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PF-07985631

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 20, 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-BlindCONTROLLEDBiomarker
Total Trials2
Total Enrollment168
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07235150A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body in Healthy AdultsPHASE1 RECRUITING 76Dec 11, 2025Aug 24, 2027Mar 19, 20261 Australia
NCT06994897A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy AdultsPHASE1 RECRUITING 92Aug 13, 2025Dec 8, 2027Mar 20, 20261 Belgium
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)
Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)
Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria
Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)
Number of Participants With Notable Electrocardiogram (ECG) Values
Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)
Secondary Endpoints
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) as data permit
Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) as data permit
Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)
Maximum Observed Plasma Concentration (Cmax) as data permit
Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort 1 Dose A (3 active: 2 placebo)EXPERIMENTALDrug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be subcutaneous (SC)
Cohort 2 Dose B (3 active: 2 placebo)EXPERIMENTALDrug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC
Cohort 3 Dose C (6 active: 2 placebo)EXPERIMENTALDrug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC
Cohort 4 Dose D (6 active: 2 placebo)EXPERIMENTALDrug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC
Cohort 5 Dose E (6 active: 2 placebo)EXPERIMENTALDrug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC
Cohort 6 Dose F (6 active: 2 placebo)EXPERIMENTALDrug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC
Cohort 7 Dose G (6 active: 2 placebo)EXPERIMENTALDrug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC
Cohort 8 Optional Cohort with dose to be determined, Japanese (4 active: 1 placebo)EXPERIMENTALDrug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC
Cohort 9 Optional Cohort with dose to be determined, Chinese (4 active: 1 placebo)EXPERIMENTALDrug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC
Cohort 10 Optional Cohort with dose to be determined (6 active: 2 placebo)EXPERIMENTALDrug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC
Cohort 11 Optional Cohort with dose to be determined (6 active: 2 placebo)EXPERIMENTALDrug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC
Cohort 1: single ascending doseEXPERIMENTALDose A (3 active: 2 placebo)
Cohort 2: single ascending doseEXPERIMENTALDose B (3 active: 2 placebo)
Cohort 3: single ascending doseEXPERIMENTALDose C (6 active: 2 placebo)
Cohort 4: single ascending doseEXPERIMENTALDose D (6 active: 2 placebo)
Cohort 5: single ascending doseEXPERIMENTALOptional Cohort with dose to be determined (6 active: 2 placebo)
Cohort 6: single ascending doseEXPERIMENTALOptional Cohort with dose to be determined (6 active: 2 placebo)
Cohort 7: single ascending doseEXPERIMENTALOptional Cohort with dose to be determined (6 active: 2 placebo)
Cohort 8: single doseEXPERIMENTALOptional Japanese Cohort dose to be determined (4 active: 1 placebo)
Cohort 9: single doseEXPERIMENTALOptional Chinese Cohort dose to be determined (4 active: 1 placebo)
Cohort 10: multiple doseEXPERIMENTALOptional Cohort with dose to be determined (6 active: 2 placebo)
Cohort 11EXPERIMENTALOptional Cohort with dose to be determined (6 active: 2 placebo)
Cohort 12EXPERIMENTALOptional Cohort with dose to be determined (6 active: 2 placebo)
Cohort 13EXPERIMENTALOptional Cohort with dose to be determined (6 active: 2 placebo)
Interventions
NameTypeDescription
PF-07985631DRUGExperimental Pfizer compound which will be SC
PlaceboDRUGPlacebo which will be SC
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion: 1. Between 18 and 45 years of age who are overtly healthy. 2. Japanese/Chinese cohorts only: Adult participants 18 to 55 years of age 3. Japanese/Chinese cohorts only: Participants must have 4 biological Japanese/Chinese grandparents who were born in Japan/China. Exclusion: 1. Evidence...

Countries:AustraliaBelgium
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06994897primaryCompletionDate: changed
LOWMay 26, 2026NCT07235150primaryCompletionDate: changed
LOWMay 24, 2026NCT06994897studyFirstPostDate: changed
LOWMay 24, 2026NCT07235150studyFirstPostDate: changed