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Acetadote

Phase 1

Glioblastoma | Small molecule | Oncology |Cumberland Pharmaceuticals Inc.|Last Updated: Feb 6, 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 Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07387666Imaging Acetadote Metabolism in GlioblastomaEARLY_PHASE1 NOT YET_RECRUITING 10Jul 1, 2026Jul 1, 2028Feb 6, 20261 United States
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Study Endpoints
Primary Endpoints
To determine the effect of Acetadote on glioblastoma metabolism as measured by MRS.
Day 1 and up to 21 days from Day 1

The effect of Acetadote on glioblastoma metabolism will be assessed by measuring cysteine, glutathione, and lactate in glioblastoma through MRS.

Secondary Endpoints
To determine the effect of Acetadote on glioblastoma metabolism in resected tumor tissue as measured by LCMS
Day 1 and up to 21 days from Day 1
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Acetadote 150 mg/kg IVEXPERIMENTALAcetadote will be administered twice during this study: first before undergoing magnetic resonance spectroscopy (MRS) on Day 1 and second before undergoing surgical resection, which will take place between Days 2-21. Acetadote will be administered at a dose of 150 mg/kg IV over 60 minutes.
Interventions
NameTypeDescription
AcetadoteDRUGAcetadote 150 mg/kg in 500 cc 5% dextrose IV over 1 hour
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 1\. Glioblastoma * 2\. Newly diagnosed with no prior surgery, radiation, chemotherapy, or other tumor-treating agent * 3\. Age ≥18 years * 4\. KPS \> 70 * 5\. Adequate organ and marrow function as defined below: * \- Bilirubin ≤1.5 times upper limit of normal * \- AST and ALT ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07387666studyFirstPostDate: changed