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Tafenoquine - GlaxoSmithKline/60 Degrees Pharmaceuticals

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Drug Profile

Tafenoquine - GlaxoSmithKline/60 Degrees Pharmaceuticals

Alternative Names: 60P 003; Arakoda; Etaquine; KODATEF; Kozenis; Krintafel; SB-252263; SB-252263-AAB; SB-252263-AX; Tafenoquine maleate; Tafenoquine succinate; WR 238605; WR 238605 succinate

Latest Information Update: 17 Dec 2025

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At a glance

  • Originator Walter Reed Army Institute of Research
  • Developer 60 Degrees Pharmaceuticals; Biocelect; GlaxoSmithKline; GSK; Medicines for Malaria Venture
  • Class Aminoquinolines; Antifungals; Antimalarials; Antiprotozoals; Antivirals; Ethers; Fluorinated hydrocarbons; Small molecules
  • Mechanism of Action Electron transport complex III inhibitors; Reactive oxygen species stimulants; Virus replication inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Babesiosis
  • New Molecular Entity Yes
  • Available For Licensing Yes - COVID 2019 infections

Highest Development Phases

  • Marketed Malaria
  • Phase II Babesiosis; COVID 2019 infections
  • Preclinical Mycoses
  • Discontinued Pneumocystis pneumonia

Most Recent Events

  • 11 Dec 2025 US FDA rejects company’s request for Breakthrough Therapy Designation for ARAKODA and suggested to resubmit its request for babesiosis treatment
  • 18 Nov 2025 60 Degrees Pharmaceuticals initiates enrolment in the phase-II B-FREE trial for Babesiosis in USA (PO) (NCT06656351)
  • 15 Oct 2025 60 Degrees Pharmaceuticals plans a Type B meeting with US FDA for sNDA for Babesiosis in early 2026

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