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ATR12-351

Phase 1

Netherton Syndrome | Small molecule | Rare Disease |Azitra Inc|Last Updated: Jul 29, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

ATR12-351 · 1 trial · 1 indication

Phase 1 1
NCT06137157Evaluation of Topical ATR12-351 in Adults With Netherton SyndromeNetherton Syndrome
COMPLETED6 Analytics
PHASE1COMPLETED
Evaluation of Topical ATR12-351 in Adults With Netherton Syndrome
Netherton SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events
84 days

Incidence, severity, seriousness and relatedness of all treatment-emergent adverse events

Secondary Endpoints

Investigator's Global Assessment (IGA)
42 days
Patient's Global Assessment (PGA)
42 days
NS-modified SCORAD
42 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Internal controlled armEXPERIMENTALATR12-351 on left side of body, vehicle on right side of body in one group; vehicle on left side of body, ATR12-351 on right side of body.

Interventions

NameTypeDescription
ATR12-351DRUGTopical ointment containing ATR12-351, a LEKTI-secreting strain of S. epidermidis
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Adults ≥18 years of age * Confirmed mutation of the serine protease inhibitor of Kazal type 5 (SPINK5) gene * Involvement of ≥20% of body surface area with skin changes consistent with Netherton syndrome Exclusion Criteria: * Use of biologic therapies, antibiotics, antihista...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMAug 29, 2026NCT06137157TRIAL_REMOVED: changed
MEDIUMAug 29, 2026NCT06137157TRIAL_REMOVED: changed
MEDIUMAug 29, 2026NCT06137157TRIAL_REMOVED: changed
HIGHJul 29, 2026NCT06137157Status: RECRUITING → COMPLETED
HIGHJul 29, 2026NCT06137157Status: RECRUITING → COMPLETED

Frequently asked questions about ATR12-351

What is ATR12-351 used for?

ATR12-351 is an investigational small molecule being developed for the treatment of Netherton Syndrome, a rare genetic skin disorder. It is administered topically and is currently in clinical development, having completed a Phase 1 trial in adults with the condition.

Who makes ATR12-351?

ATR12-351 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 ATR12-351 in?

ATR12-351 is in Phase 1 of clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial evaluating the drug has been completed.

What clinical trials is ATR12-351 in?

ATR12-351 has been studied in a completed Phase 1 clinical trial with the identifier NCT06137157, titled 'Evaluation of Topical ATR12-351 in Adults With Netherton Syndrome'. The trial enrolled 6 participants in the United States.

Is ATR12-351 FDA approved?

ATR12-351 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial, but it remains in clinical development and has not received approval for commercial use.