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INCA033989

Phase 3

Essential Thrombocythemia | Small molecule | Other |Incyte Corporation|Last Updated: Jun 3, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment426
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07623200A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential ThrombocythemiaPHASE3 NOT YET_RECRUITING 426Jul 31, 2026Nov 1, 2030Jun 3, 2026 -
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Study Endpoints
Primary Endpoints
Durable clinicohematologic response (DCR)
Week 24

Normalization of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.

Secondary Endpoints
Reduction from baseline in calreticulin exon 9 frameshift mutation(s) (mutCLAR) variant allele frequency (VAF)
Week 24
Durable clinicohematologic response (DCR)
Week 48
Durable partial clinicohematologic response (DPR)
Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
INCA033989EXPERIMENTALAdministered intravenous (IV) in accordance with the protocol-defined requirements.
Best Available Therapy (BAT)EXPERIMENTALBest Available Therapy (BAT) will be selected by the investigator.
Interventions
NameTypeDescription
INCA033989DRUGAdministered intravenous (IV) in accordance with the protocol-defined requirements.
Best Available TreatmentDRUGBest Available Therapy (BAT) will be selected by the investigator.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Confirmed diagnosis of high-risk ET. * Presence of mutCALR. * Prior treatment with at least 1 cytoreductive therapy. Exclusion Criteria: * Presence of any hematologic malignancy other than ET. * Major bleeding or thrombosis within the last 3 months prior to study enrollment....

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Competitive Landscape -Essential Thrombocythemia 9 trials
Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07623200NEW_TRIAL: changed
LOWJun 4, 2026NCT07623200NEW_TRIAL: changed
LOWJun 4, 2026NCT07623200NEW_TRIAL: changed
LOWJun 4, 2026NCT07623200NEW_TRIAL: changed
LOWJun 4, 2026NCT07623200NEW_TRIAL: changed