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JZP3507

Phase 2

Meningioma | Small molecule | Oncology |Jazz Pharmaceuticals plc|Last Updated: Jul 30, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

JZP3507 · 1 trial · 1 indication

Phase 2 1
NCT07533942A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 MeningiomaMeningioma
RECRUITING30 Analytics
PHASE2RECRUITING
A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma
MeningiomaUnlock trial analytics

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 36 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 36 months.
Time to Response (TTR)
From first dose until death, withdrawal of consent, or lost to follow-up, up to 36 months.
Disease Control Rate (DCR)
From first dose until death, withdrawal of consent, or lost to follow-up, up to 36 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 to 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)

LOWJul 30, 2026NCT07533942Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 30, 2026NCT07533942Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about JZP3507

What is JZP3507 used for?

JZP3507 is an investigational small molecule being studied for the treatment of recurrent Grade 2 or 3 meningioma. It is currently in Phase 2 clinical development for this oncology indication.

Who makes JZP3507?

JZP3507 is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker JAZZ.

What phase is JZP3507 in?

JZP3507 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 trial is currently recruiting participants.

What clinical trials is JZP3507 in?

JZP3507 is being evaluated in a Phase 2 clinical trial with the identifier NCT07533942, titled 'A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma'. The trial is recruiting 30 adult participants in the United States.

Is JZP3507 the same as ONC206?

Yes, JZP3507 is also known as ONC206. The clinical trial NCT07533942 refers to the drug as JZP3507 (ONC206), indicating that both names refer to the same investigational compound.