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-Ibrexafungerp

Phase 1

Fungal Infection | Small molecule | Infectious Disease |SCYNEXIS, Inc.|Last Updated: Aug 14, 2020

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04307082ADME Study of [14C]-Ibrexafungerp in Healthy Male SubjectsPHASE1 COMPLETED 6Dec 5, 2019Jun 30, 2020Aug 14, 20201 United Kingdom
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Study Endpoints
Primary Endpoints
Mass balance
Day 20

Amount recovered expressed as a percentage of the dose administered

Secondary Endpoints
Routes and rates of elimination of [14C]-ibrexafungerp
Day 20
Number of subjects with treatment-emergent adverse events
Day 20
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
IbrexafungerpEXPERIMENTALOral \[14C\]-Ibrexafungerp Single Dose
Interventions
NameTypeDescription
[14C]-IbrexafungerpDRUGRadio-labeled Ibrexafungerp, single dose.
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Eligibility Criteria
Age Range30 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Healthy males * Age 30 to 65 years of age at the time of signing informed consent * Must be willing and able to participate in the whole study * Must provide written informed consent * Must agree to adhere to the contraception requirements Key Exclusion Criteria: * Subje...

Countries:United Kingdom
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Competitive Landscape -Fungal Infections 10 trials