Recent Updates
Recently added Catalysts

Loxapine

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
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment53
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00648778Fasting Study of Loxapine Succinate Capsules 25 mg and Loxitane® Capsules 25 mgPHASE1 COMPLETED 53Jan 1, 2003Feb 1, 2003Apr 24, 20241 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Bioequivalence
within 30 days
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
1EXPERIMENTALLoxapine Succinate Capsules 25 mg
2ACTIVE_COMPARATORLoxitane® Capsules 25 mg
Interventions
NameTypeDescription
Loxapine Succinate Capsules 25 mgDRUG25mg, single dose fasting
Loxitane® Capsules 25 mgDRUG25mg, single dose fasting
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female a. Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. A...

Countries:United States
Unlock Eligibility Criteria