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

An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older

Phase 3

Recruiting

Conditions: Malaria, Vivax

Interventions: Drug: Tafenoquine
Drug: Primaquine
Drug: Chloroquine

First Posted Date: 2024-10-30

Last Posted Date: 2024-12-13

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 300

Registration Number: NCT06666491

Locations: 🇮🇳
GSK Investigational Site, Surat, India

Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue

Phase 2

Not yet recruiting

Conditions: Chronic Babesiosis

Interventions: Drug: Tafenoquine 100mg

First Posted Date: 2024-10-24

Last Posted Date: 2024-10-24

Lead Sponsor: 60 Degrees Pharmaceuticals LLC

Target Recruit Count: 40

Registration Number: NCT06656351

Vivax Elimination With Tafenoquine (VET) Study

Phase 4

Active, not recruiting

Conditions: Malaria, Vivax
Plasmodium Vivax
Plasmodium Vivax Malaria
Malaria

Interventions: Drug: Tafenoquine

First Posted Date: 2024-08-28

Last Posted Date: 2025-05-16

Lead Sponsor: Shoklo Malaria Research Unit

Target Recruit Count: 1000

Registration Number: NCT06575647

Locations: 🇹🇭
Shoklo Malaria Research Unit (SMRU), Mae Sot, Tak Province, Thailand

Expanded Use in Persistent (B. Microti) Babesiosis

Conditions: Persistent Babesiosis

First Posted Date: 2024-06-27

Last Posted Date: 2024-06-27

Lead Sponsor: 60 Degrees Pharmaceuticals LLC

Registration Number: NCT06478641

Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis

Phase 2

Recruiting

Conditions: Babesiosis

Interventions: Other: Placebo
Drug: Tafenoquine

First Posted Date: 2024-01-17

Last Posted Date: 2024-06-20

Lead Sponsor: 60 Degrees Pharmaceuticals LLC

Target Recruit Count: 33

Registration Number: NCT06207370

Locations: 🇺🇸
Tufts Medical Center, Boston, Massachusetts, United States

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

Phase 3

Recruiting

Conditions: Vivax Malaria

Interventions: Drug: Tafenoquine
Drug: Primaquine

First Posted Date: 2023-11-28

Last Posted Date: 2025-04-18

Lead Sponsor: Menzies School of Health Research

Target Recruit Count: 1090

Registration Number: NCT06148792

Locations: 🇧🇷
Dr Marcus Lacerda, Manaus, Brazil
🇪🇹
Arba Minch General Hospital, Arba Minch, Ethiopia
🇮🇩
Dr Rini Poespoprodjo, Timika, Indonesia

and more 1 locations

A Clinical Evaluation of the Safety and Efficacy of Randomized Placebo Versus the 8-aminoquinoline Tafenoquine for Early Symptom Resolution in Patients With Mild to Moderate COVID 19 Disease and Low Risk of Disease Progression

Phase 2

Not yet recruiting

Conditions: SARS-CoV-2
Severe Acute Respiratory Syndrome Coronavirus 2
COVID 19 Disease
Mild to Moderate COVID 19 Disease
Infectious Disease

Interventions: Drug: Tafenoquine Oral Tablet
Drug: Placebo

First Posted Date: 2023-07-17

Last Posted Date: 2023-07-17

Lead Sponsor: 60P Australia Pty Ltd

Target Recruit Count: 148

Registration Number: NCT05947812

Operational Feasibility of Appropriate Plasmodium Vivax Radical Cure After G6PD Testing in Thailand

Completed

Conditions: Malaria, Vivax
G6PD Deficiency

Interventions: Drug: Tafenoquine
Drug: Primaquine

First Posted Date: 2023-03-03

Last Posted Date: 2023-10-26

Lead Sponsor: Dr. Prayuth Sudathip

Target Recruit Count: 187

Registration Number: NCT05753150

Locations: 🇹🇭
Malaria Clinic, Than To, Yala, Thailand
🇹🇭
District Hospital, Than To, Yala, Thailand

Radical Cure (RC) With Tafenoquine or Primaquine After Semi-quantitative G6PD Testing: A Feasibility Study in Peru

Recruiting

Conditions: Malaria, Vivax

Interventions: Diagnostic Test: G6PD testing
Other: Training on revised algorithm
Drug: Tafenoquine
Other: Enhancing Pharmacovigilance
Other: Supervision of malaria services in selected facilities.
Drug: Primaquine
Other: Follow Up Visit at Day 3 [+2 days] after treatment start