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Lexapro

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00648661Food Study of Escitalopram Oxalate Tablets 20 mg to Lexapro® Tablets 20 mgPHASE1 COMPLETED 35Sep 1, 2004Oct 1, 2004Apr 24, 20241 United States
NCT00648570Fasting Study of Escitalopram Oxalate Tablets 20 mg and Lexapro® Tablets 20 mgPHASE1 COMPLETED 37Aug 1, 2004Oct 1, 2004Apr 24, 20241 United States
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Study Endpoints
Primary Endpoints
Bioequivalence
within 30 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
1EXPERIMENTALEscitalopram Oxalate Tablets 20 mg
2ACTIVE_COMPARATORLexapro® Tablets 20 mg
Interventions
NameTypeDescription
Escitalopram Oxalate Tablets 20 mgDRUG20mg, single dose fed
Lexapro® Tablets 20 mgDRUG20mg, single dose fed
Lexapro® Tablets (20 mgDRUG20mg, single dose fasting
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum β-human chorionic gonadotropin (β-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening p...

Countries:United States
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