Recruiting
Phase 2

Tafenoquine

Sponsor:

60 Degrees Pharmaceuticals LLC

Code:

NCT06656351

Conditions

Chronic Babesiosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tafenoquine 100mg

Study Details

Brief summary:

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

Conditions

Chronic Babesiosis

Study ID

NCT06656351

Start date

Nov 18, 2025

Status verified date

Nov, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tafenoquine

Tafenoquine (2 x 100 mg tablets) will be self-administered orally with food on Days 1, 2, 3, 4, then weekly thereafter for a total 12-week treatment period. Weekly treatment will start on Day 11 and end on Day 89.

Interventions

Tafenoquine 100mg

Tafenoquine

Primary outcome measure

  • Change in General Fatigue [ Time Frame: From enrollment until Day 90 of treatment. ]

Central Contacts and Locations

Central contacts

Core Research

212-241-7658CoreResearch@mountsinai.org

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

David Putrino, PhD

More Information

Sponsor

60 Degrees Pharmaceuticals LLC

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Keywords

  • Chronic Babesiosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by 60 Degrees Pharmaceuticals LLC on 2025-11-21.