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Baloxavir

Phase 3

Influenza A | Small molecule | Infectious Disease |Unity Biotechnology, Inc.|Last Updated: Jan 2, 2026

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 Enrollment264
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07314905Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp)PHASE3 NOT YET_RECRUITING 264Jan 2, 2026Apr 24, 2027Jan 2, 20261 Canada
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Study Endpoints
Primary Endpoints
time to recovery (defined as the first instance that a participant report feeling fully recovered)
Day 1 to Day 28

The primary outcome is time to recovery (defined as the first instance that a participant report feeling fully recovered)

Secondary Endpoints
All-cause emergency department (ED) visits
Day 1 to Day 28
All-cause hospitalization visits
Day 1 to Day 28
All-cause death
Day 1 to Day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Acute Influenza A/B - Matched placebo for BaloxavirPLACEBO_COMPARATORUsual Care (i.e., supportive care and symptom relief). Matching control placebo for Baloxavir - a single matching dose.
Acute Influenza A/B - BaloxavirEXPERIMENTALThe adaptative platform trial will assess therapeutics for influenza A/B in out-patient setting. Interventions include: Baloxavir. Baloxavir dose: if weight \<80 kg: one 40 mg dose for 1 day; if weight ≥80kg, one 80 mg dose for one day.
Interventions
NameTypeDescription
BaloxavirDRUGThis is a sub-protocol within the TreatResp adaptive platform trial to compare the clinical and cost-effectiveness of Baloxavir, a single 40mg or 80 mg tablet based on patient weight, to a matching placebo among non-hospitalized patients with mild to moderate influenza A/B. This sub-protocol is part of the influenza domain within TreatResp.
Placebo ControlDRUGMatching placebo for Baloxavir
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 18 years or older * A positive test (PCR or RAT) for one of the pathogens included in the trial's domains (influenza A/B, or other future specified respiratory pathogens), * Enrolled within 5 days of symptoms onset. However, this window may vary depending on the domain or spec...

Countries:Canada
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07314905primaryCompletionDate: changed
LOWMay 24, 2026NCT07314905studyFirstPostDate: changed