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Krintafel

(Tafenoquine)

Phase 3Small molecule

GGlaxo Dba Glaxosmithkline

Tafenoquine is an antimalarial medication used in two ways: to prevent malaria from returning in people currently being treated with chloroquine or hydroxychloroquine, and to prevent malaria infection in travelers visiting areas where the disease is common. It works by killing the organisms that cause malaria.[1] Krintafel is currently being investigated across 5 indications[3], with its most advanced program in Phase 3.[1]

Krintafel is one of 54 small molecule programs targeting Malaria. It is currently in Phase 3.

5

Indications

31

Total Trials

6

Active Trials

53

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

4

Patents

Pipeline

Status by Indication[3][1]

Indication

MalariaActive, not recruiting

HemolysisActive, not recruiting

Plasmodium Vivax MalariaActive, not recruiting

COVID-19Active, not recruiting

BabesiosisActive, not recruiting

MalariaPhase 3

Active, not recruiting

HemolysisPhase 1

Active, not recruiting

Plasmodium Vivax MalariaPhase 3

Active, not recruiting

COVID-19Phase 2

Active, not recruiting

BabesiosisPhase 2

Active, not recruiting

Competition

Competitive Landscape

1932 competitors in COVID-19

#DrugCompanyPhaseTrials

Krintafel

GGlaxo Dba Glaxosmithkline

Biaxin

Singulair

Activella

Angiomax

BBaxter Healthcare Corporation

Nitrostat

VViatris Specialty LLC

Low-Molecular-Weight Heparin

Achromycin V

WWyeth-Lederle Vaccines

Orap

Calcium

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 1Not yet recruiting

Adult

NCT07373743

Phase 3Recruiting

Malaria

NCT06148792

Q3 2027

Phase 2Recruiting

Babesiosis

NCT06207370

Phase 2Recruiting

Babesiosis

NCT06656351

Q1 2028

Post-ApprovalRecruiting

Study completion

NCT04704999

Clinical

Trials by Indication[1]

Malaria4 trials

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

Completed· GSK logo

GSK·Phase 2·NCT02563496·60 enrolled

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

Recruiting· GSK logo

GSK·Phase 3·NCT06666491·300 enrolled

Efficacy and Safety Study of Tafenoquine (TQ) Co-administered With Dihydroartemisinin-piperaquine (DHA-PQP) for the Radical Cure of Plasmodium Vivax (P. Vivax) Malaria

Completed· GSK logo

GSK·Phase 3·NCT02802501·150 enrolled

Show 1 more trial

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

Recruiting·MMenzies School of Health Research·Phase 3·NCT06148792·1,090 enrolled

Babesiosis3 trials

B-FREE Chronic Babesiosis Study

Recruiting·660 Degrees Pharmaceuticals LLC·Phase 2·NCT06656351·40 enrolled

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

Recruiting·660 Degrees Pharmaceuticals LLC·Phase 2·NCT06207370·33 enrolled

Expanded Use in Persistent (B. Microti) Babesiosis

Available·660 Degrees Pharmaceuticals LLC··NCT06478641

Plasmodium vivax malaria1 trial

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

Completed· GSK logo

GSK·Phase 3·NCT02216123·251 enrolled

Efficacy1 trial

Gametocytocidal and Transmission-blocking Efficacy of PQ in Combination With AL and TQ in Combination With SPAQ in Mali

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 2·NCT05081089·80 enrolled

Effectiveness1 trial

Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine

Completed·MMenzies School of Health Research·Phase 3·NCT04411836·960 enrolled

13 more indications

Single Dose1 trial

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

Completed· GSK logo

GSK·Phase 1·NCT02184637·120 enrolled

Breast1 trial

Tafenoquine and Primaquine in Colostrum and Breast Milk

Withdrawn·UUniversity of Oxford·Phase 4·NCT04984759

TIA1 trial

Assessment of Any Potential Retinal Effects of Tafenoquine (TQ)

Completed· GSK logo

GSK·Phase 1·NCT02658435·486 enrolled

Adult1 trial

Pharmacokinetic (PK) Study of Tafenoquine in Healthy Adults

Not yet recruiting·SState University of New York - Upstate Medical University·Phase 1·NCT07373743·20 enrolled

ISS1 trial

Single Low Dose Tafenoquine to Reduce P. Falciparum Transmission in Mali (NECTAR2)

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 2·NCT04609098·80 enrolled

COVID-191 trial

Tafenoquine in Patients With Mild to Moderate COVID-19

Completed·660 Degrees Pharmaceuticals LLC·Phase 2·NCT04533347·86 enrolled

Prevention1 trial

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

Completed· GSK logo

GSK·Phase 2·NCT01376167·851 enrolled

Safety and Efficacy1 trial

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

Unknown status·660P Australia Pty Ltd·Phase 2·NCT05947812·148 enrolled

Plasmodium Falciparum1 trial

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

Completed·UU.S. Army Medical Research and Development Command·Phase 2·NCT02488902·521 enrolled

Oral1 trial

A Study to Assess the Effects of Dissolution Profile on the Pharmacokinetics of Single Oral Doses of Tafenoquine Tablets and Tafenoquine Stable Isotope Labelled Solution

Completed· GSK logo

GSK·Phase 1·NCT02751294·14 enrolled

Hemolysis1 trial

G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine)

Completed· GSK logo

GSK·Phase 1·NCT01205178·192 enrolled

Efficacy and Safety1 trial

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

Terminated·UU.S. Army Medical Research and Development Command·Phase 2·NCT01290601·70 enrolled

Unspecified9 trials

Southeast Asia Dose Optimization of Tafenoquine

Recruiting·UUniversity of Oxford·Phase 4·NCT04704999·700 enrolled

Evaluation of Weekly Tafenoquine

Completed·UU.S. Army Medical Research and Development Command·Phase 2·NCT02491606·249 enrolled

Operational Feasibility of Appropriate Radical Cure of Plasmodium Vivax With Tafenoquine or Primaquine After Quantitative G6PD Testing in Brazil

Unknown status·FFundação de Medicina Tropical Dr. Heitor Vieira Dourado··NCT05096702·16,000 enrolled

Show 6 more trials

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

Completed·—··NCT05753150·187 enrolled

Tafenoquine Thorough QTc Study in Healthy Subjects

Completed· GSK logo

GSK·Phase 1·NCT01928914·260 enrolled

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

Completed· Medicines for Malaria Venture logo

Medicines for Malaria Venture··NCT05361486·187 enrolled

An Evaluation of Weekly Tafenoquine

Completed·UU.S. Army Medical Research and Development Command·Phase 2·NCT02488980·306 enrolled

Vivax Elimination With Tafenoquine (VET) Study

Completed·SShoklo Malaria Research Unit·Phase 4·NCT06575647·1,242 enrolled

Long-Term Safety Study of Tafenoquine

Completed·660 Degrees Pharmaceuticals LLC·Phase 2·NCT03320174·600 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 20, 2018

KRINTAFEL

NDA NDA210795

Aug 8, 2018

ARAKODA

NDA NDA210607

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for Tafenoquine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tafenoquine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tafenoquine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA210607). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Krintafel. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Glaxo Dba Glaxosmithkline company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: GGlaxo Dba Glaxosmithkline

Patent Landscape[5]

Patent Cliff

Dec 2, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10342791Dec 2, 2035

11744828Dec 2, 2035

10888558Dec 2, 2035

12616689Dec 2, 2035

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