Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication KRINTAFEL is indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving chloroquine therapy for acute P. vivax infection [see Dosage and Administration ( 2.2 )] . Limitations of Use • KRINTAFEL is NOT indicated for the treatment of acute P. vivax malaria. FDA label
Also known as Tafenoquine Oral Tablet
Tafenoquine · 3 trials · 3 indications
The Multidimensional Fatigue Inventory (MFI) is a 20-item, patient-reported scale. designed to evaluate five dimensions of fatigue: general fatigue (items 1, 5, 12, 16), physical fatigue (items (items 2, 8, 14, 20), reduced motivation (items 3, 6, 10, 17), reduced activity (items 4, 9, 15, 18), and mental fatigue (items 7, 11, 13, 19) (Smets-1995). Items are scored 1-5, with 10 positively phrased items reverse scored (items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). This scale has been used to assess treatment outcomes in patients with chronic fatigue syndrome, women with fibromyalgia, Parkinson's disease, patients undergoing anti-cancer treatment, and the impact of fatigue on the quality of life in rheumatoid arthritis. Total scale score, and each of the 5 subscales scores will be calculated. MFI subscales are scored by summing four items, each has five possible responses giving a range of possible scores from 4 to 20.
Time to sustained clinical resolution of all the following symptoms of babesiosis: sweats, joint aches, cough, loss of appetite, muscle aches, headache, chills or shivering, feeling hot or feverish, nausea, fatigue (low energy or tiredness), and vomiting. The time to achieve sustained clinical resolution will be the date when patients first self-report a 7-day period without these symptoms relative to the start of tafenoquine or placebo treatment.
Clinical recovery from COVID-19 symptoms was defined as: temperature \< or equal to 37.7 degrees Celsius (surface by infra-red or oral), respiratory rate \< or equal to 24/minute on room air, shortness of breath is absent on a patient-report scale, and cough is mild or absent on a patient-reported scale.
| Arm | Type | Description |
|---|---|---|
| Tafenoquine | EXPERIMENTAL | 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. |
| Group 1 | ACTIVE_COMPARATOR | TQ: 2 x 100 mg TQ tablets orally on Days 1, 2, 3, and 4 |
| Group 2 | PLACEBO_COMPARATOR | Placebo: 2 x 100 mg placebo tablets orally on Days 1, 2, 3, and 4 |
| Placebo | PLACEBO_COMPARATOR | Placebo two tablets 1x/day on Days 1,2,3 and 10 |
| Name | Type | Description |
|---|---|---|
| Tafenoquine 100mg | DRUG | Tafenoquine |
| Tafenoquine | DRUG | Oral Tafenoquine |
| Placebo | OTHER | Placebo |
| Tafenoquine Oral Tablet | DRUG | Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10. |
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 asses...
Tafenoquine is an oral small molecule being studied for chronic babesiosis, babesiosis, and COVID-19 disease. It is in Phase 2 clinical development and is not approved for these uses. The babesiosis programs are being run by 60 Degrees Pharmaceuticals, Inc. under the ticker SXTP.
Tafenoquine is being developed by 60 Degrees Pharmaceuticals, Inc., which trades under the ticker SXTP. The company is running the clinical programs evaluating the drug in babesiosis, chronic babesiosis, and COVID-19 disease.
Tafenoquine is in Phase 2 clinical development for babesiosis, chronic babesiosis, and COVID-19 disease. It is investigational and has not been approved by the FDA for these indications. The FDA has granted it orphan drug designation.
Tafenoquine is being studied in three Phase 2 trials. NCT06656351 is the B-FREE chronic babesiosis study, and NCT06207370 tests oral tafenoquine plus standard of care versus placebo plus standard of care in babesiosis. Both are recruiting in the United States. NCT04533347, in mild to moderate COVID-19, is completed.
Yes. Tafenoquine oral tablet and tafenoquine 100mg are alternative names for the same drug, tafenoquine. Searches using those terms refer to the oral small molecule developed by 60 Degrees Pharmaceuticals, Inc. for babesiosis, chronic babesiosis, and COVID-19 disease.
Tafenoquine is given as an oral tablet in its clinical trials. The Phase 2 babesiosis study NCT06207370 evaluates oral tafenoquine plus standard of care against placebo plus standard of care, and the chronic babesiosis study NCT06656351 also uses the oral formulation in adults 18 years and older.