT02084602 · Ph 4 NCT02052323 · Ph 4 NCT01615822 · Ph 1 NCT01422954 · not/applicable NCT01319448 · Ph 1/2 NCT01430351 · Ph 1 NCT01082731 · Ph 4 NCT01144702 · Ph 2/3 NCT01132248 · Ph 2 NCT01054248 · Ph 3 NCT00811421 · not/applicable NCT00746941 · Ph 1/2 NCT00761020 · not/applicable NCT00978172 · Ph 4 NCT00367653 · Ph 3 NCT00373048 · not/applicable NCT00243737 · Ph 2 NCT00274235 · Ph 3 NCT00127998 · not/applicable NCT00158574 · Ph 2/3 NCT00082576 · Ph 2/3 NCT00322907 · Ph 2 NCT02488902 · Ph 2

198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 14 trials
Phase 1	NCT03698695	Sep 2018 → Oct 2019	Alzheimer disease, cognitive impairment with or without cerebellar ataxia	Theranexus	Completed	No outcome recorded
Phase 1	NCT02612545	Nov 2015 → Oct 2018	Plasmodium falciparum malaria	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT01615822	Aug 2012 → Apr 2013	malaria	Medicines for Malaria Venture	Terminated	No outcome recorded
Phase 1	NCT01430351	Sep 2011 → Feb 2025	gliosarcoma	M.D. Anderson Cancer Center	Terminated	No outcome recorded Stop: Enrollment
Phase 1/22 trials · 1 missed
Phase 1/2	NCT01319448	Sep 2011 → Apr 2013	malaria, sickle cell disease	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 1/2	NCT00746941	Jan 2009 → Nov 2010	progressive multifocal leukoencephalopathy	Biogen	Terminated	Missed primary
Phase 24 trials
Phase 2	NCT01132248	May 2010 → Dec 2012	urinary schistosomiasis	Albert Schweitzer Hospital	Completed	No outcome recorded
Phase 2	NCT00243737	Oct 2005 → Apr 2006	malaria	Albert Schweitzer Hospital	Completed	No outcome recorded
Phase 2	NCT00322907	Apr 2000 → Jan 2003	malaria	Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland	Terminated	No outcome recorded
Phase 2	NCT02488902	Aug → Sep 1998	malaria	U.S. Army Medical Research and Development Command	Completed	No outcome recorded
Phase 2/34 trials · 2 met primary
Phase 2/3	NCT04347031	Apr → Nov 2020	respiratory failure, viral pneumonia	Burnasyan Federal Medical Biophysical Center	Completed	No outcome recorded
Phase 2/3	NCT01144702	Nov 2010 → Apr 2013	Plasmodium falciparum malaria	Oswaldo Cruz Foundation	Completed	No outcome recorded
Phase 2/3	NCT00158574	Jan 2005 → Apr 2008	malaria	London School of Hygiene and Tropical Medicine	Completed	Met primary
Phase 2/3	NCT00082576	Jun 2004 → May 2006	Plasmodium falciparum malaria	Pfizer	Completed	Met primary
Phase 34 trials · 2 met primary
Phase 3	NCT03893097	Oct 2019 → Mar 2021	Schistosoma mansoni infectious disease	Institute of Tropical Medicine, Belgium	Completed	Mixed
Phase 3	NCT01054248	Feb 2010 → Sep 2016	malaria	University of Oxford	Completed	No outcome recorded
Phase 3	NCT00367653	Nov 2006 → Sep 2007	Plasmodium falciparum malaria	Pfizer	Completed	Met primary
Phase 3	NCT00274235	Jul 2005 → Mar 2008	malaria	Research Institute for Development	Completed	Met primary
Phase 46 trials
Phase 4	NCT03726593	Oct 2018 → Aug 2022	Plasmodium falciparum malaria	Armed Forces Research Institute of Medical Sciences, Thailand	Unknown	No outcome recorded
Phase 4	NCT02324738	Jan → May 2015	—	University of Oxford	Completed	No outcome recorded
Phase 4	NCT02084602	Jun 2014 → Nov 2015	Plasmodium falciparum malaria	National Institute of Health of Peru	Completed	No outcome recorded
Phase 4	NCT02052323	Oct 2013 → Oct 2015	Plasmodium falciparum malaria	Armed Forces Research Institute of Medical Sciences, Thailand	Completed	No outcome recorded
Phase 4	NCT01082731	Nov 2010 → Jan 2012	malaria	Centers for Disease Control and Prevention	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT00978172	Dec 2007 → Mar 2009	malaria	Mepha Ltd.	Completed	No outcome recorded
Phase not applicable5 trials · 1 missed
—	NCT01422954	Jan → Dec 2012	Plasmodium falciparum malaria	Radboud University Medical Center	Completed	No outcome recorded
—	NCT00811421	Sep 2009 → Dec 2012	HIV infectious disease, malaria, pregnancy disorder	Hospital Clinic of Barcelona	Completed	Missed primary
—	NCT00761020	Sep 2008 → Apr 2009	malaria	U.S. Army Medical Research and Development Command	Completed	No outcome recorded
—	NCT00373048	Oct 2005 → Dec 2007	HIV infectious disease	Institute of Tropical Medicine, Belgium	Completed	No outcome recorded
—	NCT00127998	Jul 2005 → ?	malaria	Centers for Disease Control and Prevention	Completed	No outcome recorded
Comparator or background therapy23 trials
Phase 1	NCT02524444 Comparator	Sep 2015 → Aug 2016	—	ORIYOMI OMOTOYOSI AKINYOTU	Completed	No outcome recorded
Phase 2	NCT02488980 Comparator	May → Oct 2000	Plasmodium falciparum malaria	U.S. Army Medical Research and Development Command	Completed	No outcome recorded
Phase 2/3	NCT04847661 Comparator	Mar 2021 → Jun 2022	COVID-19	Helwan University	Completed	No outcome recorded
Phase 2/3	NCT02453308 Comparator	Aug 2015 → Mar 2018	Plasmodium falciparum malaria	University of Oxford	Completed	No outcome recorded
Phase 2/3	NCT00936767 Comparator	Oct 2010	Plasmodium falciparum malaria	University of Oxford	Withdrawn	No outcome recorded
Phase 3	NCT03939104 Comparator	Jun 2021 → Jan 2023	Plasmodium falciparum malaria	University of Oxford	Completed	No outcome recorded
Phase 3	NCT03923725 Comparator	Sep 2020 → Mar 2024	Plasmodium falciparum malaria	University of Oxford	Completed	No outcome recorded
Phase 3	NCT03452475 Comparator	Mar 2018 → Jun 2019	Plasmodium falciparum malaria	University of Oxford	Completed	No outcome recorded
Phase 3	NCT01939886 Comparator	Apr → Nov 2013	malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
Phase 3	NCT02974348 Comparator	Jan → May 2013	Plasmodium falciparum malaria	University of Bamenda	Completed	No outcome recorded
Phase 3	NCT01708876 Comparator	Oct 2012 → Dec 2014	—	Menzies School of Health Research	Completed	No outcome recorded
Phase 3	NCT00970879 Comparator	Dec 2009 → Jul 2012	HIV infectious disease, malaria	Research Institute for Development	Completed	No outcome recorded
Phase 3	NCT00403260 Comparator	Jan 2007 → Oct 2008	Plasmodium falciparum malaria	Medicines for Malaria Venture	Completed	Met primary
Phase 3	NCT00373607 Comparator	Jul 2003 → Jul 2005	malaria	Institute of Tropical Medicine, Belgium	Completed	No outcome recorded
Phase 4	NCT02653898 Comparator	Jan → Aug 2016	malaria	Armed Forces Research Institute of Medical Sciences, Thailand	Unknown	No outcome recorded
Phase 4	NCT01976780 Comparator	Jun 2013 → Dec 2014	Plasmodium falciparum malaria	Global Emerging Infections Surveillance and Response System	Completed	No outcome recorded
Phase 4	NCT00902811 Comparator	Dec 2008 → Oct 2009	Plasmodium falciparum malaria	Medecins Sans Frontieres, Netherlands	Unknown	No outcome recorded
Phase 4	NCT00444106 Comparator	May 2007 → Nov 2008	Plasmodium falciparum malaria	Novartis	Completed	Met primary
—	NCT03813108 Background	Apr 2019 → Feb 2021	Plasmodium falciparum malaria	Radboud University Medical Center	Terminated	No outcome recorded Stop: Enrollment
—	NCT01640587 Comparator	Nov 2013 → Mar 2017	Plasmodium falciparum malaria	University of Oxford	Terminated	No outcome recorded
—	NCT00499876 Comparator	Oct 2007 → Oct 2008	HIV infectious disease, malaria	London School of Hygiene and Tropical Medicine	Completed	No outcome recorded
—	NCT01659281 Comparator	Sep 2007 → May 2008	Plasmodium falciparum malaria	Armed Forces Research Institute of Medical Sciences, Thailand	Completed	No outcome recorded
—	NCT00493363 Comparator	Jun 2007 → Dec 2009	Plasmodium falciparum malaria	University of Oxford	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 6

Date	Issuer	Release
2020-11-04	Theranexus	Results PRESENTATION OF THE RESULTS OF THE PHASE IB CLINICAL STUDY OF THN201 FOR ALZHEIMER'S DISEASE AT THE CLINICAL TRIALS ON ALZHEIMER'S DISEASE CONFERENCE (CTAD) actusnews.com ↗ In January 2020, the results of the Phase Ib study revealed an extension of the pharmacological profile of the drug candidate THN201 compared to donepezil monotherapy.
2020-09-09	Theranexus	Results THERANEXUS PRESENTS ITS LATEST SCIENTIFIC NEWS actusnews.com ↗ The article reports on research using mouse models that once again reveals how mefloquine potentiates the impact of donepezil on the activity of the brain structures
2019-09-03	Theranexus	Results THERANEXUS ANNOUNCES THE PUBLICATION OF TWO SCIENTIFIC PAPERS AND A PRESENTATION AT THE EUROPEAN PAIN CONGRESS (EFIC) TO BE HELD ON 3-7 SEPTEMBER IN VALENCIA, SPAIN actusnews.com ↗ Finally, Theranexus will give a presentation during the upcoming European Pain Federation conference (EFIC) on the mechanism of action of THN101, its drug candidate for treating neuropathic pain.
2019-03-26	Theranexus	Results THERANEXUS TO PRESENT NEW SCIENTIFIC DATA ON DRUG CANDIDATE THN201 AT AD/PD 2019, THE 14TH CONFERENCE ON ALZHEIMER'S AND PARKINSON'S DISEASES LISBON, 26-31 MARCH 2019 actusnews.com ↗ The results obtained from these studies, conducted using state -of-the-art neuroscience technologies, have for the first time shown how glial cells can be used to enhance the procognitive activity of donepezil with mefloquine in preclinical dementia models.
2018-09-26	Theranexus	Regulatory THERANEXUS OBTAINS THE AUTHORIZATION TO START A PHASE Ib CLINICAL TRIAL WITH ITS DRUG CANDIDATE THN201 IN NEUROCOGNITIVE DISORDERS DUE TO ALZHEIMER'S DISEASE actusnews.com ↗ Theranexus, a biopharmaceutical company innovating in the treatment of neurological diseases and pioneer in the development of drug candidates modulating the interaction between neurons and glial cells, announces today it received the approval from French regulatory authorities to start a Phase Ib clinical trial with its drug candidate THN201.
2018-03-21	Theranexus	Results THERANEXUS ANNOUNCES A SUCCESSFUL CLINICAL PHARMACOKINETIC STUDY AS PART OF THE DEVELOPMENT OF ITS DRUG CANDIDATES THN201 AND THN101 actusnews.com ↗

All press releases naming this drug 6 releases

Date	Issuer	Release
2020-11-04	Theranexus	PRESENTATION OF THE RESULTS OF THE PHASE IB CLINICAL STUDY OF THN201 FOR ALZHEIMER'S DISEASE AT THE CLINICAL TRIALS ON ALZHEIMER'S DISEASE CONFERENCE (CTAD) actusnews.com ↗
2020-09-09	Theranexus	THERANEXUS PRESENTS ITS LATEST SCIENTIFIC NEWS actusnews.com ↗
2019-09-03	Theranexus	THERANEXUS ANNOUNCES THE PUBLICATION OF TWO SCIENTIFIC PAPERS AND A PRESENTATION AT THE EUROPEAN PAIN CONGRESS (EFIC) TO BE HELD ON 3-7 SEPTEMBER IN VALENCIA, SPAIN actusnews.com ↗
2019-03-26	Theranexus	THERANEXUS TO PRESENT NEW SCIENTIFIC DATA ON DRUG CANDIDATE THN201 AT AD/PD 2019, THE 14TH CONFERENCE ON ALZHEIMER'S AND PARKINSON'S DISEASES LISBON, 26-31 MARCH 2019 actusnews.com ↗
2018-09-26	Theranexus	THERANEXUS OBTAINS THE AUTHORIZATION TO START A PHASE Ib CLINICAL TRIAL WITH ITS DRUG CANDIDATE THN201 IN NEUROCOGNITIVE DISORDERS DUE TO ALZHEIMER'S DISEASE actusnews.com ↗
2018-03-21	Theranexus	THERANEXUS ANNOUNCES A SUCCESSFUL CLINICAL PHARMACOKINETIC STUDY AS PART OF THE DEVELOPMENT OF ITS DRUG CANDIDATES THN201 AND THN101 actusnews.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 53 sources stand behind the page.

Field	Value	Cited text
Known as	mefloquine	“Artesunate-mefloquine fixed dose combination (artesunate 25mg/mefloquine hydrochloride 55mg, or artesunate 100mg/mefloquine hydrochloride 220mg), according to age-group.” NCT00902811 ↗ 51 “Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes while taking mefloquine prophylaxis.” NCT03813108 ↗ “THN201: Donepezil 5mg capsule and Mefloquine 10mg capsule once daily for 15 days” NCT03698695 ↗ “Mefloquine 250 mg tablet, single dose” NCT01615822 ↗ “Mefloquine hydrochloride for 3 days” NCT02453308 ↗ NCT00127998 ↗ NCT03726593 ↗ NCT00493363 ↗ NCT01640587 ↗ NCT04847661 ↗ NCT02612545 ↗ Show 41 more sources
Known as	Eloquine	“One tablet of mefloquine contains 250 mg mefloquine (Eloquine® (Medochemie Ltd., Cyprus)” NCT01640587 ↗
Known as	mefloquine hydrochloride	“Adults with fever, a positive peripheral blood smear, and a positive rapid diagnostic test for Plasmodium falciparum were randomised in both studies to either azithromycin (AZ)...” PMID 25425434 ↗ Nov 2014 1 “Mefloquine hydrochloride will be given in a dose of 1100-1650 mg, according to body weight (BW), splitted into two to three doses.” NCT04847661 ↗
Route	Oral	“Oral administration of mefloquine can induce vomiting in children suffering from clinical malaria.” NCT00158574 ↗