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PF-08049820 MR1

Phase 1

Atopic Dermatitis | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Nov 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 Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07172321A Study to Learn How Different Forms of the Study Medicine Called PF 08049820 Are Taken up Into the Bloodstream in Healthy AdultsPHASE1 COMPLETED 12 — — Sep 5, 2025Oct 29, 2025Nov 17, 20251 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics (PK): Plasma Area Under the Concentration Versus Time Curve (AUC) of PF-08049820 in the fasted state
Pre-dose until 72 hours post dose
PK: Plasma Maximum Concentration (Cmax) of PF-08049820 in the fasted state
Pre-dose until 72 hours post dose
Secondary Endpoints
PK: Plasma Area Under the Concentration Versus Time Curve (AUC) of PF-08049820 in the fed state
Pre-dose until 72 hours post dose
PK: Plasma Maximum Concentration (Cmax) of PF-08049820 in the fed state
Pre-dose until 72 hours post dose
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
First dose, up to follow up visit (28-35 days post last dose)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Treatment AEXPERIMENTALParticipants will receive a single dose of PF-08049820 short Modified release (MR) release rate (MR1) tablets under fasted conditions.
Treatment BEXPERIMENTALParticipants will receive a single dose of PF-08049820 long MR release rate (MR2) tablets under fasted conditions.
Treatment CEXPERIMENTALParticipants will receive a single dose of PF-08049820 Immediate Release (IR) tablets under fasted conditions.
Treatment DEXPERIMENTALParticipants will receive a single dose of PF-08049820 MR2 tablets under fed conditions.
Treatment EEXPERIMENTALParticipants will receive a single dose of PF-08049820 IR tablets under fed conditions.
Interventions
NameTypeDescription
PF-08049820 MR1DRUGAdministered orally
PF-08049820 MR2DRUGAdministered orally
PF-08049820 IRDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female participants of non-childbearing potential ≥18 years of age * BMI of 16-32 kg/m2; and a total body weight \>45 kg (99 lbs) * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures....

Countries:United States
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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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