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KB304

Phase 1

Wrinkles in Decolletage | Monoclonal antibody | Other |Krystal Biotech, Inc.|Last Updated: May 13, 2025

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 Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06724900A Study Assessing KB304 for the Treatment of Wrinkles in WomenPHASE1 ACTIVE NOT_RECRUITING 19Nov 20, 2024Aug 1, 2025May 13, 20251 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability of KB304 versus placebo administered by intradermal injection
Up to 4 months

Treatment related adverse events as assessed by CTCAE

Secondary Endpoints
To evaluate the effect of KB304 versus placebo on dynamic wrinkles of the décolleté area.
Up to 4 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
KB304EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
KB304BIOLOGICALGenetically modified herpes simplex type 1 virus
0.9% Normal Saline (NS)DRUGPlacebo
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Eligibility Criteria
Age Range18 Years — 75 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Female in good general health, as determined by the Investigator, aged ≥18 and ≤75 at the time of consent. * Presence of moderate to severe dynamic wrinkles in the décolleté Target Area, as determined by the Investigator on the JDWS. * A Fitzpatrick skin phototype score of I-I...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06724900primaryCompletionDate: changed
LOWMay 24, 2026NCT06724900studyFirstPostDate: changed