A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in the Treatment of Subjects With Plasmodium Vivax Malaria
Phase of Trial: Phase III
Latest Information Update: 08 Feb 2018
At a glance
- Drugs Tafenoquine (Primary) ; Chloroquine; Primaquine
- Indications Malaria
- Focus Registrational; Therapeutic Use
- Acronyms GATHER
- Sponsors GlaxoSmithKline
- 08 Feb 2018 The US FDA has granted priority review designation for Tafenoquine for prevention of malaria in adults traveling to areas where the disease is prevalent. The USFDA goal for completing a priority review of an NDA is six months, according to a 60 Degrees Pharmaceuticals media release.
- 14 Dec 2017 According to a company media release, GSK and Medicines for Malaria Venture (MMV) have submitted a regulatory application to the Australian Therapeutics Good Administration (TGA) seeking approval of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients 16 years of age and older. The regulatory submission included data from GATHER and DETECTIVE trials.
- 28 Nov 2017 According to a GlaxoSmithKline media release, the company has submitted a New Drug Application (NDA) to the US FDA seeking approval of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients 16 years of age and older. The NDA submission included data from GATHER and DETECTIVE trials.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History