Last reviewed 2026-05-24 · How we verify

ATR12-351

Azitra Inc. · Phase 1 active Small molecule ✓ Verified May 2026 Quality 10/100

ATR12-351 is a Small molecule drug developed by Azitra Inc.. It is currently in Phase 1 development. Also known as: ATR-12.

ATR12-351 is a small molecule being evaluated in a clinical study for the treatment of Netherton Syndrome. This study, NCT06137157, is a randomized, double-blind, vehicle-controlled, first-in-human safety, tolerability, and proof-of-concept study of topical ATR12-351 in adults with Netherton Syndrome.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	ATR12-351
Also known as	ATR-12
Sponsor	Azitra Inc.
Modality	Small molecule
Phase	Phase 1

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Evaluation of Topical ATR12-351 in Adults With Netherton Syndrome (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

ATR12-351 CI brief — competitive landscape report
ATR12-351 updates RSS · CI watch RSS
Azitra Inc. portfolio CI

Frequently asked questions about ATR12-351

What is ATR12-351?

ATR12-351 is a Small molecule drug developed by Azitra Inc..

Who makes ATR12-351?

ATR12-351 is developed by Azitra Inc. (see full Azitra Inc. pipeline at /company/azitra-inc).

Is ATR12-351 also known as anything else?

ATR12-351 is also known as ATR-12.

What development phase is ATR12-351 in?

ATR12-351 is in Phase 1.

Manufacturer: Azitra Inc. — full pipeline
Also known as: ATR-12

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing