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

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

TADORE+: Tafenoquine and DHA-piperaquine (TADORE- Plus) (clinicaltrials.gov) - P4 | N=507 | Not yet recruiting | Sponsor: Menzies School of Health Research | N=280 ➔ 507 | Trial completion date: Dec 2027 ➔ Jun 2028 | Initiation date: Nov 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2027 ➔ Jun 2028

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

Radical Cure (RC) With Tafenoquine or Primaquine After Semi-quantitative G6PD Testing: A Feasibility Study in Peru (clinicaltrials.gov) - P=N/A | N=987 | Completed | Sponsor: Medicines for Malaria Venture | Recruiting ➔ Completed | N=40 ➔ 987

Enrollment change • Trial completion • 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

New P2 trial • Infectious Disease • Malaria

Strategic resource allocation for malaria elimination in endemic settings: a systematic review of cost-effectiveness evidence. (PubMed, Front Public Health) - "Combined approaches enhanced effectiveness in high-resistance or high-burden settings, while complex strategies, such as tafenoquine with G6PD screening, showed higher ICERs due to additional costs and operational challenges...A socio-ecological framework underscores the need to align policies with economic evidence for optimal resource allocation and accelerated malaria elimination. https://www.crd.york.ac.uk/PROSPERO/view/CRD42024546911, PROSPERO Registration: CRD42024546911."

HEOR • Journal • Review • Infectious Disease • Malaria

Resolving haplotypes of the glucose-6-phosphate dehydrogenase gene using long-range polymerase chain reaction and Oxford Nanopore sequencing. (PubMed, Biol Methods Protoc) - "Glucose-6-phosphate dehydrogenase (G6PD) deficiency is the most common human enzymopathy and poses a major concern on safe administration of oxidative drugs, including antimalarials such as primaquine and tafenoquine. Nanopore sequencing generated long reads (N50 ∼11 kb) with deep coverage (>700-fold), supporting accurate variant detection and phasing. These findings demonstrate the feasibility and robustness of a nanopore-based long-read approach for comprehensive G6PD haplotyping, integrating variant detection and phasing within a single analytical workflow, and providing a foundation for future studies on carrier detection and other X-linked genes."

Journal • Polymerase Chain Reaction • Infectious Disease • Metabolic Disorders

Plasmodium falciparum field isolates drug susceptibility in Mali. (PubMed, JAC Antimicrob Resist) - "Parasites were exposed to 14 drugs, including tafenoquine, N-desethyl-amodiaquine, chloroquine, dihydroartemisinin, lumefantrine, pyronaridine, quinine, sulfadoxine, pyrimethamine, amodiaquine, atovaquone, GNF179, KDU691 and cabamiquine. While current frontline therapies remain effective, reduced activity of chemopreventive antimalarials supports the need for continued surveillance to detect early signs of resistance in Mali. The potent activity of next-generation candidates (cabamiquine and GNF179) supports their potential for further clinical development and field deployment."

Journal • Infectious Disease • Malaria

Effectiveness and safety of 7-day high-dose primaquine and single-dose tafenoquine versus 14-day low-dose primaquine in patients with Plasmodium vivax malaria (EFFORT): a multicentre, open-label, randomised, controlled, superiority trial. (PubMed, Lancet Infect Dis) - P3 | "Both unsupervised 7-day high-dose primaquine and single-dose tafenoquine were well tolerated in patients with normal G6PD activity and they had a lower risk of P vivax recurrence compared with those in the 14-day low-dose primaquine group, albeit with uncertain magnitude. Our findings support the effectiveness and operational feasibility of shorter radical cure regimens across diverse malaria-endemic settings."

Head-to-Head • Journal • CNS Disorders • Hematological Disorders • Infectious Disease • Malaria • Psychiatry • Schizophrenia

Investigating the Pharmacology of Tafenoquine in Papua New Guinean Children With Uncomplicated Malaria (clinicaltrials.gov) - P4 | N=60 | Not yet recruiting | Sponsor: Curtin University

New P4 trial • Infectious Disease • Malaria

Case Report: Management of Uncomplicated Plasmodium Vivax in a Pregnant, G6PD-deficient Patient (WRMC 2026) - "Before receiving the G6PD results, the patient was empirically treated with quinine and clindamycin for seven days...The patient was recommended to stay on hydroxychloroquine prophylaxis until delivery...Chloroquine treatment is followed by primaquine or tafenoquine due to its ability to eliminate parasites in the blood and treat the liver stage of infection...Clinicians are urged to proactively test for G6PD deficiency and select the appropriate type of testing to inform safe administration of antimalarial drugs like primaquine postpartum. Individualized, multidisciplinary treatment and follow-up over the long term are necessary to maximize outcomes and prevent relapse for this high-risk population."

Case report • Clinical • Hematological Disorders • Infectious Disease • Malaria • Metabolic Disorders • Thrombocytopenia

Acute Hemolytic Anemia Due to Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency Triggered by Helicobacter pylori Quadruple Therapy in a Jehovah's Witness: A Case Report. (PubMed, Cureus) - "Although some drugs like antimalarials (primaquine, tafenoquine), sulfonamides, and dapsone are well-known triggers of hemolysis, reports of this adverse effect are rare with standard bismuth-based quadruple therapy for Helicobacter pylori. In this report, we present a 65-year-old male who developed profound anemia (hemoglobin 5.8 g/dL, drop of 4.4 points from baseline) within hours of initiating metronidazole- and tetracycline-containing quadruple therapy...Regarding H. pylori treatment, the patient was initiated on triple therapy (clarithromycin, amoxicillin, proton pump inhibitor), without recurrence of hemolysis...Clinicians should maintain a high suspicion for G6PD deficiency in high-risk populations and exercise caution when prescribing oxidative regimens for H. pylori in these patients."

Journal • Anemia • Hematological Disorders • Infectious Disease • Metabolic Disorders

Tafenoquine succinate inhibits the growth of the equine piroplasmosis hemoparasites Theileria equi and Babesia caballi. (PubMed, Parasit Vectors) - "TFQ significantly inhibited T. equi and B. caballi growth at doses tolerated by equine PBMCs, supporting its potential as an alternative treatment for EP and warranting further in vivo study."

Journal • Hematological Disorders

Pharmacokinetic (PK) Study of Tafenoquine in Healthy Adults (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: State University of New York - Upstate Medical University

New P1 trial

Suboptimal primaquine adherence in Plasmodium vivax malaria: Evidence from high-burden tribal districts in Odisha. (PubMed, J Infect Public Health) - "Suboptimal primaquine adherence delays P. vivax elimination despite adequate drug supply and correct dosing. Addressing behavioral drivers of early treatment cessation is critical to interrupt relapse transmission. Programmatic focus should include intensified social behavior change communication, targeted directly observed therapy, and evaluation of shorter primaquine or single-dose tafenoquine treatments with G6PD testing to enhance radical cure and accelerate India's 2030 malaria elimination goal."

Journal • Infectious Disease • Malaria

Vivax Elimination With Tafenoquine (VET) Study (clinicaltrials.gov) - P4 | N=1242 | Completed | Sponsor: Shoklo Malaria Research Unit | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Malaria

Moving towards high-dose primaquine or single-dose tafenoquine for Plasmodium vivax treatment in Cambodia: a meeting report from dissemination of results of the EFFORT trial to stakeholders. (PubMed, Malar J) - "In addition, data were collected on the feasibility and cost-effectiveness of these treatment options. CNM organized the national dissemination of the EFFORT study results on March 27, 2025, to inform key stakeholders and discuss the implications of the study findings for policy and practice in Cambodia."

Journal • Infectious Disease • Malaria • Metabolic Disorders

Rapid detection of G6PD deficiency SNPs using a novel amplicon-based minion sequencing assay. (PubMed, Sci Rep) - "Radical cure of P. vivax malaria requires administration of a hypnozoitocidal drug, such as primaquine or tafenoquine. The assay demonstrated reliable detection of known variants, with high concordance between runs, within runs, and with Sanger sequencing. The Nanopore MinION long-amplicon sequencing assay offers a robust and portable solution for large-scale G6PD genotyping in low-resource settings, that will improve malaria control and elimination strategies by enabling safer antimalarial treatment."

Journal • Hematological Disorders • Infectious Disease • Malaria • Metabolic Disorders • G6PD

Development and Validation of a Stability-Indicating HPLC-UV Assay for Quantification of Tafenoquine Succinate in a Novel Paediatric Antimalarial Formulation. (PubMed, Biomed Chromatogr) - "Forced degradation showed tafenoquine's susceptibility to acidic (29.33%), basic (18.83%), photolytic (complete degradation by day 14), and oxidative (8.33%) stress, with complete chromatographic separation from degradation products. This robust, rapid and low-cost assay is suitable for routine content and stability testing, is adaptable to other tafenoquine formulations and can be further applied to clinical settings."

Journal • Infectious Disease • Malaria • Pediatrics

Repurposing the USFDA-approved small molecules for their affinity against the colchicine binding site (CBS) in the tubulin: Corroborating the in-silico findings through biological assessment. (PubMed, Bioorg Med Chem) - "Tafenoquine was found to exert broad-spectrum antiproliferative effects, with greatest potency against MDA-MB-231 cells (IC₅₀ = 4.75 ± 0.18 μM), a model for aggressive and treatment-resistant triple-negative breast cancer (TNBC). Considering the tubulin polymerization assay, the identified hit was found to inhibit microtubule assembly (low Vmax) in a manner similar to colchicine, and exhibited a similar G2/M arrest, indicating a mode of inhibition similar to that of colchicine."

FDA event • Journal • Breast Cancer • Colon Cancer • Infectious Disease • Oncology • Solid Tumor • Triple Negative Breast Cancer

Tafenoquine lactation pharmacokinetics: a pilot study. (PubMed, Malar J) - "This pilot study demonstrated measurable tafenoquine in breastmilk, with very small amounts of drug passing to babies on any given day but overall estimated RIDs around the conventional 10% threshold for safety concerns. Further studies are needed to determine with greater certainty the excretion of tafenoquine in breastmilk and drug concentrations in infant blood to inform recommendations for breastfeeding women."

Journal • PK/PD data • Hematological Disorders • Infectious Disease • Malaria

TQ-BA-2024-1: Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: 60 Degrees Pharmaceuticals LLC | Trial completion date: Jul 2025 ➔ Jul 2027 | Trial primary completion date: Mar 2025 ➔ Mar 2027

Trial completion date • Trial primary completion date

TQ-BA-2024-3: B-FREE Chronic Babesiosis Study (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: 60 Degrees Pharmaceuticals LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Fatigue