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PF-07868489

Phase 1

Pulmonary Arterial Hypertension | Small molecule | Cardiovascular |Pfizer, Inc.|Last Updated: May 19, 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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment97
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06137742A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial HypertensionPHASE1 ACTIVE NOT_RECRUITING 97 — — Nov 17, 2023Sep 2, 2026May 19, 202668 United States, Australia +12
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Study Endpoints
Primary Endpoints
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline up to Day 113.

Part A

Number of Participants With Change From Baseline in Laboratory Tests Results
Baseline up to Day 113

Part A

Number of Participants With Vital Sign Abnormalities
Baseline up to Day 113

Part A

Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters
Baseline up to Day 113

Part A

Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week24
Baseline, Week 24

repeated doses

Secondary Endpoints
Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
Maximum Observed Plasma Concentration (Cmax)
Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-07868489EXPERIMENTALsingle subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)
PlaceboPLACEBO_COMPARATORsingle subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)
Interventions
NameTypeDescription
PF-07868489DRUGExperimental Treatment
Placebo for PF-07868489DRUGPlacebo
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites68

Key Inclusion Criteria Part A: * overtly healthy * Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight \>50 kg. Key Exclusion Criteria Part A: * clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, in...

Countries:United StatesAustraliaBelgiumCanadaChinaCzechiaFranceGermanyGreeceItalyJapanSouth KoreaSpainUnited Kingdom
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Competitive Landscape -Pulmonary Arterial Hypertension 40 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK6PHASE3Riociguat, Sotatercept, Frespaciguat, Background PAH Therapy
United Therapeutics CorporationUTHR5PHASE3Ralinepag, treprostinil
Insmed IncorporatedINSM4PHASE3Treprostinil Palmitil
Johnson & JohnsonJNJ4PHASE3Selexipag, Macitentan, selexipag
Liquidia CorporationLQDA4PHASE3L606, LIQ861 Treprostinil, LIQ861
Tenax Therapeutics, Inc.TENX3PHASE3TNX-103
Gossamer Bio, Inc.GOSS2PHASE3Seralutinib, GB002
Inhibikase Therapeutics, Inc.IKT1PHASE3IKT-001
Regeneron Pharmaceuticals, Inc.REGN1PHASE2REGN13335
Pfizer Inc.PFE2PHASE2PF-07868489
Tectonic Therapeutic IncTECX1PHASE2TX000045- Dose A, TX000045- Dose B
Abbott LaboratoriesABT1NAUndisclosed
Third Pole Therapeutics, Inc.THRD1NAUndisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06137742Enrollment: 96 → 97
LOWMay 24, 2026NCT06137742studyFirstPostDate: changed