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ALXN2350

Phase 1

BAG3 Mutation Associated Dilated Cardiomyopathy | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Aug 28, 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

ALXN2350 · 1 trial · 1 indication

Phase 1 1
NCT07218887ALXN2350 in Adult Participants With BAG3-Associated Dilated CardiomyopathyBAG3 Mutation Associated Dilated Cardiomyopathy
RECRUITING6 Analytics
PHASE1RECRUITING
ALXN2350 in Adult Participants With BAG3-Associated Dilated Cardiomyopathy
BAG3 Mutation Associated Dilated CardiomyopathyUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Baseline up to Week 78

Secondary Endpoints

Part B: Number of Participants With TEAEs and SAEs
Baseline up to Week 78
Parts A and B: Number of Participants With Cardiac Events at Weeks 52 and 78
Weeks 52 and 78
Parts A and B: Time to the First Event of Death, Heart Transplant, Mechanical Circulating Support, or Aborted Sudden Cardiac Death
Baseline up to Week 78
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALXN2350EXPERIMENTALParticipants will receive one of three dose levels of ALXN2350 depending on the cohort.

Interventions

NameTypeDescription
ALXN2350DRUGALXN2350 is a gene therapy product consisting of an AAV9 capsid containing BAG3 transgene. It is administered as a single intravenous (IV) infusion.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Pathogenic or likely pathogenic mutation in BAG3 * Medical history of diagnosis of DCM * Stable combination of HF SoC medications * Adequate acoustic windows for echocardiography * LVEF \> 15% and ≤ 45% at Screening by echocardiography * Diagnosis of chronic HF for at least 3 ...

Countries:United StatesItalySpainUnited Kingdom
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Recent Changes (Last 90 Days)

LOWAug 28, 2026NCT07218887lastUpdatePostDate: changed
LOWAug 28, 2026NCT07218887lastUpdatePostDate: changed
LOWAug 20, 2026NCT07218887lastUpdatePostDate: changed
LOWAug 20, 2026NCT07218887lastUpdatePostDate: changed
LOWAug 20, 2026NCT07218887lastUpdatePostDate: changed
LOWAug 20, 2026NCT07218887lastUpdatePostDate: changed
LOWJun 16, 2026NCT07218887lastUpdatePostDate: changed
LOWJun 16, 2026NCT07218887lastUpdatePostDate: changed
LOWJun 16, 2026NCT07218887lastUpdatePostDate: changed
LOWJun 16, 2026NCT07218887lastUpdatePostDate: changed

Frequently asked questions about ALXN2350

What is ALXN2350 used for?

ALXN2350 is an investigational small molecule being developed for BAG3 mutation associated dilated cardiomyopathy, a cardiovascular condition. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes ALXN2350?

ALXN2350 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical trials.

What phase is ALXN2350 in?

ALXN2350 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for any use. A Phase 1 trial is currently recruiting participants to evaluate the drug in adults with BAG3 mutation associated dilated cardiomyopathy.

What clinical trials is ALXN2350 in?

ALXN2350 is being studied in a Phase 1 clinical trial with the identifier NCT07218887. This trial is titled 'ALXN2350 in Adult Participants With BAG3-Associated Dilated Cardiomyopathy' and is currently recruiting participants in the United States, Italy, Spain, and the United Kingdom.

Is ALXN2350 the same as any other drug?

ALXN2350 is the primary name for this investigational drug. No alternative names have been reported for this asset in the available information. It is being studied under the clinical trial identifier NCT07218887.