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Perillyl alcohol

Phase 1

Glioblastoma Multiforme | Small molecule | Oncology |NeOnc Technologies Holdings, Inc.|Last Updated: Mar 2, 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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment49
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02704858Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated GliomaPHASE1 RECRUITING 49 — — Aug 1, 2017Jun 1, 2026Mar 2, 202612 United States
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Study Endpoints
Primary Endpoints
Phase 1 Primary Outcome: Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Up to 6 months
Phase 2 Primary Outcome: Number of Participants Who Are Alive Each Month For 6 Months
Up to 6 months
Phase 2 Primary Outcome: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related To Treatment
6 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NEO100 Phase 1EXPERIMENTALIntranasal delivery of NEO100 (perillyl alcohol) four times a day, escalation up to four different doses to determine maximum tolerated dose.
NEO100 Phase 2AEXPERIMENTALIntranasal delivery of NEO100 (perillyl alcohol) four times a day. Treatment of total of 25 patients at maximum tolerated dose.
Interventions
NameTypeDescription
Perillyl alcoholDRUGIntranasal administration
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria To be eligible to participate in the study, a patient must meet all of the following inclusion criteria: * Patient must have radiographically-confirmed progression of, or recurrent, primary or secondary Grade IV glioma, including infratentorial (brainstem, cerebellar) glioma (co...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT02704858primaryCompletionDate: changed
LOWMay 24, 2026NCT02704858studyFirstPostDate: changed