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PF-07328948

Phase 1

Hepatic Impairment | Small molecule | Gastrointestinal |Pfizer, Inc.|Last Updated: May 26, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07269301A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver FunctionPHASE1 RECRUITING 26Dec 22, 2025Feb 23, 2027May 26, 20263 United States
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Study Endpoints
Primary Endpoints
Fraction of Unbound Drug in Plasma (Fu) of PF-07328948
At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post dose on Day 1

Fu is the fraction of unbound drug in plasma, which is calculated by Cu/C (where Cu represents unbound concentration and C represents total concentration).

Unbound AUCinf (AUCinf,u) of PF-07328948
At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post dose on Day 1

AUCinf is the area under the plasma concentration-time profile from time zero extrapolated to infinite time. AUCinf,u is the unbound AUCinf.

Unbound Cmax (Cmax,u) of PF-07328948
At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post dose on Day 1

Cmax is the maximum plasma concentration. Cmax,u is the unbound Cmax.

Secondary Endpoints
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Day 1 to Day 36
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Group 1: PF-07328948 participants with severe hepatic impairmentEXPERIMENTALParticipants with severe hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.
Group 2: PF-07328948 participants with moderate hepatic impairmentEXPERIMENTALParticipants with moderate hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.
Group 3: PF-07328948 participants with mild hepatic impairmentEXPERIMENTALParticipants with mild hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.
Group 4: PF-07328948 participants without hepatic impairmentEXPERIMENTALParticipants without hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.
Interventions
NameTypeDescription
PF-07328948DRUGPF-07328948, 1 tablet orally, once on Day 1
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Eligibility Criteria
Age Range18 Years — 74 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Male or female of nonchildbearing potential, between the ages of 18 (inclusive) and 75 years, at the screening visit. * Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * BMI of 17.5 t...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 27, 2026NCT07269301startDate: changed
LOWMay 27, 2026NCT07269301startDate: changed
LOWMay 26, 2026NCT07269301primaryCompletionDate: changed
LOWMay 24, 2026NCT07269301studyFirstPostDate: changed