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CVL-865 High dose

Phase 1

Panic Disorder | Small molecule | Other |AbbVie Inc.|Last Updated: Jan 10, 2022

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
UNCONTROLLED
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04592536A Trial of the Effect of CVL-865 on Panic Symptoms Induced by Carbon Dioxide Inhalation in Healthy SubjectsPHASE1 COMPLETED 56Oct 1, 2020Dec 1, 2021Jan 10, 2022 -
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Study Design & Arms
Interventions
NameTypeDescription
CVL-865 High doseDRUGHigh dose CVL-865: Will be administered as 5mg BID for 2 days followed by 12.5mg BID for another 2 days during the Titration Phase. 25mg will be administered during the Maintenance Phase (3 days of BID and morning dose only on the 4th day)
Alprazolam 1mg XRDRUGAlprazolam 1mg XR will be administered for 8 days BID (morning dose only on 8th day)
PlaceboDRUGPlacebo, oral tablet/capsule will be administered for 8 days BID (morning dose only on 8th day)
CVL-865 low doseDRUGLow dose CVL-865, oral tablets. Will be administered as 2.5mg BID for 2 days followed by 5mg BID for another 2 days during the Titration Phase. 7.5mg BID will be administered during the Maintenance Phase (3 days of BID and morning dose only on 4th day)
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