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Ibuzatrelvir co-process API film coated

Phase 1

Coronavirus Disease 2019 | Small molecule | Infectious Disease |Pfizer, Inc.|Trials Updated: Jul 28, 2026

Ibuzatrelvir co-process API film coated target and mechanism

ModalitySmall molecule

Also known as Ibuzatrelvir co-process API film coated tablet

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Ibuzatrelvir co-process API film coated clinical trials

Ibuzatrelvir co-process API film coated · 1 trial · 11 indications

Phase 1 1
NCT07552779A Study of How Ibuzatrelvir is Taken up Into the Blood of Healthy Adults After Taking Different Tablets of IbuzatrelvirCoronavirus Disease 2019
COMPLETED17 Analytics
PHASE1COMPLETED
A Study of How Ibuzatrelvir is Taken up Into the Blood of Healthy Adults After Taking Different Tablets of Ibuzatrelvir
Coronavirus Disease 2019Unlock trial analytics

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 to 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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Recent Changes (Last 90 Days)

MEDIUMAug 28, 2026NCT07552779TRIAL_REMOVED: changed
MEDIUMAug 28, 2026NCT07552779TRIAL_REMOVED: changed
MEDIUMAug 28, 2026NCT07552779TRIAL_REMOVED: changed
MEDIUMAug 28, 2026NCT07552779TRIAL_REMOVED: changed
HIGHJul 28, 2026NCT07552779Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJul 28, 2026NCT07552779Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about Ibuzatrelvir co-process API film coated

What is Ibuzatrelvir co-process API film coated?

Ibuzatrelvir co-process API film coated is an investigational small molecule antiviral tablet being developed by Pfizer, Inc. (PFE) for Coronavirus Disease 2019 (COVID-19). It is a film coated oral formulation of ibuzatrelvir, and it remains in clinical development rather than being an approved medicine.

What is Ibuzatrelvir co-process API film coated used for?

It is being studied for the treatment of Coronavirus Disease 2019 (COVID-19), an infectious disease. The clinical program has also listed related respiratory tract infections and pneumonia among the conditions studied. It is investigational, so it is not yet an approved treatment for any indication.

Who makes Ibuzatrelvir co-process API film coated?

Pfizer, Inc. is the developer of Ibuzatrelvir co-process API film coated. Pfizer trades on the New York Stock Exchange under the ticker PFE. The company is responsible for the clinical development of this oral antiviral candidate for COVID-19.

What phase is Ibuzatrelvir co-process API film coated in?

Ibuzatrelvir co-process API film coated is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any use.

What clinical trials is Ibuzatrelvir co-process API film coated in?

One Phase 1 trial of Ibuzatrelvir co-process API film coated has been completed: NCT07552779, titled A Study of How Ibuzatrelvir is Taken up Into the Blood of Healthy Adults After Taking Different Tablets of Ibuzatrelvir. It enrolled 17 healthy adult volunteers in Belgium and was a controlled, randomized study.

Is Ibuzatrelvir co-process API film coated the same as Ibuzatrelvir co-process API film coated tablet?

Yes. Ibuzatrelvir co-process API film coated tablet is another name for Ibuzatrelvir co-process API film coated. Both refer to the same Pfizer oral antiviral candidate being studied for Coronavirus Disease 2019 (COVID-19) in Phase 1 clinical development.