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FP-101

Phase 2

Vasomotor Symptoms | Small molecule | Other |Icon Plc|Last Updated: Oct 26, 2023

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 Enrollment105
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05312567FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor SymptomsPHASE2 COMPLETED 105 — — Mar 24, 2021Jul 31, 2023Oct 26, 202312 United States
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Study Endpoints
Primary Endpoints
Change in the frequency (average daily number) of moderate-to-severe hot flashes.
Recorded every 12 hrs over a 1-week treatment period.

Subjects use a digital platform to record hot flash frequency in a daily eDiary.

Secondary Endpoints
Change in the severity (average daily rating) of moderate-to-severe hot flashes.
Recorded every 12 hrs over a 1-week treatment period.
Change in nighttime awakenings (average daily number) with or without night sweats.
Recorded every morning over a 1-week treatment period.
Evaluate the clinical meaningfulness of VMS changes after 1-week of treatment.
After 1 week of treatment at the end-of-study visit.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Active Treatment (FP-101)EXPERIMENTALWhite to off-white extended-release, round tablets containing FP-101.
Matching placeboPLACEBO_COMPARATORWhite to off-white round tablets without the active ingredient but otherwise matching in size and appearance.
Interventions
NameTypeDescription
FP-101DRUGdaily oral tablet administration (b.i.d.)
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Eligibility Criteria
Age Range46 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Peri- and Post-Menopausal female subjects (\>45 yrs) experiencing a min of 7-8 moderate to severe hot flashes per day * Able/willing to provide informed consent. * Able/willing to complete all study procedures and visits. * Able/willing to not use any over-the-counter (OTC) co...

Countries:United States
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