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Ibuzatrelvir co-process API film coated

Phase 1

Coronavirus Disease 2019 | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Apr 27, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07552779A Study of How Ibuzatrelvir is Taken up Into the Blood of Healthy Adults After Taking Different Tablets of IbuzatrelvirPHASE1 RECRUITING 18Apr 13, 2026Jul 6, 2026Apr 27, 20261 Belgium
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Study Endpoints
Primary Endpoints
Plasma ibuzatrelvir AUCinf (as data permit, otherwise AUClast) in the fasted state
Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period

Relative bioavailability of a new oral formulation of ibuzatrelvir compared to the original tablet formulation in the fasted state

Plasma ibuzatrelvir Cmax in the fasted state
Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period

Relative bioavailability of a new oral formulation of ibuzatrelvir compared to the original tablet formulation in the fasted state

Secondary Endpoints
Incidence of AEs, clinical laboratory measurements, vital signs, and standard 12-lead ECGs
Day 1-35
Plasma ibuzatrelvir AUCinf (as data permit, otherwise AUClast)
Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period
Plasma ibuzatrelvir Cmax
Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Treatment AEXPERIMENTALsingle dose of ibuzatrelvir original tablet formulation in the fasted state on Day 1 of the treatment period
Treatment BEXPERIMENTALsingle dose of ibuzatrelvir new tablet formulation in the fasted state on Day 1 of the treatment period
Treatment CEXPERIMENTALsingle dose of ibuzatrelvir of the new tablet formulation dispersed in water and given in the fasted state on Day 1 of the treatment period
Treatment DEXPERIMENTALsingle dose of ibuzatrelvir new tablet formulation in the fed state on Day 1 of the treatment period
Interventions
NameTypeDescription
Ibuzatrelvir co-process API film coated tabletDRUGoriginal
Ibuzatrelvir filmcoated tabletDRUGnew
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: 1. 18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs. 2. BMI of 16-32 kg/m2; and a tot...

Countries:Belgium
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