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FP-101

Phase 2

Hot Flashes | Small molecule | Other |IQVIA Holdings, Inc.|Last Updated: Nov 1, 2018

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 Enrollment109
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03285672FP-101 for the Treatment of Hot Flashes in Postmenopausal WomenPHASE2 COMPLETED 109 — — Mar 26, 2018Oct 29, 2018Nov 1, 201812 United States
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Study Endpoints
Primary Endpoints
The primary efficacy endpoint for the main study is the change in the frequency of moderate-to-severe hot flashes.
Baseline to Week 8
Secondary Endpoints
Change in the severity of moderate-to-severe hot flashes.
Baseline to Week 8
Change in the frequency of moderate-to-severe hot flashes.
Baseline to Week 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTALFP-101
Arm 2PLACEBO_COMPARATORPlacebo Comparator
Interventions
NameTypeDescription
FP-101DRUGDose 1
Placebo ComparatorDRUGDose 1
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Eligibility Criteria
Age Range40 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: Subjects may be enrolled in the main study only if they meet all of the following criteria: * Subject must be a female \>40 years of age at screening. * Subject must have reported more than 7 to 8 moderate-to-severe hot flashes per day or 50 to 60 hot flashes per week for at le...

Countries:United States
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