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AV-101

Phase 2

Major Depressive Disorder | Small molecule | Psychiatry |Vistagen Therapeutics, Inc.|Last Updated: Oct 9, 2019

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment180
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03078322AV-101 as Adjunct Antidepressant Therapy in Patients With Major DepressionPHASE2 COMPLETED 180Mar 5, 2018Oct 1, 2019Oct 9, 201922 United States
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Study Endpoints
Primary Endpoints
Montgomery Åsberg Depression Rating Scale 10-item version (MADRS-10)
2 weeks

Depression questionnaire

Secondary Endpoints
Time course of improvement including response rates
2 weeks
Safety and tolerability will be assessed by incidence of adverse events (AEs)
2 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AV-101EXPERIMENTALL-4-chlorokynurenine 1440 mg daily for 14 days
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
AV-101DRUGOral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant)
PlaceboDRUGOral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant)
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Diagnosed with MDD, single or recurrent, and currently experiencing a MDE of at least 8 weeks in duration. * Has a history of inadequate response to at least 1 approved antidepressant including at least 1 and no more than 3 during the current depressive episode. * Meet the thr...

Countries:United States
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