Krintafel (tafenoquine) / GSK, Medicines for Malaria Venture, 60° Pharma - LARVOL DELTA

LC-triple quadrupole-MS based quantitative analysis of tafenoquine in rat plasma and red blood cells: method development and validation. (PubMed, Bioanalysis) - "Matrix effect, recovery and stability studies also gave promising results for RBCs as well as the plasma matrix. The method will allow accurate evaluation of cellular-level pharmacokinetics, drug-drug interactions, and bioavailability of Tafenoquine, providing a strong foundation for antimalarial drug discovery research in a preclinical setup."

Journal • Preclinical • Infectious Disease

TQP: Tafenoquine Drug Levels in Small Children (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: University of Oxford

New P2 trial • Infectious Disease • Malaria

Pharmacokinetics and Pharmacodynamics of Antimalarial Agents: Optimizing Combination Therapies to Overcome Resistance Mechanisms. (PubMed, J Clin Pharmacol) - "A discussion of PK/PD modeling across agents, including chloroquine, artemisinin and its derivatives, mefloquine, primaquine, and tafenoquine, highlights how inadequate drug exposure, mismatched partner drug kinetics, and host metabolic variability contribute to treatment failure. Collectively, the evidence suggests that refining combination regimens through PK/PD-guided dose optimization is crucial for maintaining efficacy and preventing resistance. Future research must prioritize host-specific factors, stage-specific drug activity, and optimized combination regimens to improve therapeutic outcomes and support malaria eradication."

Journal • PK/PD data • Review • Infectious Disease • Malaria

Drug-associated bipolar disorder: A disproportionality analysis of the FAERS database. (PubMed, Psychiatry Res) - "Most high BD-signal drugs lack label warnings. Drug-induced BD presents distinct sex and subtype-specific risks, requiring gender- and subtype-personalized clinical monitoring."

Journal • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry

Physiologically based pharmacokinetic modeling of tafenoquine and evaluation of transporter-mediated drug-drug interactions. (PubMed, Front Pharmacol) - "The qualified model was used to simulate co-administration with metformin (MTF), an OCT2 and MATE1 substrate, and assess drug-drug interactions. Co-administration of TQ with MTF presented no alteration of MTF's exposure. Model simulations suggest that there is no significant interaction between TQ and substrates of OCT2/MATE1, such as MTF."

Journal • PK/PD data • Infectious Disease • Malaria

Building the toolkit to address malaria resurgence and radical cure of vivax malaria in Ethiopia: a meeting report. (PubMed, Malar J) - "At the same time, new evidence supporting improved radical cure strategies, including high-dose primaquine and single-dose tafenoquine, alongside advances in molecular tools, offers opportunities to address persistent transmission and relapse. The meeting highlighted that, while more effective tools for P. vivax radical cure are available, their adoption in Ethiopia will depend on addressing key evidence gaps, particularly around relapse burden, feasibility, and cost-effectiveness. Given the current challenges, there is a pressing need for context specific research and continued dialogue between stakeholders, which will be critical to inform policy decisions and support progress towards malaria elimination."

Journal • Infectious Disease • Malaria

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 Malaria (clinicaltrials.gov) - P2 | N=104 | Not yet recruiting | Sponsor: R. Kiplin Guy | Initiation date: Jul 2026 ➔ Oct 2026

Trial initiation date • Infectious Disease • Malaria

Interdisciplinary and Participatory Research for the Elimination of Socially Determined Diseases in the Amazon: A Narrative Review. (PubMed, Rev Soc Bras Med Trop) - "In malaria elimination, research emphasized evaluating the acceptability and feasibility of new tools such as point-of-care G6PD testing and single-dose tafenoquine, demonstrating that understanding perceptions of innovations is indispensable for effective implementation...Extreme climate events, such as the 2023 Amazon drought, exacerbate vulnerabilities by disrupting livelihoods and healthcare access. The article concludes by proposing an interdisciplinary research agenda aligned with Brazil's Healthy Brazil Program, emphasizing community engagement, intersectional analysis, One Health integration and implementation science as key strategies for equitable disease elimination in the Amazon."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease • Malaria • Ophthalmology

Health-care provider compliance with a revised Plasmodium vivax radical cure algorithm incorporating tafenoquine and quantitative G6PD testing in the Peruvian Amazon: a prospective observational study. (PubMed, Lancet Reg Health Am) - "Historically, radical cure relied on multi-day primaquine regimens, often without prior glucose-6-phosphate dehydrogenase (G6PD) testing. These findings demonstrate that HCP at the participating facilities can successfully implement the revised radical cure algorithm, contributing to the operational evidence base informing its scale-up in Peru and the Americas. Unitaid (Grant number 2021-43-VIV)."

Compliance • Journal • Observational data • Hematological Disorders • Infectious Disease • Malaria

Anti-malarial contact dependent blocking of transmission of Plasmodium vivax by Anopheles darlingi mosquito vector. (PubMed, PLoS Pathog) - "Among the antimalarials evaluated were Atovaquone (ATQ), Tafenoquine (TQ), Chloroquine (CQ), Mefloquine (MQ), Primaquine (PQ), and the compound Nanchangmycin (NCG). In addition, MQ also significantly reduced infection intensity, but there was no difference in infection prevalence. No significant differences were observed for the other antimalarials."

Journal • Infectious Disease • Malaria

Risk perceptions of high-dose primaquine and tafenoquine among Plasmodium vivax malaria stakeholders in Ethiopia: a qualitative study. (PubMed, BMJ Glob Health) - "Participants' perceptions of shortened radical cure regimens were shaped by concerns about effectiveness and safety, influenced by prior treatment messaging and pill characteristics such as higher dosing and pill burden. A risk perception lens can inform implementation and communication strategies for novel regimens, where addressing user perceptions alongside practical improvements, such as reducing pill burden, is essential for optimising uptake and adherence."

Journal • Hematological Disorders • Infectious Disease • Malaria • Metabolic Disorders

Point of care performance of the improved BIOCREDIT Ag Pf/Pv (pLDH/pLDH) rapid diagnostic test: a cross-sectional study at a health center setting in Ethiopia. (PubMed, Malar J) - "The RDT demonstrated strong accuracy for point-of-care, species-specific malaria diagnosis in Ethiopian primary healthcare. Its high sensitivity, particularly for moderate- to high-density infections, supports routine clinical use following Ethiopia's shift to non-HRP2 RDTs."

Journal • Observational data • Infectious Disease • Malaria

Plasmodium vivax malaria in India: microbiological barriers to diagnosis, treatment, and elimination. (PubMed, Clin Microbiol Rev) - "Standard radical cure with chloroquine and 14-day primaquine is limited by poor adherence and restricted glucose-6-phosphate dehydrogenase testing, while single-dose tafenoquine awaits wider implementation. We highlight emerging experimental liver models, single-cell technologies, and systems biology frameworks as essential tools for addressing key knowledge gaps in relapse biology. Sustained investment and interdisciplinary collaboration will be required for India to lead P. vivax elimination and translate national progress into global impact."

Journal • Review • Infectious Disease • Malaria

Efficacy of Delayed Tafenoquine Administration for Radical Cure of Plasmodium vivax Malaria: A Systematic Review. (PubMed, Acta Trop) - "We conducted a systematic review assessing the efficacy of a single dose of TQ (≥300mg) administered three or more days (delayed) after initiation of chloroquine/hydroxychloroquine for blood stage malaria in patients with confirmed infection. However, the data does suggest that delayed TQ is likely better than treatment with chloroquine alone and could be a preferable option to the 14-day primaquine regimen in situations where adherence is unlikely. Clinicians should weigh risks and benefits of each regimen in collaborations with their patients to determine the most appropriate treatment approach."

Journal • Hematological Disorders • Infectious Disease • Malaria • Metabolic Disorders

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 Malaria (clinicaltrials.gov) - P2 | N=104 | Not yet recruiting | Sponsor: R. Kiplin Guy | Initiation date: Mar 2026 ➔ Jul 2026

Trial initiation date • Infectious Disease • Malaria

Dissemination of EFFORT trial results in Indonesia: a stakeholder meeting report on tafenoquine and primaquine for radical cure of Plasmodium vivax. (PubMed, Malar J) - "Stakeholders highlighted the need for further studies on tafenoquine with ACTs, while recognising high-dose primaquine as an immediately implementable option pending strengthened G6PD testing. The discussion emphasised the importance of tailoring strategies to Indonesia's diverse settings, supported by strong political commitment to elimination."

Journal • Infectious Disease • Malaria

Tafenoquine: A Breakthrough Option for Babesiosis Treatment. (PubMed, Trop Med Infect Dis) - "For years, only a few drugs have been used for clinical treatment, namely atovaquone plus azithromycin or clindamycin plus quinine for human, and imidocarb dipropionate and diminazene aceturate for domestic animals. Of these, tafenoquine has shown wide and potent antibabesial activity, offering a new option to control babesiosis. This article aims to present the current clinical therapeutic strategies for babesiosis and their limitations, as well as the prospect of tafenoquine as a promising drug to treat babesiosis."

Journal

Differential impact of Tafenoquine and Primaquine on Plasmodium vivax recurrence: the role of CYP2D6 variants. (PubMed, Antimicrob Agents Chemother) - "Those with a predicted intermediate or poor metabolizer phenotype (gIM + gPM) were more likely to experience recurrence compared to normal metabolizers (gNM) (P = 0.036). Our findings indicate that CYP2D6 does not impact the efficacy of TQ, whereas P. vivax recurrence is associated with predicted metabolic phenotype, with increased risk among patients treated with PQ, suggesting that CYP2D6 variability influences treatment response, particularly in intermediate/poor metabolizers."

Journal • Infectious Disease • Malaria

Tafenoquine Combinations for Improved Radical Cure Efficacy of Plasmodium Vivax (clinicaltrials.gov) - P=N/A | N=300 | Not yet recruiting | Sponsor: Walter Reed Army Institute of Research (WRAIR)

New trial • Infectious Disease

Potent acridone antimalarial against all three life stages of Plasmodium. (PubMed, Nat Commun) - "Attributes of lead candidate T111 include potent in vitro activity against cultured parasites, ex vivo activity against clinical isolates, oral single-dose cure in an asexual blood-stage rodent model, inhibition of sexual blood-stage parasites, activity against relapsing parasites in non-human primate liver cells, prevention of parasite development in mosquitoes, and synergy in combination with tafenoquine against blood- and liver-stage parasites. The safety profile of T111, including toxicology evaluations in rats, absence of hemolytic toxicity, and low genotoxicity and cardiotoxicity potential, demonstrates a favorable therapeutic index. Overall, T111 emerges as a promising candidate for treatment and prevention of malaria, with potential for single-dose cure of bloodstream infections, radical cure of liver infections, and interruption of transmission to mosquitoes."

Journal • Cardiovascular • Infectious Disease • Malaria

G6PD deficiency in Indonesia: a systematic review and update of prevalence and variant maps in the context of malaria elimination. (PubMed, Lancet Reg Health West Pac) - "Low-daily-dose primaquine (PQ) (0·25 mg/kg/day over 14 days) remains the first-line treatment for P. vivax hypnozoites in Indonesia but can trigger haemolysis in glucose-6-phosphate dehydrogenase (G6PD) deficient individuals...This lack of data needs to be addressed to inform and guide appropriate routine G6PDd screening to support P. vivax malaria elimination targets. This work was supported, in whole or in part, by the Bill & Melinda Gates Foundation (INV-024389)."

Journal • Hematological Disorders • Infectious Disease • Malaria • Metabolic Disorders

Expansion of the use of technologies to reduce cases of malaria due to Plasmodium vivax in the Brazilian Amazon: a budget impact analysis (PubMed, Cad Saude Publica) - "Tafenoquine and primaquine are drugs used in the treatment of malaria due to Plasmodium vivax, but can cause hemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency. The cost and waste of the test reagent strips impacted the results. The technologies analyzed can contribute to safer decision-making in the treatment of malaria in the Brazilian Amazon and planning if the technologies under analysis are incorporated."

HEOR • Journal • Hematological Disorders • Infectious Disease • Malaria • Metabolic Disorders

Radical Cure (RC) With Tafenoquine or Primaquine After Semi-quantitative G6PD Testing: A Feasibility Study in Peru (clinicaltrials.gov) - P=N/A | N=187 | Completed | Sponsor: Medicines for Malaria Venture | N=987 ➔ 187

Enrollment change • Infectious Disease • Malaria

Investigating the Pharmacokinetics of Tafenoquine in Healthy Papua New Guinean Children (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: Curtin University | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ Mar 2026 | Initiation date: Jul 2025 ➔ Oct 2025 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease • Malaria

Postpartum 8-aminoquinoline Breast Milk Study (clinicaltrials.gov) - P2/3 | N=60 | Not yet recruiting | Sponsor: Curtin University | Trial completion date: Dec 2026 ➔ May 2027 | Initiation date: Aug 2025 ➔ Apr 2026 | Trial primary completion date: Aug 2026 ➔ Dec 2026

Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease • Malaria