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CS-001

Phase 3

Canities | Small molecule | Other |Applied Therapeutics, Inc.|Last Updated: Dec 24, 2024

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_CONTROLLED
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06745336Clinical Study of CS-001 As a Treatment for Canities (Grey Hair)PHASE3 NOT YET_RECRUITING 240Jun 15, 2025Sep 15, 2027Dec 24, 2024 -
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Study Endpoints
Primary Endpoints
Greying Severity Score
Week [0,52]

Greying Severity Score (GSS). Mild Greying score between 0-5, Moderate Greying score between 6-10 and Severe Greying score between 11-15

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CS-001EXPERIMENTALCS-001 Topical Treatment
PlaceboPLACEBO_COMPARATORPlacebo Topical Treatment
Interventions
NameTypeDescription
CS-001DRUGCS-001 Topical Treatment
Placebo Topical SolutionDRUGPlacebo Topical Solution
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Eligibility Criteria
Age Range30 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Age 30 to 65 * Diagnosed with Grey Hair (Canities) * Willing and able to apply the treatment as directed, comply with study * Otherwise healthy * Able to give informed consent Exclusion Criteria: * A medical history that may interfere with study objectives * Women who are pr...

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