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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 08 Jan 2026

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At a glance

  • Drugs Tafenoquine (Primary)
  • Indications Babesiosis; Fatigue
  • Focus Therapeutic Use
  • Acronyms B-FREE study
  • Sponsors 60 Degrees Pharmaceuticals

Most Recent Events

  • 29 Dec 2025 According to a 60 Degrees Pharma media release, B-Free Study is now enrolling patients at the Icahn School of Medicine at Mount Sinai in New York and continues to evaluate the efficacy and safety of ARAKODA (tafenoquine) for the treatment of chronic babesiosis.
  • 21 Nov 2025 According to a 60 Degrees Pharma media release, the central study site for this B-FREE Chronic Babesiosis Study, the Cohen Center for Recovery from Complex Chronic Diseases at Mount Sinai Icahn School of Medicine, is open for patient enrollment. This study will run for approximately 12 months.
  • 09 Oct 2025 Planned number of patients changed from 40 to 100.

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