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ATR04-484

Phase 1

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

Target and mechanism

Molecular targetEGFR
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment32

FDA Designations

FAST_TRACK

Clinical trial landscape

ATR04-484 · 1 trial · 1 indication

Phase 1 1
NCT06830863A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal ToxicityEGFR Inhibitor-associated Rash
RECRUITING32 Analytics
PHASE1RECRUITING
A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity
EGFR Inhibitor-associated RashUnlock trial analytics

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 to 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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Frequently asked questions about ATR04-484

What is ATR04-484 used for?

ATR04-484 is an investigational small molecule being developed for the treatment of EGFR inhibitor-associated rash, a dermatologic condition that can occur in patients receiving EGFR inhibitor therapy. It is currently in Phase 1 clinical development.

What does ATR04-484 target?

ATR04-484 targets EGFR, the epidermal growth factor receptor. By targeting this protein, the drug is designed to address EGFR inhibitor-associated rash, a dermatologic toxicity linked to EGFR pathway activity.

Who makes ATR04-484?

ATR04-484 is being developed by Azitra Inc, a biopharmaceutical company. Azitra's stock is traded under the ticker symbol AZTR on the stock market.

What phase is ATR04-484 in?

ATR04-484 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug has received Fast Track designation from the FDA.

What clinical trials is ATR04-484 in?

ATR04-484 is being evaluated in a Phase 1 clinical trial with the identifier NCT06830863. This randomized, double-blind, placebo-controlled study is recruiting 32 participants in the United States to evaluate the drug for EGFR inhibitor-associated rash.

Is ATR04-484 the same as another drug?

No, ATR04-484 is a distinct investigational drug. It is not known to be the same as any other approved or investigational medication. It is being studied specifically for its potential to treat EGFR inhibitor-associated rash.