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FMX114

Phase 1

Atopic Dermatitis | Small molecule | Immunology |VYNE Therapeutics Inc.|Last Updated: Aug 31, 2022

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04927572Safety, Pharmacokinetics and Efficacy of FMX114 Versus Vehicle in Adults With Atopic DermatitisPHASE1 COMPLETED 21Oct 13, 2021Aug 9, 2022Aug 31, 20227 United States, Australia
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Study Endpoints
Primary Endpoints
Mean Change from Baseline in Atopic Dermatitis Severity Index (ADSI) score at Day 29
Day 29
Incidence, type and severity of adverse events (AEs) at Day 43
Day 43
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FMX114EXPERIMENTAL -
VehiclePLACEBO_COMPARATOR -
Interventions
NameTypeDescription
FMX114DRUGActive Comparator
VehicleOTHERPlacebo Comparator
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Subjects must have the ability to understand and be willing to sign an informed consent form. 2. Aged ≥ 18 years, at time of screening visit. 3. Weight ≥ 40 kg, at time of screening visit. 4. Diagnosis of Atopic Dermatitix with a total body surface area (BSA) of AD involvemen...

Countries:United StatesAustralia
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