Tafenoquine treatment for chronic babesiosis with severe fatigue
Official title: B-FREE Chronic Babesiosis Study: A Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients With Severe Fatigue
Run by 60 Degrees Pharmaceuticals LLC · NCT06656351 · Data updated 2026-11-12
This open-label Phase 2 trial tests tafenoquine 100 mg to see if it reduces severe fatigue and other symptoms in adults with chronic babesiosis who have laboratory evidence of recent Babesia exposure.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | 60 Degrees Pharmaceuticals LLC Industry-sponsored |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | November 18, 2025 |
| Main results expected | February 2027 |
| Study ends | September 2027 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT06656351 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 or older with chronic babesiosis who have severe disabling fatigue, at least one common babesiosis symptom, laboratory evidence of Babesia exposure within the past 12 months, and no G6PD deficiency are the intended participants.
✕Probably not a fit
People with G6PD deficiency, breastfeeding individuals, those with unmanaged psychotic disorders, active chronic viral infections, current quinine treatment, or other significant uncontrolled illnesses are unlikely to be eligible or to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 open-label study gives tafenoquine 100 mg to adults with chronic babesiosis who experience severe disabling fatigue and have laboratory evidence of Babesia exposure within the last 12 months. Participants receive oral tafenoquine and undergo regular clinical and laboratory assessments to monitor symptoms and safety. Key exclusions include G6PD deficiency, breastfeeding, unmanaged psychotic disorders, known hypersensitivity to 8‑aminoquinolines, current or planned quinine therapy, and active chronic viral infections. The study is sponsored by 60 Degrees Pharmaceuticals and conducted at the Icahn School of Medicine at Mount Sinai in New York City.
Why it matters
Potential benefit: If successful, tafenoquine could reduce persistent fatigue and other symptoms and provide an effective oral option for people with chronic babesiosis.
How similar studies have gone: Use of tafenoquine for babesiosis is relatively novel with limited clinical data beyond case reports and extrapolation from its approved use against malaria.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female, aged ≥ 18 years * Severe disabling fatigue * Have at least one common symptom of babesiosis * Have laboratory evidence of exposure to babesia in the last 12 months * Able and willing to give written informed consent * Able and willing to perform all study assessments * If female negative urine pregnancy test and * If female agree to use an acceptable method of birth control Exclusion Criteria: * Glucose-6-phosphate-dehydrogenase (G6PD) deficiency * Breastfeeding * Unmanaged Psychotic disorder * Known hypersensitivity reaction to tafenoquine or other 8-aminoquinolines * Current or planned treatment with quinine * Uncontrolled cardiopulmonary or endocrine disorders * Taking OCT2/MATE substrates without appropriate medical oversight * Medical history of chronic, active viral diseases including HIV/AIDS, hepatitis B, and hepatitis C * Have a risk factors for relapsing babesiosis * Anorexia * Any concomitant significant illness unrelated to babesiosis * The patient is unable to tolerate medication by the oral route * The patient has previously taken tafenoquine * Hemoglobin at baseline is ≤ 8 g/dL
Where it's running
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Icahn School of Medicine at Mount Sinai
New York, New York, United States Recruiting
Study contacts
- Study coordinator: Core Research
- Email: CoreResearch@mountsinai.org
- Phone: 212-241-7658
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.