Primaquine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | PRIMAQUINE | — | 1952-01-23 | fda.gov ↗ |
Trials 81 · started per year
Also used as a comparator or background therapy in 37 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 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 1/23 trials | ||||||
| Phase 1/2 | NCT04280692 Background | Aug 2022 → Dec 2025 | Plasmodium falciparum malaria | University of Oxford | Suspended | No outcome recorded |
| Phase 1/2 | NCT02802813 Comparator | Jun 2016 → Jun 2018 | Plasmodium vivax malaria | University of Oxford | Completed | No outcome recorded |
| Phase 1/2 | NCT02431650 Comparator | Apr 2015 → Sep 2016 | malaria | Medicines for Malaria Venture | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT05044637 Comparator | Aug 2021 → Jul 2024 | Plasmodium vivax malaria | Fundação de Medicina Tropical Dr. Heitor Vieira Dourado | Completed | No outcome recorded |
| Phase 2 | NCT04661579 Background | Nov 2020 → Jun 2022 | Plasmodium falciparum malaria | PATH | Completed | No outcome recorded |
| Phase 2 | NCT03529396 Comparator | Jul 2018 → Dec 2022 | G6PD deficiency, Plasmodium vivax malaria | Fundação de Medicina Tropical Dr. Heitor Vieira Dourado | Completed | No outcome recorded |
| Phase 2 | NCT02851108 Comparator | Oct → Dec 2016 | Plasmodium falciparum malaria | Heidelberg University | Completed | No outcome recorded |
| Phase 2 | NCT02696928 Comparator | Apr 2016 → Oct 2017 | Plasmodium vivax malaria | Heidelberg University | Withdrawn | No outcome recorded |
| Phase 2 | NCT01376167 Comparator | Apr 2014 → Nov 2016 | Plasmodium vivax malaria | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01290601 Comparator | Sep 2003 → Jan 2005 | Plasmodium vivax malaria | U.S. Army Medical Research and Development Command | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02691910 Comparator | Aug 2014 → Aug 2015 | Plasmodium vivax malaria | Oswaldo Cruz Foundation | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT06666491 Comparator | Nov 2024 → May 2026 overdue | Plasmodium vivax malaria | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT03208907 Comparator | Jul 2018 → Jul 2021 | Plasmodium vivax malaria | Fundação de Medicina Tropical Dr. Heitor Vieira Dourado | Completed | No outcome recorded |
| Phase 3 | NCT02802501 Comparator | Apr 2018 → Aug 2019 | Plasmodium vivax malaria | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT03355664 Background | Mar 2018 → Mar 2020 | Plasmodium falciparum malaria | University of Oxford | Completed | No outcome recorded |
| Phase 3 | NCT02348788 Comparator | Jan 2015 → Dec 2017 | Plasmodium vivax malaria | Menzies School of Health Research | Unknown | No outcome recorded |
| Phase 3 | NCT01708876 Comparator | Oct 2012 → Dec 2014 | — | Menzies School of Health Research | Completed | No outcome recorded |
| Phase 3 | NCT01288820 Background | Jan 2011 → Apr 2012 | Plasmodium vivax malaria | University of Oxford | Completed | No outcome recorded |
| Phase 411 trials | ||||||
| Phase 4 | NCT06068530 Comparator | Feb 2025 → Feb 2028 expected | Plasmodium falciparum malaria | University of Oxford | Recruiting | No outcome recorded |
| Phase 4 | NCT07468513 Comparator | May 2024 → Jun 2028 expected | G6PD deficiency, Plasmodium vivax malaria | Menzies School of Health Research | Recruiting | No outcome recorded |
| Phase 4 | NCT03783299 Background | Nov 2017 → Nov 2018 | Plasmodium falciparum malaria | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT02787070 Comparator | Sep 2016 → Nov 2018 | malaria | Menzies School of Health Research | Completed | No outcome recorded |
| Phase 4 | NCT02793388 Comparator | Sep 2016 → Sep 2017 | malaria | Menzies School of Health Research | Withdrawn | 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 | NCT02592408 Comparator | Nov 2015 → May 2016 | malaria | Menzies School of Health Research | Completed | No outcome recorded |
| Phase 4 | NCT02364583 Comparator | Jun 2010 → Jun 2016 | Plasmodium vivax malaria | Papua New Guinea Institute of Medical Research | Unknown | No outcome recorded |
| Phase 4 | NCT02143934 Comparator | Aug 2009 → May 2010 | Plasmodium falciparum malaria, Plasmodium vivax malaria | Papua New Guinea Institute of Medical Research | Completed | No outcome recorded |
| Phase 4 | NCT01392014 Comparator | Dec 2008 → Mar 2010 | Plasmodium falciparum malaria | Indonesia University | Completed | No outcome recorded |
| Phase 4 | NCT00636935 Background | Feb 2008 → Aug 2013 | pneumocystosis | George Washington University | Withdrawn | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT07389057 Comparator | Nov 2023 → Nov 2026 expected | Plasmodium falciparum malaria, parasitemia | Noguchi Memorial Institute for Medical Research | Recruiting | No outcome recorded |
| — | NCT01837992 Comparator | May 2013 → May 2014 | malaria | Menzies School of Health Research | Unknown | No outcome recorded |
| — | NCT01849640 Comparator | Dec 2012 → Dec 2014 | Plasmodium falciparum malaria | David Saunders | Suspended | No outcome recorded |
| — | NCT00509015 Comparator | Feb → Aug 2008 | Plasmodium falciparum malaria | Radboud University Medical Center | Completed | No outcome recorded |
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 119 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Primaquine | “participants with a positive P. vivax serology at baseline or month 6 will be approached for treatment. First G6PD enzyme activity will be measured. If the enzyme activity is...” NCT06923592 ↗115“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 “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 ↗ “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 “antibiotics (Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, or Trimethoprim/Dapsone)” NCT00636935 ↗ “Primaquine (15 mg oral tablets) was administered once daily for 14 days” PMID 42114535 ↗ May 2026 “Prescription of short course primaquine (7 mg/kg total) (Day 0)” NCT05874271 ↗ “Prescription of short course primaquine (7 mg/kg total)(Day 0)” NCT05879224 ↗ “primaquine (PQ) 0.5mg/kg single dose by mouth at 84-96 hours” NCT02052323 ↗ “1. Primaquine (PQ) (15 mg tablets): weight-adjusted dosage.” NCT05540470 ↗ “DHA-PIP = Dihydroartemisinin/piperaquine PQ = Primaquine” NCT02992119 ↗ “plus low dose primaquine at hour 24” NCT03355664 ↗ “single dose primaquine on day 2” NCT02592408 ↗ “Arm 2: DHAP + Primaquine (PQ)” NCT07389057 ↗ “Chloroquine and primaquine” NCT02043652 ↗ |
| Known as | Camden | ChEMBL registry synonym — accepted as the source's own label CHEMBL506 ↗ |
| Known as | Kanaprim | ChEMBL registry synonym — accepted as the source's own label CHEMBL506 ↗ |
| 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 | Maliride | ChEMBL registry synonym — accepted as the source's own label CHEMBL506 ↗ |
| Known as | Malquine | ChEMBL registry synonym — accepted as the source's own label CHEMBL506 ↗ |
| Known as | Neo-quipenyl | ChEMBL registry synonym — accepted as the source's own label CHEMBL506 ↗ |
| Known as | NSC-149765 | ChEMBL registry synonym — accepted as the source's own label CHEMBL506 ↗ |
| Known as | NSC-27296 | ChEMBL registry synonym — accepted as the source's own label CHEMBL506 ↗ |
| Known as | PQ base | “primaquine (PQ base, Radboud University Nijmegen, The Netherlands: 0.75 mg/kg)” NCT00509015 ↗ |
| Known as | Primachin | ChEMBL registry synonym — accepted as the source's own label CHEMBL506 ↗ |
| Known as | Primaquina | ChEMBL registry synonym — accepted as the source's own label CHEMBL506 ↗ |
| Known as | Primaquine Diphosphate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04049916 ↗ |
| 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 ↗ |
| Known as | Primaquini diphosphas | ChEMBL registry synonym — accepted as the source's own label CHEMBL506 ↗ |
| Known as | SLD-PQ | “Positive cases will be treated with age-appropriate doses of Artemether-lumefantrine (AL) and Primaquine Phosphate (SLD-PQ)” NCT03783299 ↗ |
| Known as | SN-13272 | ChEMBL registry synonym — accepted as the source's own label CHEMBL506 ↗ |
| Known as | WR 2975 | ChEMBL registry synonym — accepted as the source's own label CHEMBL506 ↗ |
| 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 ↗ |