Clinical Trials

Numerous clinical trials evaluate tafenoquine across therapeutic contexts, primarily malaria prophylaxis, radical cure of Plasmodium vivax and falciparum parasitaemia, uncomplicated malaria, and chronic babesiosis. Spanning Early Phase 1 through Phase 4 in healthy volunteers and lactating women, these studies are sponsored by pharmaceutical entities including GlaxoSmithKline and 60 Degrees Pharmaceuticals alongside governmental and academic institutions such as the U.S. Army and University of Oxford. Reflecting ongoing optimization of dosing and safety, trial recruitment statuses encompass completed, recruiting, not yet recruiting, and withdrawn studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07430592 NOT_YET_RECRUITING
Malaria; Malaria Vivax; Radical Cure
R. Kiplin Guy
 2026-10-01 PHASE2
NCT07533136 NOT_YET_RECRUITING
Uncomplicated P. Vivax Mono-infection
Walter Reed Army Institute of Research (WRAIR)
 2026-05-01
NCT07060794 NOT_YET_RECRUITING
Vivax Malaria
Menzies School of Health Research
 2026-06 PHASE4
NCT04704999 RECRUITING
Plasmodium Vivax Malaria
University of Oxford
 2024-07-22 PHASE4
NCT06207370 RECRUITING
Babesiosis
60 Degrees Pharmaceuticals LLC
 2024-06-17 PHASE2
NCT06148792 RECRUITING
Vivax Malaria
Menzies School of Health Research
 2024-05-10 PHASE3
NCT07373743 NOT_YET_RECRUITING
Pharmacokinetic in Normal Population
State University of New York - Upstate Medical University
 2026-05 EARLY_PHASE1
NCT06656351 RECRUITING
Chronic Babesiosis
60 Degrees Pharmaceuticals LLC
 2025-11-18 PHASE2
NCT07403643 NOT_YET_RECRUITING
Uncomplicated Malaria
Curtin University
 2026-04 PHASE4
NCT07060404 NOT_YET_RECRUITING
Drug Pharmacokinetics in Healthy Volunteers
Curtin University
 2026-04 PHASE2; PHASE3
NCT06666491 RECRUITING
Malaria, Vivax
GlaxoSmithKline
 2024-11-13 PHASE3
NCT07052162 RECRUITING
Pharmacokinetics of Tafenoquine
Curtin University
 2025-10-20 PHASE4
NCT05788094 RECRUITING
Malaria; Malaria, Vivax; Plasmodium Vivax Malaria
Shoklo Malaria Research Unit
 2023-06-26 PHASE4
NCT06575647 COMPLETED
Malaria; Malaria, Vivax; Plasmodium Vivax; Plasmodium Vivax Malaria
Shoklo Malaria Research Unit
 2025-02-19 PHASE4
NCT04984759 WITHDRAWN
Healthy Lactating Women
University of Oxford
 2023-07-01 PHASE4
NCT04411836 COMPLETED
Vivax Malaria; Plasmodium Vivax; Malaria, Vivax; Malaria Relapse
Menzies School of Health Research
 2021-04-25 PHASE3
NCT05947812 UNKNOWN
COVID 19 Disease; Mild to Moderate COVID 19 Disease; SARS-CoV-2; Infectious Disease; Severe Acute Respiratory Syndrome Coronavirus 2
60P Australia Pty Ltd
 2023-08-01 PHASE2
NCT04984759 Withdrawn
Healthy Lactating Women
University of Oxford|Mahidol Oxford Tropical Medicine Research Unit
 2023-07-01 Phase 4
NCT05203744 UNKNOWN
Prophylaxis
Naval Medical Research Center
 2022-05-10 PHASE4
NCT04533347 COMPLETED
COVID 19 Disease
60 Degrees Pharmaceuticals LLC
 2021-02-19 PHASE2
NCT05203744 Unknown status
Prophylaxis
Naval Medical Research Center|Naval Medical Research Unit TWO (NAMRU-2)|Australian Defence Force Malaria and Infectious Disease Institute (ADF MIDI)|The 108 Military Central Hospital|Naval Environmental Preventive Medicine Unit TWO (NEPMU-2)
 2022-05-10 Phase 4
NCT05081089 COMPLETED
Malaria,Falciparum
London School of Hygiene and Tropical Medicine
 2021-10-12 PHASE2
NCT03320174 COMPLETED
Healthy Volunteers
60 Degrees Pharmaceuticals LLC
 2017-10-05 PHASE2
NCT04609098 COMPLETED
Malaria, Falciparum
London School of Hygiene and Tropical Medicine
 2020-10-29 PHASE2
NCT02563496 COMPLETED
Malaria, Vivax
GlaxoSmithKline
 2017-02-06 PHASE2
NCT02802501 COMPLETED
Malaria, Vivax
GlaxoSmithKline
 2018-04-08 PHASE3
NCT02658435 COMPLETED
Malaria, Vivax
GlaxoSmithKline
 2016-02-02 PHASE1
NCT02563496 Completed
Malaria Vivax
GlaxoSmithKline|Medicines for Malaria Venture
 2017-02-06 Phase 2
NCT01376167 COMPLETED
Malaria, Vivax
GlaxoSmithKline
 2014-04-24 PHASE2
NCT02216123 COMPLETED
Malaria, Vivax
GlaxoSmithKline
 2015-04-30 PHASE3
NCT02751294 COMPLETED
Malaria, Vivax
GlaxoSmithKline
 2016-05 PHASE1
NCT02184637 COMPLETED
Malaria, Vivax
GlaxoSmithKline
 2014-07-31 PHASE1
NCT01205178 COMPLETED
Malaria
GlaxoSmithKline
 2009-07-02 PHASE1
NCT01928914 COMPLETED
Malaria, Vivax
GlaxoSmithKline
 2011-07-26 PHASE1
NCT00871156 COMPLETED
Malaria
GlaxoSmithKline
 2009-03-24 PHASE1
NCT01290601 TERMINATED
Malaria; Plasmodium Vivax
U.S. Army Medical Research and Development Command
 2003-09-15 PHASE2
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
NCT02491606 COMPLETED
Malaria
U.S. Army Medical Research and Development Command
 1997-05 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an 8-aminoquinoline antimalarial agent, tafenoquine generates intracellular reactive oxygen species and disrupts parasitic mitochondrial membrane function, blocking essential metabolic redox pathways. This systemic organelle damage causes rapid parasite cell lysis, providing the mechanistic basis for its clinical efficacy in malaria prophylaxis, radical cure of Plasmodium vivax, and management of chronic babesiosis.

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.