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ATR04-484

Phase 1

EGFR Inhibitor-associated Rash | Small molecule | Other |Azitra Inc|Last Updated: Feb 11, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06830863A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal ToxicityPHASE1 RECRUITING 32Aug 25, 2025Feb 15, 2027Feb 11, 20266 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability
57 days

Treatment-emergent adverse events

Secondary Endpoints
Severity of dermal toxicity
57 days
Pruritus
57 days
Quality-of-life assessment
57 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ATR04-484EXPERIMENTALTopically applied ATR04-484
VehiclePLACEBO_COMPARATORTopically applied vehicle
Interventions
NameTypeDescription
ATR04-484DRUGATR04-484 is a recombinant live biotherapeutic product (rLBP) containing the engineered S. epidermidis strain SE484 in an ointment formulation for topical use
VehicleDRUGTopically applied vehicle.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Adults ≥18 years of age * Has Grade 2 or 3 non-infected moderate to severe EGFRi-related dermal toxicity affecting the face (the neck, chest, back and other areas may also be affected) Exclusion Criteria: * Significant skin disease other than EGFRi-related dermal toxicity * ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06830863primaryCompletionDate: changed
LOWMay 24, 2026NCT06830863studyFirstPostDate: changed