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Tafenoquine

Phase 2

COVID 19 Disease | Small molecule | Infectious Disease |60 Degrees Pharmaceuticals, Inc.|Last Updated: Jan 7, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment86
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04533347Tafenoquine in Patients With Mild to Moderate COVID-19PHASE2 COMPLETED 86Feb 19, 2021Jun 30, 2022Jan 7, 202510 United States
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Study Endpoints
Primary Endpoints
Number of Patients With Clinical Recovery of COVID-19 Symptoms on Day 14
Day 14 [± 1 day]

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.

Secondary Endpoints
Increases the Proportion of Patients With Absence of Clinical Symptoms by Individual Symptom at Day 14
Day 14 [± 1 day]
Decreases the Hospitalization Rate Due to COVID-19 by Day 14
Day 14 [± 1 day]
Decreases the Number of Medical Follow-up Visits by Day 14.
Day 14 [± 1 day]
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TafenoquineACTIVE_COMPARATORTafenoquine two 100 mg oral tablets 1x/day on Days 1,2,3 and 10
PlaceboPLACEBO_COMPARATORPlacebo two tablets 1x/day on Days 1,2,3 and 10
Interventions
NameTypeDescription
Tafenoquine Oral TabletDRUGPatients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.
PlaceboDRUGPatients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Male or female, aged ≥18 years of age; * Laboratory confirmed infection with COVID-19 virus by an FDA-authorized SARS-Cov-2 RT-PCR; * Able and willing to give written informed consent. * Willing to keep an electronic diary from Study Day 1 to Study Day 13 (± 1 day) and Study D...

Countries:United States
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