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EP262

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |Incyte Corporation|Last Updated: Aug 24, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

EP262 · 3 trials · 3 indications

Phase 2 1Phase 1 2
NCT06144424Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Atopic DermatitisAtopic Dermatitis
COMPLETED32 Analytics
PHASE2COMPLETED
Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Atopic Dermatitis
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
up to Week 10

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.

Number of Participants With Any ≥Grade 3 TEAE
up to Week 10

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.

Number of Participants With Clinically Meaningful Changes From Baseline in Vital Signs
up to Week 10

Clinical meaningfulness was determined by the investigator.

Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECGs )
up to Week 10

Clinical meaningfulness was determined by the investigator.

Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Hematology, Chemistry, or Coagulation Parameters
up to Week 10

Clinical meaningfulness was determined by the investigator.

Mass balance of [14C]-EP262
Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)

Assessed by the total recovery of radioactivity from urine and feces

Pharmacokinetics (PK) of EP262 and [14C]
Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)

Assessed by the concentration of EP262 in plasma and \[14C\] in whole blood, plasma, urine, and feces

Safety and tolerability of EP262
Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)

Assessed by the incidence of treatment-emergent adverse events

Secondary Endpoints

Number of Participants With a Change From Baseline to Week 6 in Gene Expression Signature and Skin Histology (Epidermal Thickness, Immune Cell Infiltration, Markers of Epidermal Proliferation) as Assessed From Biopsies of Lesional Skin
Baseline; Week 6
Metabolite profile of EP262
Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
Safety and tolerability of [14C]-EP262
Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EP262 150 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
[14C]-EP262 25 mgEXPERIMENTALAdministered orally.

Interventions

NameTypeDescription
Oral EP262DRUGOnce daily
PlaceboDRUGOnce Daily
EP262DRUGSingle dose of \[14C\]-EP262 administered orally.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites10

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...

Countries:United StatesCanadaGermanyNetherlandsSpain
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Frequently asked questions about EP262

What is EP262 used for?

EP262 is an investigational small molecule being developed by Incyte Corporation for chronic inducible urticaria and atopic dermatitis. It has been studied in clinical trials involving healthy participants, as well as patients with these dermatologic conditions.

Who makes EP262?

EP262 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY.

What phase is EP262 in?

EP262 is in clinical development. It has completed Phase 1 and Phase 2 trials, including a Phase 2a study in atopic dermatitis. It is not FDA approved and remains investigational.

What clinical trials is EP262 in?

EP262 has been studied in three completed trials: NCT06050928 (Phase 1b in chronic inducible urticaria), NCT06144424 (Phase 2a in atopic dermatitis), and NCT06645704 (Phase 1 healthy volunteer study). All trials are completed.

Is EP262 the same as any other drug?

No alternative names for EP262 have been identified. It is referred to solely as EP262 in clinical trial records and by its developer, Incyte Corporation.