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JZP3507

Phase 2

Meningioma | Small molecule | Other |Jazz Pharmaceuticals plc|Last Updated: Apr 16, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07533942A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 MeningiomaPHASE2 NOT YET_RECRUITING 30 — — Jun 1, 2026Oct 16, 2031Apr 16, 20265 United States
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Study Endpoints
Primary Endpoints
Overall Response Rate (ORR) as Assessed by Response Assessment in Neuro-Oncology (RANO) Criteria and Evaluated by Blinded Independent Central Review (BICR)
From first dose until death, withdrawal of consent, or lost to follow-up, up to 40 months.

ORR is the best response of confirmed complete response (CR), partial response (PR), or minor response (MR) during the study, as per RANO criteria

Secondary Endpoints
Duration of Response (DOR)
From first dose until death, withdrawal of consent, or lost to follow-up, up to 64 months.
Time to Response (TTR)
From first dose until death, withdrawal of consent, or lost to follow-up, up to 64 months.
Disease Control Rate (DCR)
From first dose until death, withdrawal of consent, or lost to follow-up, up to 64 months.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
JZP3507 (ONC206)EXPERIMENTAL -
Interventions
NameTypeDescription
JZP3507DRUGParticipants will receive oral JZP3507 monotherapy twice daily, on 3 consecutive days per week in 28-day cycles.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Key Inclusion Criteria: Age 1. Is ≥ 18 years of age at the time of signing the informed consent. Type of Participant and Disease Characteristics 2. Has histologically confirmed Grade 2 or 3 meningioma. 3. Has failed, is not a candidate for, or has declined standard of care treatment for mening...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07533942primaryCompletionDate: changed
LOWMay 24, 2026NCT07533942studyFirstPostDate: changed
LOWMay 21, 2026NCT07533942NEW_TRIAL: changed
LOWMay 21, 2026NCT07533942NEW_TRIAL: changed