Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Oral EP262
EP262 · 2 trials · 2 indications
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A TEAE is defined as an adverse event (AE) with an onset after the first dose of study drug or an existing event that worsened after the first dose during the study.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A TEAE is defined as an adverse event (AE) with an onset after the first dose of study drug or an existing event that worsened after the first dose during the study. AEs were graded for severity using the the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v.5). CTCAE grades were scored as: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant; Grade 4 = life threatening; Grade 5 = death related to the AE.
Clinical meaningfulness was determined by the investigator.
Clinical meaningfulness was determined by the investigator.
Clinical meaningfulness was determined by the investigator.
Assessed by the incidence of treatment-emergent adverse events
| Arm | Type | Description |
|---|---|---|
| EP262 150 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Oral EP262 | DRUG | Once daily |
| Placebo | DRUG | Once Daily |
Inclusion Criteria: * Clinically confirmed diagnosis of active atopic dermatitis for at least 1 year * BSA of 3% to 20% and a vIGA-AD score of ≥3 Exclusion Criteria: * Other active skin diseases associated with chronic pruritus * Clinically infected atopic dermatitis that requires antibiotic ther...
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EP262 is an investigational oral small molecule being developed for inflammatory skin conditions, specifically atopic dermatitis and chronic inducible urticaria. It is in Phase 2 clinical development and has not been approved by the FDA. Incyte Corporation is evaluating it as a potential treatment for these dermatologic indications.
EP262 targets MRGPRX2, a G protein-coupled receptor. By targeting this receptor, EP262 is designed to modulate mast cell activation, which is relevant to inflammatory skin conditions such as atopic dermatitis and chronic inducible urticaria.
EP262 is being developed by Incyte Corporation, which trades on the Nasdaq under the ticker INCY. Incyte is the sponsor of the clinical trials evaluating EP262 in atopic dermatitis and chronic inducible urticaria.
EP262 is in Phase 2 clinical development. A Phase 2a trial in atopic dermatitis has been completed, and a Phase 1b trial in chronic inducible urticaria has also been completed. EP262 is investigational and has not been approved by the FDA.
EP262 has been studied in two completed trials: NCT06144424, a Phase 2a randomized, double-blind, placebo-controlled study in atopic dermatitis, and NCT06050928, a Phase 1b open-label study in chronic inducible urticaria. Both trials enrolled adults and were conducted in multiple countries.
Yes, Oral EP262 is another name for EP262. Both refer to the same investigational small molecule developed by Incyte Corporation for atopic dermatitis and chronic inducible urticaria.