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ONC206

Phase 2

Advanced Pheochromocytoma and Paraganglioma | Small molecule | Oncology |Jazz Pharmaceuticals plc|Last Updated: Feb 27, 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
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07282587Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and ParagangliomaPHASE2 RECRUITING 90Jan 2, 2026Dec 15, 2028Feb 27, 20269 United States
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Study Endpoints
Primary Endpoints
Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Up to 36 months.

ORR defined as the number of participants with a confirmed complete response (CR) or partial response during the study, as per RECIST v1.1.

Secondary Endpoints
Duration of Response (DOR)
Up to 36 months.
Time to Response (TTR)
Up to 36 months.
Disease Control Rate (DCR)
Up to 36 months.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Stage 1 ParticipantsEXPERIMENTAL150 mg ONC206 BID TIW
Stage 2: Dose 1EXPERIMENTALParticipants receiving ONC206 at dose (To be Determined \[TBD\] post stage 1).
Stage 2: Dose 2EXPERIMENTALParticipants receiving ONC206 at dose (TBD post stage 1).
Interventions
NameTypeDescription
ONC206DRUG150 mg BID TIW
ONC206: Dose 1DRUG -
ONC206: Dose 2DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion criteria: 1. Has histologically confirmed pheochromocytoma or paraganglioma that is unresectable as determined by the Investigator. 2. Has failed, is not a candidate for, or has declined standard of care treatment for PCPG. There is no limit on the number of prior systemic therapies. 3. M...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07282587primaryCompletionDate: changed
LOWMay 24, 2026NCT07282587studyFirstPostDate: changed