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Purinethol

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 Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00648336Fasting Study of Mercaptopurine 50 mg and Purinethol® Tablets 50 mgPHASE1 COMPLETED 60Nov 1, 2003Dec 1, 2003Apr 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
1EXPERIMENTALMercaptopurine 50 mg
2ACTIVE_COMPARATORPurinethol® Tablets 50 mg
Interventions
NameTypeDescription
Mercaptopurine 50 mgDRUG50mg, single dose fasting
Purinethol® Tablets 50 mgDRUG50mg, single dose fasting
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male 3. Volunteers are to be sterile (documentation required) or during the course of the study, from study screen until 3 months after study exit, non-sterile male volunteers must use a spermicide-containing barrier method of contraception to...

Countries:United States
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