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Povorcitinib

Phase 3

Hidradenitis Suppurativa (HS) | Small molecule | Dermatology |Incyte Corporation|Last Updated: Jun 1, 2026

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
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials5
Total Enrollment2,484
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06855498Rollover Study for Participants Previously Enrolled in Clinical Trials of PovorcitinibPHASE3 RECRUITING 600Feb 28, 2025Feb 28, 2028Jun 1, 2026317 United States, Argentina +18
NCT06212999A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis SuppurativaPHASE3 ACTIVE NOT_RECRUITING 617Jan 30, 2024Dec 26, 2026Mar 23, 2026165 United States, Australia +15
NCT05620836A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)PHASE3 COMPLETED 619Feb 22, 2023Nov 21, 2025Jan 9, 2026101 United States, Australia +9
NCT05620823A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis SuppurativaPHASE3 COMPLETED 608Dec 19, 2022Dec 23, 2025Feb 10, 2026104 United States, Austria +10
NCT07213973Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis SuppurativaPHASE2 RECRUITING 40Feb 2, 2026Mar 25, 2028May 27, 202629 United States, Canada
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Study Endpoints
Primary Endpoints
Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)
Up to approximately 3 years

Adverse events either reported for the first time in this Protocol or any AE ongoing and defined as treatment-emergent from the parent Protocol.

Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)
Week 12

HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.

Apparent clearance
Up to Week 24
Apparent volume of distribution
Up to Week 24
Apparent oral absorption rate constant
Up to Week 24
Absorption lag time
Up to Week 24
Maximum plasma drug concentration at steady state
Up to Week 24
Average plasma drug concentration at steady state
Up to Week 24
Plasma concentration at steady state for the dosing interval
Up to Week 24
Time to maximum plasma concentration at steady state
Up to Week 24
Terminal half-life
Up to Week 24
Secondary Endpoints
Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit
Up to approximately 3 years
Proportion of participants with Serious Treatment-Emergent Adverse Events (TEAEs)
up to approximately 56 weeks
Proportion of participants with TEAEs leading to study drug discontinuation
up to approximately 56 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
povorcitinibEXPERIMENTALParticipants will receive povorcitinib treatment with the same schedule and dose options as the study in which they originally enrolled.
Cohort AEXPERIMENTALPovorcitinib at the protocol-defined dose strength based on cohort assignment.
Cohort BEXPERIMENTALPovorcitinib at the protocol-defined dose strength based on cohort assignment.
Cohort CEXPERIMENTALPovorcitinib at the protocol-defined dose strength based on cohort assignment.
Povorcitinib Dose AEXPERIMENTALParticipants will receive Povorcitinib Dose A for 54 weeks.
Povorcitinib Dose BEXPERIMENTALParticipants will receive Povorcitinib Dose B for 54 weeks.
PlaceboPLACEBO_COMPARATORParticipants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.
Interventions
NameTypeDescription
povorcitinibDRUGStudy drug will be taken orally as defined by the protocol.
PlaceboDRUGOral, Tablet
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites317

Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study. * Completed the treatment period of a predetermined, Incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment. * Received clinical benefit from ...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBulgariaCanadaChileCzechiaFranceGermanyGreeceHungaryItalyNetherlandsPolandSouth KoreaSpainSwitzerlandUnited KingdomDenmarkJapan
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT06855498lastUpdatePostDate: changed
LOWJun 2, 2026NCT06855498lastUpdatePostDate: changed
LOWJun 2, 2026NCT06855498lastUpdatePostDate: changed
LOWMay 28, 2026NCT07213973lastUpdatePostDate: changed
LOWMay 28, 2026NCT07213973lastUpdatePostDate: changed
LOWMay 27, 2026NCT06855498lastUpdatePostDate: changed
LOWMay 27, 2026NCT06855498lastUpdatePostDate: changed
LOWMay 26, 2026NCT07213973primaryCompletionDate: changed
LOWMay 26, 2026NCT06855498primaryCompletionDate: changed
LOWMay 26, 2026NCT06212999primaryCompletionDate: changed
LOWMay 24, 2026NCT07213973studyFirstPostDate: changed
LOWMay 24, 2026NCT06855498studyFirstPostDate: changed
LOWMay 24, 2026NCT06212999studyFirstPostDate: changed