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PF-07941944

Phase 1

Healthy Participants | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 17, 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
RandomizedCONTROLLED
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06920498A Study to Learn How Different Amounts of the Study Medicine Called PF-07941944 Are Tolerated in the Body of Healthy Adults.PHASE1 COMPLETED 25 — — Dec 3, 2024Jun 19, 2025Jul 17, 20251 Belgium
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Baseline through end of study, approximately 16 weeks

Part 1 and Part 2

Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Baseline through end of study, approximately 16 weeks

Part 1 and Part 2

Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Baseline through end of study, approximately 16 weeks

Part 1 and Part 2

Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
Baseline through end of study, approximately 16 weeks

Part 1 and Part 2

Maximum Observed Plasma Concentration (Cmax)
Baseline through end of study, approximately 16 weeks

Part 3

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Baseline through end of study, approximately 16 weeks

Part 3 - if data permit

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Baseline through end of study, approximately 16 weeks

Part 3 - If AUCinf not collected

Secondary Endpoints
Cmax
Baseline through end of study, approximately 16 weeks
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Baseline through end of study, approximately 16 weeks
AUClast
Baseline through end of study, approximately 16 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part 1EXPERIMENTALSingle ascending dose of PF-07941944 or placebo in healthy adult participants
Part 2EXPERIMENTALMultiple doses of PF-07941944 or placebo in healthy adult participants
Part 3 (Optional)EXPERIMENTALPeriod 1, single dose of Midazolam. Period 2, multiple doses of PF-07941944 + Midazolam
Interventions
NameTypeDescription
PF-07941944DRUGOral formulation
PlaceboDRUGOral formulation
MidazolamDRUGOral formulation
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation * Body mass index (BMI) of 17.5 to 30.5 kg/m2 * For inclusion of Japanese participants: participants who have 4 Japanese biologic grandparents who were born in Japan. Exclusion Criteria: * Evidence or h...

Countries:Belgium
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