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NEO100

Phase 2

Residual, Progressive or Recurrent Grade II or III Meningioma | Small molecule | Other |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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05023018NEO100 and High-Grade MeningiomaPHASE2 RECRUITING 30Jul 1, 2022Jun 30, 2027Mar 2, 20263 United States
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Study Endpoints
Primary Endpoints
Progression free survival as six months (PFS6).
6 months

Progression free survival

Secondary Endpoints
Objective Tumor response to NEO100 as determined by RANO criteria
6 months
Overall survival
12 months
Perillic acid measurement
30 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Patients with high-grade meningiomaEXPERIMENTAL30 patients with residual high-grade meningioma following resection surgery, radiographically-confirmed progression of high-grade meningioma or recurrent high-grade meningioma
Interventions
NameTypeDescription
NEO100DRUGNEO100 is a purified form of perillyl alcohol.
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria Patient must: 1. Have histologically confirmed WHO Grade II or III meningioma that is residual, progressive or recurrent following at least minimally safe resection and radiation therapy. Metastatic meningiomas are allowed. 1. Residual disease is defined as residual measurab...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05023018primaryCompletionDate: changed
LOWMay 24, 2026NCT05023018studyFirstPostDate: changed