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XPF-005

Phase 1

Acne Vulgaris | Small molecule | Dermatology |Xenon Pharmaceuticals Inc.|Last Updated: Jan 22, 2019

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 Enrollment213
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02656043A Safety, Tolerability, Efficacy and Exposure Study of XEN801 Topical GelPHASE1 COMPLETED 213Sep 17, 2015Mar 17, 2017Jan 22, 201920 Canada
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Study Endpoints
Primary Endpoints
Change from Baseline in acne lesion count
Week 12
Secondary Endpoints
Change from Baseline in acne lesion count
Week 4 and 8
Change from Baseline in Investigator Global Assessment (IGA)
Week 4, 8 and 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
XPF-005ACTIVE_COMPARATORActive treatment: XPF-005 Gel
Vehicle gelPLACEBO_COMPARATORPlacebo: XPF-005 Vehicle Gel
Interventions
NameTypeDescription
XPF-005DRUGComparison of active treatment XPF-005 topical gel against Placebo (XPF-005 Vehicle Gel) applied to face for acne vulgaris.
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites20

Key Inclusion Criteria: 1. Aged between 18 and 50, inclusive 2. Male or female, agree to comply with contraceptive requirements 3. Signed Informed Consent Form 4. Clinical diagnosis of facial acne vulgaris defined as: * 25 to 75 inflammatory lesions, * 20 to 120 non-inflammatory lesions, and...

Countries:Canada
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