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Gocovri

Phase 2

Radiation Encephalopathy | Small molecule | Other |Supernus Pharmaceuticals, Inc.|Last Updated: Aug 15, 2025

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 Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07125222Use of Gocovri to Improve Disability Due to Radiation EncephalopathyPHASE2 NOT YET_RECRUITING 24Sep 1, 2025Aug 1, 2028Aug 15, 20251 United States
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Study Endpoints
Primary Endpoints
Change in the level of disability as measured by the Disability Rating Scale(DRS)
Baseline - 24 weeks.

The Disability Rating Scale (DRS) is a tool used to evaluate impairment, disability and handicap caused by brain injury. Scores range from 0 (No disability) to a maximum of 29 (indicating an extreme vegetative state).

Secondary Endpoints
Change in cognition based on the MoCA test.
Baseline - 24 weeks.
Change in 18F-FPEB avidity on PET/CT.
Baseline - 24 weeks.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Gocovri (extended-release amantidine)EXPERIMENTAL -
Interventions
NameTypeDescription
Gocovri (extended-release amantidine)DRUGGocovri is extended release formulation of amantidine. Starting on Day 1, patients will start Gocovri 137mg daily. If there is no dose-limited event after 28 days, the dose will be increased to 274mg daily which will become the new standard dose for the remaining 20 weeks of the patient's participation in the study.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Individuals ≥ 18 years of age. * Individuals with caregivers who are able to complete survey assessments for this study. * Prior brain radiation treatment. * Evidence of moderate-severe confluent white matter hyperintensity on MRI brain scan as judged by neuroradiology impress...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07125222studyFirstPostDate: changed