Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-08049820 · 5 trials · 4 indications
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.
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.
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.
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
| Arm | Type | Description |
|---|---|---|
| Arm 2 | EXPERIMENTAL | Stages 1 and 2: Tablets taken by mouth daily for 12 weeks |
| Arm 3 | EXPERIMENTAL | Stages 1 and 2: Tablets taken by mouth daily for 12 weeks |
| Arm 1 | EXPERIMENTAL | Stages 1 and 2: Tablets taken by mouth daily for 12 weeks |
| Arm 4 | PLACEBO_COMPARATOR | Stages 1 and 2: Tablets taken by mouth daily for 12 weeks |
| Sequence 1 (Part A) | EXPERIMENTAL | 3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
| Sequence 2 (Part A) | EXPERIMENTAL | 3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
| Sequence 3 (Part A) | EXPERIMENTAL | 3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
| Sequence 4 (Part A) | EXPERIMENTAL | 3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
| Sequence 5 (Part A) | EXPERIMENTAL | 3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
| Sequence 6 (Part A) | EXPERIMENTAL | 3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
| Sequence 7 (Optional Part B) | EXPERIMENTAL | 3 different formulations of PF-08049820 administered orally with or without rabeprazole under fasted or fed conditions. |
| Treatment A | EXPERIMENTAL | Participants will receive single oral dose of PF-08049820. |
| Treatment B | EXPERIMENTAL | Participants will receive rabeprazole for 5 days followed by a single oral dose of PF-08049820 and rabeprazole. |
| Baseline Midazolam | OTHER | Participants will receive a single dose of 2 mg midazolam in the morning on Day 1 |
| Baseline dabigatran etexilate | OTHER | Participants will receive a single dose of 150 mg dabigatran etexilate in the morning on Day 1 |
| Baseline oral contraceptives | OTHER | Participants 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) midazolam | EXPERIMENTAL | Participants 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 etexilate | EXPERIMENTAL | Participants 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 contraceptives | EXPERIMENTAL | Participants 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 1 | EXPERIMENTAL | Up to 4 dosing periods in healthy adult participants. Each period consists of a single dose of PF-08049820 or placebo. |
| Part A: Cohort 2 | EXPERIMENTAL | Up to 4 dosing periods in healthy adult participants. Each period consists of a single dose of PF-08049820 or placebo. |
| Part A: Cohort 3 | EXPERIMENTAL | One dosing period with a single dose of PF-08049820 or placebo in healthy adult Japanese participants. |
| Part B: Cohort 4 | EXPERIMENTAL | One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants. |
| Part B: Cohort 5 | EXPERIMENTAL | One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants. |
| Part B: Cohort 6 | EXPERIMENTAL | One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants. |
| Part B: Cohort 7 | EXPERIMENTAL | One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants. |
| Part C: Cohort 8 | EXPERIMENTAL | One dosing period with a single dose of PF-08049820 or placebo in healthy adult participants. |
| Part C: Cohort 9 | EXPERIMENTAL | One dosing period with a single dose of PF-08049820 or placebo in healthy adult participants. |
| Name | Type | Description |
|---|---|---|
| PF-08049820 | DRUG | Tablet |
| Placebo | DRUG | Tablet |
| Rabeprazole | DRUG | Administered orally |
| Midazolam | DRUG | Administered orally |
| Dabigatran Etexilate | DRUG | Administered orally |
| Portia (EE and LN) or equivalent oral tablet | DRUG | Administered orally |
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...
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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.
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.
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.
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.
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.