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Drugs / Primaquine
last change Aug 2026 re-read 9 days ago

Primaquine

also known as primaquine phosphate · LD PQ · PQ base · Primaquine GPO · SLD-PQ

Small molecule

Developed for
Plasmodium vivax malaria · Plasmodium falciparum malaria · malaria · G6PD deficiency · pneumocystosis · COVID-19 · parasitemia
Investigated by
University of Oxford · London School of Hygiene and Tropical Medicine · Menzies School of Health Research · Mahidol Oxford Tropical Medicine Research Unit · Mahidol University · University of California, San Francisco
+117 more · Centers for Disease Control and Prevention · University of Melbourne · Arba Minch University · Medicines for Malaria Venture · National Centre for Parasitology, Entomology and Malaria Control, Cambodia · PATH · Papua New Guinea Institute of Medical Research · Radboud University Medical Center · Bill and Melinda Gates Foundation · Curtin University · HealthNet TPO · Indonesia University · Malaria Research and Training Center, Bamako, Mali · National Institute of Allergy and Infectious Diseases (NIAID) · Universitas Sumatera Utara · Uppsala University · Walter Reed Army Institute of Research (WRAIR) · World Health Organization · Addis Ababa University · Aga Khan University · Armed Forces Research Institute of Medical Sciences, Thailand · Centre national de recherche et de formation sur le paludisme · Ethiopian Public Health Institute · GlaxoSmithKline · International Centre for Diarrhoeal Disease Research, Bangladesh · Karolinska Institutet · L'université de Thiès · Muhimbili University of Health and Allied Sciences · National Malaria Control Program, Niger · Pan American Health Organization · Shoklo Malaria Research Unit · Syamsudin Abdillah,Ph.D, Pharm D · Tribhuvan University, Nepal · UNITAID · Wellcome Trust · Zanzibar Malaria Elimination Programme · Apt. Dian Yudianto; Dr. dr Erni J. Nelwan, Sp.PD, Ph.D; Apt.Hesty Utami Ramadaniati, M.Clin, Pharm, Ph.D · Armauer Hansen Research Institute, Ethiopia · Burnet Institute · Cayenne Hospital · Centro Nacional de Vigilancia Epidemiológica y control de enfermedades (CENAVECE), Mexico · Cheikh Anta Diop University, Senegal · Columbia University · Dinka Dugassa · Dr Cipto Mangunkusumo General Hospital · Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia · Ethiopian Health and Nutrition Research Institute · European and Developing Countries Clinical Trials Partnership (EDCTP) · Evandro Chagas National Institute of Infectious Disease · FHI 360 · Federal Minstry of Health of Ethiopia · Foundation for Scientific Research Suriname (SWOS) Paramaribo, Suriname · Fundação de Medicina Tropical Dr. Heitor Vieira Dourado · Gadjah Mada University · Glaxo Wellcome · Global Emerging Infections Surveillance and Response System · Heidelberg University · Ifakara Health Institute · Institut Pasteur · Institut Pasteur de Madagascar · Institut Pasteur du Cambodge · Institute Pasteur, Cambodia · Institute of Tropical Medicine, Belgium · Instituto de Diagnóstico y Referencia Epidemiológicos (InDRE), Mexico · International Centre of Insect Physiology and Ecology (ICIPE) · Jacobus Pharmaceutical · Jimma University · Jurisdicción Sanitaria VII, Chiapas, México · Kilimanjaro Clinical Research Institute · LILIA GONZALEZ CERON · Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit · Macfarlane Burnet Institute for Medical Research and Public Health Ltd · Malaria Consortium · Malaria Control Program, Directorate of Malaria Control, Pakistan · all 123 on the full record

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) PRIMAQUINE — 1952-01-23 fda.gov ↗

Trials 80 · started per year

today
US approved 1952
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 111 trials
Phase 1 NCT05938608 Mar 2024 → Mar 2025 — University of Oxford Withdrawn No outcome recorded
Phase 1 NCT02898779 May 2017 → Mar 2018 malaria University of Mississippi, Oxford Completed No outcome recorded
Phase 1 NCT02960568 Jan 2016 → Jul 2017 — Walter Reed Army Institute of Research (WRAIR) Completed No outcome recorded
Phase 1 NCT02568098 Oct 2015 → Dec 2016 — University of Oxford Completed No outcome recorded
Phase 1 NCT01668433 Jul 2013 → Oct 2014 G6PD deficiency University of Oxford Completed No outcome recorded
Phase 1 NCT01780753 Dec 2012 → Jul 2014 Plasmodium vivax malaria University of Oxford Completed No outcome recorded
Phase 1 NCT01525511 Jun → Sep 2012 — University of Oxford Completed No outcome recorded
Phase 1 NCT01552330 May → Oct 2012 — University of Oxford Completed No outcome recorded
Phase 1 NCT01500980 Dec 2011 → Jul 2012 Plasmodium falciparum malaria Seattle Children's Hospital Completed No outcome recorded
Phase 1 NCT02789566 Aug → Nov 2011 obesity disorder University of Oxford Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT02696954 Nov 2016 → Mar 2019 — University of Oxford Terminated No outcome recorded
Phase 1/2 NCT02535767 Aug 2015 → Jan 2016 malaria University of California, San Francisco Completed No outcome recorded
Phase 29 trials · 2 met primary
Phase 2 NCT05252845 Jan → Jun 2023 Plasmodium falciparum malaria University of Oxford Completed No outcome recorded
Phase 2 NCT05829187 Nov → Dec 2022 Plasmodium falciparum malaria Syamsudin Abdillah,Ph.D, Pharm D Completed No outcome recorded
Phase 2 NCT05550909 Oct → Dec 2022 Plasmodium falciparum malaria London School of Hygiene and Tropical Medicine Completed Mixed
Phase 2 NCT05081089 Oct → Dec 2021 Plasmodium falciparum malaria London School of Hygiene and Tropical Medicine Completed No outcome recorded
Phase 2 NCT06036030 Jan → Apr 2019 Plasmodium falciparum malaria, Plasmodium vivax malaria Syamsudin Abdillah,Ph.D, Pharm D Completed No outcome recorded
Phase 2 NCT02992119 Jun 2017 → Feb 2018 malaria University of Oxford Completed No outcome recorded
Phase 2 NCT02831023 Jul 2016 → Jan 2017 malaria University of California, San Francisco Completed Met primary
Phase 2 NCT01743820 Sep 2013 → Dec 2014 malaria University of California, San Francisco Completed Met primary
Phase 2 NCT00959517 Jul 2001 → Jun 2005 Plasmodium falciparum malaria London School of Hygiene and Tropical Medicine Completed No outcome recorded
Phase 2/36 trials
Phase 2/3 NCT07060404 Apr → Dec 2026 expected — Curtin University Not yet recruiting No outcome recorded
Phase 2/3 NCT05232227 Jan → Jun 2023 Plasmodium vivax malaria University of California, San Francisco Withdrawn No outcome recorded Stop: Business
Phase 2/3 NCT04349410 Apr → Sep 2020 COVID-19 The Camelot Foundation Completed No outcome recorded
Phase 2/3 NCT02654730 Dec 2015 → Sep 2016 malaria London School of Hygiene and Tropical Medicine Terminated No outcome recorded Stop: Enrollment
Phase 2/3 NCT02174900 Oct 2014 → Dec 2015 Plasmodium falciparum malaria London School of Hygiene and Tropical Medicine Completed No outcome recorded
Phase 2/3 NCT01935882 Sep 2013 → Jul 2015 Plasmodium falciparum malaria London School of Hygiene and Tropical Medicine Completed No outcome recorded
Phase 315 trials · 2 met primary · 3 missed
Phase 3 NCT07468526 Jun 2026 → Dec 2027 expected malaria Menzies School of Health Research Not yet recruiting No outcome recorded
Phase 3 NCT06923592 May 2025 → Apr 2027 expected Plasmodium falciparum malaria, Plasmodium vivax malaria London School of Hygiene and Tropical Medicine Recruiting No outcome recorded
Phase 3 NCT05690841 Oct 2024 → May 2027 expected Plasmodium vivax malaria University of California, San Francisco Recruiting No outcome recorded
Phase 3 NCT06148792 May 2024 → Mar 2027 expected Plasmodium vivax malaria Menzies School of Health Research Recruiting No outcome recorded
Phase 3 NCT04411836 Apr 2021 → Sep 2024 Plasmodium vivax malaria Menzies School of Health Research Completed Missed primary
Phase 3 NCT02216123 Apr 2015 → Nov 2016 Plasmodium vivax malaria GlaxoSmithKline Completed Missed primary
Phase 3 NCT02259426 Oct 2014 → Sep 2015 Plasmodium falciparum malaria London School of Hygiene and Tropical Medicine Completed No outcome recorded
Phase 3 NCT01838902 Aug 2013 → Feb 2015 malaria London School of Hygiene and Tropical Medicine Completed Met primary
Phase 3 NCT01640574 Feb 2012 → Jul 2015 Plasmodium vivax malaria University of Oxford Completed No outcome recorded
Phase 3 NCT01365598 Dec 2011 → Mar 2013 Plasmodium falciparum malaria London School of Hygiene and Tropical Medicine Completed No outcome recorded
Phase 422 trials · 3 met primary · 1 missed
Phase 4 NCT07357103 Mar 2026 → Mar 2029 expected pneumocystosis McGill University Health Centre/Research Institute of the McGill University Health Centre Not yet recruiting No outcome recorded
Phase 4 NCT06191458 Jul 2024 → Feb 2025 puerperal disorder University of Oxford Completed No outcome recorded
Phase 4 NCT04984759 Jul 2023 → Jun 2025 — University of Oxford Withdrawn No outcome recorded
Phase 4 NCT06044805 Dec 2022 → Mar 2023 Plasmodium vivax malaria Dinka Dugassa Completed No outcome recorded
Phase 4 NCT04079621 Oct 2021 → Mar 2024 Plasmodium falciparum malaria, Plasmodium vivax malaria Menzies School of Health Research Completed No outcome recorded
Phase 4 NCT04706130 Apr 2021 → Oct 2024 Plasmodium vivax malaria University of Maryland, Baltimore Completed Met primary
Phase 4 NCT03916003 Aug 2019 → May 2022 Plasmodium falciparum malaria, Plasmodium vivax malaria Menzies School of Health Research Completed Met primary
Phase 4 NCT03352843 Jun 2019 → Feb 2020 malaria Tropical Pesticides Research Institute, Tanzania Completed Met primary
Phase 4 NCT03337152 May → Aug 2018 G6PD deficiency, Plasmodium vivax malaria PATH Terminated No outcome recorded
Phase 4 NCT03241901 Jul → Dec 2017 Plasmodium falciparum malaria Muhimbili University of Health and Allied Sciences Completed Missed primary
Phase not applicable15 trials · 1 met primary · 2 missed
— NCT07281443 Sep 2024 → Dec 2026 expected Plasmodium falciparum malaria, parasitemia Research Institute for Development Active not recruiting No outcome recorded
— NCT05874271 Aug 2023 → Oct 2025 G6PD deficiency, Plasmodium vivax malaria Macfarlane Burnet Institute for Medical Research and Public Health Ltd Completed No outcome recorded
— NCT05879224 Aug 2023 → Nov 2025 G6PD deficiency, Plasmodium vivax malaria Menzies School of Health Research Completed No outcome recorded
— NCT05540470 Sep 2022 → Mar 2025 Plasmodium vivax malaria Cayenne Hospital Completed No outcome recorded
— NCT04864444 Jun 2021 → Dec 2022 Plasmodium falciparum malaria University of California, San Francisco Completed Missed primary
— NCT04228315 Nov 2019 → Jun 2021 Plasmodium vivax malaria Armed Forces Research Institute of Medical Sciences, Thailand Unknown No outcome recorded
— NCT06392152 Jul 2019 → Mar 2024 Plasmodium vivax malaria Pyae Linn Aung Unknown No outcome recorded
— NCT03610399 Apr 2018 → Mar 2019 Plasmodium vivax malaria Centers for Disease Control and Prevention Completed No outcome recorded
— NCT02721186 Apr → Dec 2016 malaria Ulrika Morris Completed Missed primary
— NCT01814683 Jul 2014 → Feb 2018 Plasmodium vivax malaria University of Oxford Completed No outcome recorded
Comparator or background therapy38 trials
Phase 1 NCT06294912 Background Apr 2024 → Jan 2025 malaria Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT03934450 Comparator Aug 2018 → May 2019 G6PD deficiency, malaria University of Mississippi, Oxford Completed No outcome recorded
Phase 1 NCT02223871 Background Jun → Jul 2014 — Idorsia Pharmaceuticals Ltd. Completed No outcome recorded
Phase 1 NCT01205178 Comparator Jul 2009 → Apr 2013 malaria GlaxoSmithKline Completed No outcome recorded
Phase 1/2 NCT04280692 Background Aug 2022 → Dec 2025 Plasmodium falciparum malaria University of Oxford Suspended No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2019-01-16 GlaxoSmithKline Results Two positive phase III studies of tafenoquine for the radical cure of Plasmodium vivax malaria published in The New England Journal of Medicine gsk.com ↗
Further, a significantly greater proportion of patients in the primaquine group were relapse-free over the 6-month follow-up period compared with patients on placebo (69.6% vs 27.7%), with an odds ratio of 0.26, p<0.001.

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 118 sources stand behind the page.

FieldValueCited text
Known as Primaquine “If the enzyme activity is normal and no other contra-indication for treatment are found, the participants will be treated with 14 days of primaquine 0.25mg/kg/day OR 7 days of...” NCT06923592 ↗
116

“Each participant will receive a single low dose primaquine on the day of vaccination (Day 0) at Month 0, Month 1, and Month 2. One single low dose primaquine of approximately...” NCT05252845 ↗

“The fMDA regimen will include 25mg/kg chloroquine (CQ) plus a single 300mg dose of tafenoquine (TQ) for individuals age ≥16 years, and 25mg/kg of CQ plus 7 days of 0.5mg/kg/day...” PMID 40321759 ↗ Apr 2025

“Primaquine is an effective gametocytocidal for P. falciparum transmission prevention and as tissue killing for the radical cure in Plasmodium vivax and Plasmodium ovale infection.” NCT01525511 ↗

“Dihydroartemisinin-piperaquine + Primaquine: DHA-P 7mg/kg/day dihydroartemisinin and 55mg/kg/day piperaquine daily for 3 days and Primaquine 1 mg/kg once daily for 7 days” NCT01640574 ↗

“Pharmacokinetic and Mosquito-Lethal Effects of Ivermectin (IVM), Primaquine (PQ), Dihydroartemisinin-Piperaquine (DHA-PQP) and Albendazole (ABZ) in Healthy Subjects” NCT02568098 ↗

“Primaquine is effective against Plasmodium falciparum gametocytes and recommended for treatment campaigns in (pre-)elimination settings.” PMID 25887344 ↗ Mar 2015

“with oral dihydroartemisinin-piperaquine plus either a supervised or unsupervised 14-day course of oral primaquine (0·5 mg/kg per day).” PMID 34710363 ↗ Oct 2021

“One single low dose primaquine of approximately 0.25 mg/kg (Thai Government Pharmaceutical Organisation) will be administered.” NCT06068530 ↗

“Daily Primaquine (0.5 mg of base/kg/day for seven days) starting only at the fifth day post chloroquine initiation.” NCT03529396 ↗

“single oral dose of 30 mg (base) primaquine, 600 mg (base) chloroquine, and the two drugs together” PMID 24687509 ↗ Mar 2014

Show 106 more sources
Known as LD PQ “One dose of 15 mg primaquine. Low dose primaquine (LD PQ) is used to clear mature gametocytes of P. falciparum.” NCT04661579 ↗
Known as PQ base “primaquine (PQ base, Radboud University Nijmegen, The Netherlands: 0.75 mg/kg)” NCT00509015 ↗
Known as Primaquine GPO “Primaquine GPO® (Government Pharmaceutical Organization, Thailand) 0.5 mg/kg will be given once daily for 14 days.” NCT01780753 ↗
Known as primaquine phosphate “Commercially available primaquine containing primaquine phosphate united states pharmacopeia (USP), 26.3 mg (equivalent to primaquine base 15 mg) will be utilized in this study.” NCT02216123 ↗
2

“Positive cases will be treated with age-appropriate doses of Artemether-lumefantrine (AL) and Primaquine Phosphate (SLD-PQ)” NCT03783299 ↗

NCT03934450 ↗
Known as SLD-PQ “Positive cases will be treated with age-appropriate doses of Artemether-lumefantrine (AL) and Primaquine Phosphate (SLD-PQ)” NCT03783299 ↗
Modality Small molecule “Primaquine (PQ) is another 8 aminoquinoline drug available for Malaria treatment” NCT01205178 ↗
Route Oral “two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of...” NCT00000640 ↗