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PF-08049820

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |Pfizer, Inc.|Last Updated: Sep 4, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment181

FDA Designations

No designations recorded

Clinical trial landscape

PF-08049820 · 5 trials · 4 indications

Phase 2 1Phase 1 4
NCT07216027A Study to Learn About Study Medicine Called PF-08049820 in People With EczemaAtopic Dermatitis
RECRUITING165 Analytics
PHASE2RECRUITING
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent change from baseline in Eczema Area and Severity Index (EASI) total score at Week 12
Week 12
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B

Part A: Evaluate the relative bioavailability of different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.

Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B

Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.

Maximum observed plasma concentration (Cmax)
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B

Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.

Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of PF-08049820.
Day 1 through Day 38-45
PK: Area under the plasma concentration (AUC) of PF-08049820
Day 1 through Day 38-45
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
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Baseline up to Day 35 of last dosing period for Parts A and C and up to Day 45 for Part B

Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)

Number of Participants With Serious Adverse Events (SAEs)
Baseline up to Day 35 of last dosing period for Parts A and C and up to Day 45 for Part B

Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)

Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Baseline up to Day 21 of last dosing period for Parts A and C and up to Day 31 for Part B

Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)

Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Baseline up to Day 21 of last dosing period for Parts A and C and up to Day 31 for Part B

Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)

Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Baseline up to Day 21 of last dosing period for Parts A and C and up to Day 31 for Part B

Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)

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 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 1EXPERIMENTALStages 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
Sequence 1 (Part A)EXPERIMENTAL3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
Sequence 2 (Part A)EXPERIMENTAL3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
Sequence 3 (Part A)EXPERIMENTAL3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
Sequence 4 (Part A)EXPERIMENTAL3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
Sequence 5 (Part A)EXPERIMENTAL3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
Sequence 6 (Part A)EXPERIMENTAL3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
Sequence 7 (Optional Part B)EXPERIMENTAL3 different formulations of PF-08049820 administered orally with or without rabeprazole under fasted or fed conditions.
Treatment AEXPERIMENTALParticipants will receive single oral dose of PF-08049820.
Treatment BEXPERIMENTALParticipants will receive rabeprazole for 5 days followed by a single oral dose of PF-08049820 and rabeprazole.
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
Part A: Cohort 1EXPERIMENTALUp to 4 dosing periods in healthy adult participants. Each period consists of a single dose of PF-08049820 or placebo.
Part A: Cohort 2EXPERIMENTALUp to 4 dosing periods in healthy adult participants. Each period consists of a single dose of PF-08049820 or placebo.
Part A: Cohort 3EXPERIMENTALOne dosing period with a single dose of PF-08049820 or placebo in healthy adult Japanese participants.
Part B: Cohort 4EXPERIMENTALOne dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants.
Part B: Cohort 5EXPERIMENTALOne dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants.
Part B: Cohort 6EXPERIMENTALOne dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants.
Part B: Cohort 7EXPERIMENTALOne dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants.
Part C: Cohort 8EXPERIMENTALOne dosing period with a single dose of PF-08049820 or placebo in healthy adult participants.
Part C: Cohort 9EXPERIMENTALOne dosing period with a single dose of PF-08049820 or placebo in healthy adult participants.

Interventions

NameTypeDescription
PF-08049820DRUGTablet
PlaceboDRUGTablet
RabeprazoleDRUGAdministered orally
MidazolamDRUGAdministered orally
Dabigatran EtexilateDRUGAdministered orally
Portia (EE and LN) or equivalent oral tabletDRUGAdministered orally
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: Participants must meet the following criteria: 1. Are 18 to 64 years of age 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 baselin...

Countries:United StatesCanadaChinaJapan
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Recent Changes (Last 90 Days)

LOWSep 4, 2026NCT07216027lastUpdatePostDate: changed
LOWAug 17, 2026NCT07216027lastUpdatePostDate: changed
LOWAug 17, 2026NCT07216027lastUpdatePostDate: changed
LOWJul 28, 2026NCT07216027lastUpdatePostDate: changed
LOWJul 28, 2026NCT07216027lastUpdatePostDate: changed
LOWJun 16, 2026NCT07597928Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 16, 2026NCT07597928Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 16, 2026NCT07597928Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 16, 2026NCT07597928Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about PF-08049820

What is PF-08049820 used for?

PF-08049820 is an investigational small molecule being studied for use in healthy adults and in atopic dermatitis. It is currently in Phase 2 clinical development. The drug is being evaluated in clinical trials to learn how it is tolerated and how it acts in the body.

Who makes PF-08049820?

PF-08049820 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company is conducting clinical trials of this investigational small molecule in healthy adults and in atopic dermatitis.

What phase is PF-08049820 in?

PF-08049820 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in clinical trials for use in healthy adults and in atopic dermatitis.

What clinical trials is PF-08049820 in?

PF-08049820 is being studied in several clinical trials, including NCT06686797, NCT07190430, NCT07284173, and NCT07597928. These trials are evaluating the drug in healthy adults and in atopic dermatitis, with studies looking at tolerability, drug interactions, and different forms of the medicine.

Is PF-08049820 being studied in healthy volunteers?

Yes, PF-08049820 is being studied in healthy volunteers. Clinical trials include studies in healthy adults to learn how different amounts of the drug are tolerated and act in the body, how the body processes other medicines when taken with PF-08049820, and how different forms of the drug are absorbed and eliminated.