Prevents malaria. Sold as Arakoda, Krintafel. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 2 applications for Tafenoquine Succinate (sold as Arakoda, Krintafel), first approved Jul 20, 2018, with 0 new uses approved and 0 published complete response letters.
| Tafenoquine Drug Levels in Small ChildrenPlasmodium Vivax Malaria, Vivax Malaria · University of Oxford | Phase 2 | Not yet recruiting | Sep 22, 2026 |
| Tafenoquine Combinations for Improved Radical Cure Efficacy of Plasmodium VivaxUncomplicated P. Vivax Mono-infection · Walter Reed Army Institute of Research (WRAIR) | Not applicable | Not yet recruiting | Apr 16, 2026 |
| This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Safe and Rapidly Acting Anti-malarial for the Radical Cure of P. Vivax MalariaMalaria, Malaria Vivax · R. Kiplin Guy | Phase 2 | Not yet recruiting | Feb 24, 2026 |
| Investigating the Pharmacology of Tafenoquine in Papua New Guinean Children With Uncomplicated MalariaUncomplicated Malaria · Curtin University | Phase 4 | Not yet recruiting | Feb 11, 2026 |
| Pharmacokinetic (PK) Study of Tafenoquine in Healthy AdultsPharmacokinetic in Normal Population · State University of New York - Upstate Medical University | Early phase 1 | Not yet recruiting | Jan 28, 2026 |
| Postpartum 8-aminoquinoline Breast Milk StudyDrug Pharmacokinetics in Healthy Volunteers · Curtin University | Phase 2 / Phase 3 | Not yet recruiting | Jul 11, 2025 |
| Tafenoquine and ACTs (TADORE- Plus)Vivax Malaria · Menzies School of Health Research | Phase 4 | Not yet recruiting | Jul 11, 2025 |
| Investigating the Pharmacokinetics of Tafenoquine in Healthy Papua New Guinean ChildrenPharmacokinetics of Tafenoquine · Curtin University | Phase 4 | Recruiting | Jul 4, 2025 |
| Jul 20, 2018 | KrintafelNDA 210795 · New molecular entity | Glaxosmithkline | 1 | Marketed |
| Aug 8, 2018 | ArakodaNDA 210607 · New formulation or manufacturer | 60 Degrees Pharms | 1 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Glaxosmithkline