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PF-08049820

Phase 2

Atopic Dermatitis | Small molecule | Immunology |Pfizer, Inc.|Last Updated: May 27, 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-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment181
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07216027A Study to Learn About Study Medicine Called PF-08049820 in People With EczemaPHASE2 RECRUITING 165 — — Nov 20, 2025Feb 2, 2028May 27, 202610 United States, Japan
NCT07190430A Study to Learn If the Study Medicine Called PF-08049820 Changes How the Body Processes the Other Study Medicines Called Oral Contraceptives, Midazolam, and Dabigatran in Healthy Adult Female ParticipantsPHASE1 ACTIVE NOT_RECRUITING 16 — — Oct 3, 2025Dec 15, 2025Dec 9, 20251 United States
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Study Endpoints
Primary Endpoints
Percent change from baseline in Eczema Area and Severity Index (EASI) total score at Week 12
Week 12
Pharmacokinetics (PK): Area Under the curve (AUC) of Midazolam
From pre-dose up to 24 hours post dose in Periods 1 and 4
PK: Plasma Maximum Concentration (Cmax) of Midazolam
From pre-dose up to 24 hours post dose in Periods 1 and 4
PK: Area Under the curve (AUC) of dabigatran
From pre-dose up to 48 hours post dose in Periods 2 and 5
PK: Cmax of dabigatran
From pre-dose up to 48 hours post dose in Periods 2 and 5
PK: AUC of Ethinyl estradiol and levonorgestrel
From pre-dose up to 96 hours post dose in Periods 3 and 6
PK: Cmax of Ethinyl estradiol and levonorgestrel
From pre-dose up to 96 hours post dose in Periods 3 and 6
Secondary Endpoints
Response based on achieving EASI75 (≥75% improvement from baseline) at scheduled time points
Day 1 through Week 16
Percent change from baseline in EASI total score at scheduled time points other than Week 12
Day 1 through Week 16
Response based on achieving Validated Investigator's Global Assessment (vIGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of >2 points at scheduled time points
Day 1 through Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTALStages 1 and 2: Tablets taken by mouth daily for 12 weeks
Arm 2EXPERIMENTALStages 1 and 2: Tablets taken by mouth daily for 12 weeks
Arm 3EXPERIMENTALStages 1 and 2: Tablets taken by mouth daily for 12 weeks
Arm 4PLACEBO_COMPARATORStages 1 and 2: Tablets taken by mouth daily for 12 weeks
Baseline MidazolamOTHERParticipants will receive a single dose of 2 mg midazolam in the morning on Day 1
Baseline dabigatran etexilateOTHERParticipants will receive a single dose of 150 mg dabigatran etexilate in the morning on Day 1
Baseline oral contraceptivesOTHERParticipants will receive a single dose of Portia (30 mcg of ethinyl estradiol (EE) and 150 mcg of levonorgestrel (LN)) or equivalent oral tablet in the morning on Day 1
Drug Drug Interaction (DDI) midazolamEXPERIMENTALParticipants will receive a single dose of 2 mg midazolam in the morning on Days 2 and 10 only with PF-08049820 Days 1 to 10
DDI dabigatran etexilateEXPERIMENTALParticipants will receive a single dose of 150 mg dabigatran etexilate in the morning on Day 1 only with PF-08049820 Days 1 to 2
DDI oral contraceptivesEXPERIMENTALParticipants will receive a single dose of Portia (30 mcg of EE and 150 mcg of LN) or equivalent oral tablet in the morning on Day 1 only with PF-08049820 on Days 1 to 2
Interventions
NameTypeDescription
PF-08049820DRUGTablet
PlaceboDRUGTablet
MidazolamDRUGAdministered orally
Dabigatran EtexilateDRUGAdministered orally
Portia (EE and LN) or equivalent oral tabletDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: Participants must meet the following criteria: 1. Are 18 years of age or older 2. Have clinical diagnosis of AD for at least 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs 3. Have moderate to severe AD as defined by the following at screening and base...

Countries:United StatesJapan
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Competitive Landscape -Atopic Dermatitis 82 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY6PHASE3Baricitinib, corticosteroid, Lebrikizumab, Corticosteroid
AbbVie, Inc.ABBV10PHASE3Upadacitinib, corticosteroids, Dupilumab, Upadacitinib Dose, Dupilumab Dose
Pfizer Inc.PFE12PHASE3Abrocitinib, PF-08049820, PF-07275315, PF-07264660, Midazolam
Sanofi SA Sponsored ADRSNY13PHASE3Amlitelimab, corticosteroids, tacrolimus or pimecrolimus, calcineurin inhibitors, Dupilumab SAR231893
Regeneron Pharmaceuticals, Inc.REGN4PHASE3Dupilumab, REGN20423, dupilumab
Incyte CorporationINCY3PHASE3Ruxolitinib, Vehicle, TCS
Amgen Inc.AMGN1PHASE3Rocatinlimab
Organon & Co.OGN1PHASE3Tapinarof , 1%, Vehicle
Novartis AG Sponsored ADRNVS2PHASE2GIA632, GHZ339
Apogee Therapeutics, Inc.APGE3PHASE2APG777, APG990, Dupilumab
Johnson & JohnsonJNJ1PHASE2JNJ-95597528
Kymera Therapeutics, Inc.KYMR1PHASE2KT-621
Nektar TherapeuticsNKTR1PHASE2Rezpegaldesleukin
Corvus Pharmaceuticals, Inc.CRVS1PHASE2Soquelitinib
Celldex Therapeutics, Inc.CLDX1PHASE2Barzolvolimab
Evommune, Inc.EVMN1PHASE2EVO756
Aclaris Therapeutics, Inc.ACRS1PHASE2ATI-045
Q32 Bio IncQTTB1PHASE2ADX-914
Turn Therapeutics Inc.TTRX1PHASE2GX-03
Arcutis Biotherapeutics IncARQT1PHASE1ARQ-234
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Recent Changes (Last 90 Days)
MEDIUMMay 28, 2026NCT07216027Status: ACTIVE_NOT_RECRUITING → RECRUITING
MEDIUMMay 28, 2026NCT07216027Status: ACTIVE_NOT_RECRUITING → RECRUITING
LOWMay 26, 2026NCT07190430primaryCompletionDate: changed
LOWMay 26, 2026NCT07216027primaryCompletionDate: changed
LOWMay 24, 2026NCT07190430studyFirstPostDate: changed
LOWMay 24, 2026NCT07216027studyFirstPostDate: changed