Application of the Stable Isotope Label Approach in Clinical Development—Supporting Dissolution Specifications for a Commercial Tablet Product with Tafenoquine, a Long Half-life Compound

Tafenoquine is an 8-aminoquinoline with activity against all human life cycle stages of Plasmodium vivax, including dormant liver stages – so called hypnozoites. Its long half-life of ~15 days is allowing for a single exposure regimen. It has been under development since 1980 and received approval by the US Food and Drug Administration in summer 2018 as an anti-relapse drug for P. vivax malaria in patients aged 16 years and older and for prophylaxis of malaria caused by any Plasmodium species in adults. Prior to tafenoquine administration, glucose-6-phosphate dehydrogenase (G6PD) deficiency needs to be excluded by testing. Individuals with a deficient G6PD activity are at risk of tafenoquine-induced hemolysis – as is the case for primaquine, the mainstay drug for P. vivax radical cure. A wealth of clinical studies have been conducted and are still ongoing to assess the safety, tolerability, and efficacy of tafenoquine. This review focuses on data emerging from the latest clinical trials on P. vivax radical cure with tafenoquine, the key studies for regulatory approval of tafenoquine, and elucidates the latest hypothesis on the mode of action.

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Application of the Stable Isotope Label Approach in Clinical Development—Supporting Dissolution Specifications for a Commercial Tablet Product with Tafenoquine, a Long Half-life Compound

Abstract: This study (GSK study number 201780) is registered at clinicaltrials.gov with identifier NCT02751294.

Cited by 2 publications

References 8 publications

Evaluation of Therapeutic Equivalence for the Follow-On Version of Intravenously Administered Non-Biological Complex Drugs

Evaluation of Therapeutic Equivalence for the Follow-On Version of Intravenously Administered Non-Biological Complex Drugs

<p>Clinical utility of tafenoquine in the prevention of relapse of <em>Plasmodium vivax</em> malaria: a review on the mode of action and emerging trial data</p>

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