DeepMed Research

Tafenoquine

Generic Name: Tafenoquine

Brand Names: Arakoda, Krintafel

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₈F_₃N_₃O_₃

CAS Number: 106635-80-7

Unique Ingredient Identifier: 262P8GS9L9

Background: Tafenoquine is an 8-aminoquinoline analogue of primaquine which varies only on the presence of a 5-phenoxy group. It was discovered by the scientists at the Walter Reed Army Institute of Research in 1978 as a substitute for primaquine that would be more effective against relapsing vivax malaria. Tafenoquine was further developed collaboratively between GlaxoSmithKline and Medicines for Malaria Venture. It was FDA approved on July 20, 2018.

Indication: 用于16岁及以上疟疾患者，根治(预防复发)由间日疟原虫(P.vivax)导致的疟疾。

Associated Conditions: Malaria caused by plasmodium vivax

Clinical Trials

Assessment of Any Potential Retinal Effects of Tafenoquine (TQ)

Phase 1

Completed

Conditions: Malaria, Vivax

Interventions: Drug: Tafenoquine 150 mg
Drug: Matched placebo 150mg

First Posted Date: 2016-01-18

Last Posted Date: 2018-03-01

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 486

Registration Number: NCT02658435

Locations: 🇺🇸
GSK Investigational Site, Baltimore, Maryland, United States

A Pharmacokinetics, Safety and Efficacy Study of Tafenoquine (TQ) in Pediatric Subjects With Plasmodium Vivax (P. Vivax) Malaria

Phase 2

Completed

Conditions: Malaria, Vivax

Interventions: Drug: Tafenoquine
Drug: Chloroquine

First Posted Date: 2015-09-30

Last Posted Date: 2020-11-02

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 60

Registration Number: NCT02563496

Locations: 🇻🇳
GSK Investigational Site, Ho Chi Minh, Vietnam

Evaluation of Weekly Tafenoquine

Phase 2

Completed

Conditions: Malaria

Interventions: Other: Placebo
Drug: Tafenoquine

First Posted Date: 2015-07-08

Last Posted Date: 2018-09-13

Lead Sponsor: U.S. Army Medical Research and Development Command

Target Recruit Count: 249

Registration Number: NCT02491606

A Randomized, Double-blind, Placebo-controlled Evaluation of Increasing Doses of Weekly Tafenoquine for Chemosuppression of Plasmodium Falciparum

Phase 2

Completed

Conditions: Malaria

Interventions: Drug: Placebo
Drug: Tafenoquine 25mg
Drug: Tafenoquine 50mg
Drug: Tafenoquine 100 mg
Drug: Mefloquine 250 mg
Drug: Tafenoquine 200 mg

First Posted Date: 2015-07-02

Last Posted Date: 2018-09-13

Lead Sponsor: U.S. Army Medical Research and Development Command

Target Recruit Count: 521

Registration Number: NCT02488902

An Evaluation of Weekly Tafenoquine

Phase 2

Completed

Conditions: Falciparum Parasitaemia

Interventions: Drug: Placebo
Drug: Tafenoquine
Drug: Mefloquine

First Posted Date: 2015-07-02

Last Posted Date: 2017-05-30

Lead Sponsor: U.S. Army Medical Research and Development Command

Target Recruit Count: 306

Registration Number: NCT02488980

Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria

Phase 3

Completed

Conditions: Malaria, Vivax

Interventions: Drug: Tafenoquine Placebo
Drug: Tafenoquine
Drug: Chloroquine
Drug: Primaquine Placebo
Drug: Primaquine

First Posted Date: 2014-08-13

Last Posted Date: 2018-05-16

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 251

Registration Number: NCT02216123

Locations: 🇻🇳
GSK Investigational Site, Ho Chi Minh, Vietnam

A Study to Evaluate the Pharmacokinetics of a Single Dose of Tafenoquine Co-administered With Either Artemether + Lumefantrine or Dihydroartemisinin + Piperaquine Tetraphosphate

Phase 1

Completed

Conditions: Malaria, Vivax

Interventions: Drug: Tafenoquine
Drug: Dihydroartemisinin + Piperaquine tetraphosphate
Drug: Artemether + Lumefantrine

First Posted Date: 2014-07-09

Last Posted Date: 2017-07-13

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 120

Registration Number: NCT02184637

Locations: 🇺🇸
GSK Investigational Site, Baltimore, Maryland, United States

Tafenoquine Thorough QTc Study in Healthy Subjects

Phase 1

Completed

Conditions: Malaria, Vivax

Interventions: Drug: moxifloxacin
Drug: Tafenoquine 1200mg
Drug: Tafenoquine 300mg
Drug: Tafenoquine 600mg
Drug: Placebo for Tafenoquine
Drug: Placebo for moxifloxaxin

First Posted Date: 2013-08-27

Last Posted Date: 2017-06-12

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 260

Registration Number: NCT01928914

Locations: 🇺🇸
GSK Investigational Site, Baltimore, Maryland, United States

Ph 2B/3 Tafenoquine (TFQ) Study in Prevention of Vivax Relapse

Phase 2

Completed

Conditions: Malaria, Vivax

Interventions: Drug: Chloroquine 600mg (Part 2 )
Drug: Chloroquine 600mg
Drug: Chloroquine 300mg (Part 2 )
Drug: Chloroquine 300mg
Drug: Tafenoquine 600mg
Drug: Tafenoquine 300mg (Part 2)
Drug: Tafenoquine 50mg
Drug: Tafenoquine 100mg
Drug: Primaquine 15mg (Part2 )
Drug: Tafenoquine 300mg
Drug: Primaquine 15mg

First Posted Date: 2011-06-20

Last Posted Date: 2018-04-23

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 851

Registration Number: NCT01376167

Locations: 🇹🇭
GSK Investigational Site, Tak, Thailand

Study to Evaluate the Efficacy and Safety of Tafenoquine for the Treatment of Plasmodium Vivax in Adults

Phase 2

Terminated

Conditions: Malaria
Plasmodium Vivax

Interventions: Drug: Chloroquine + Primaquine
Drug: tafenoquine

First Posted Date: 2011-02-07

Last Posted Date: 2018-02-23

Lead Sponsor: U.S. Army Medical Research and Development Command

Target Recruit Count: 70

Registration Number: NCT01290601

Locations: 🇹🇭
Bangkok Hospital for Tropical Diseases/Mahidol University, Bangkok, Thailand

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy