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AZD0292

Phase 2

Bronchiectasis With Pseudomonas Aeruginosa Colonization | Monoclonal antibody | Respiratory |AstraZeneca PLC|Last Updated: Aug 20, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment519

FDA Designations

No designations recorded

Clinical trial landscape

AZD0292 · 4 trials · 3 indications

Phase 2 2Phase 1 2
NCT07774403A Study of AZD0292 in Chinese Participants With Bronchiectasis and Chronic Pseudomonas Aeruginosa ColonizationBronchiectasis With Pseudomonas Aeruginosa Colonization
RECRUITING84 Analytics
NCT07088926A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa ColonizationBronchiectasis With Pseudomonas Aeruginosa Colonization
RECRUITING435 Analytics
PHASE2RECRUITING
A Study of AZD0292 in Chinese Participants With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
Bronchiectasis With Pseudomonas Aeruginosa ColonizationUnlock trial analytics
PHASE2RECRUITING
A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
Bronchiectasis With Pseudomonas Aeruginosa ColonizationUnlock trial analytics

Study Endpoints

Primary Endpoints

Annualized rate of exacerbations over a variable follow-up time
Min 28 weeks, max 52 weeks

To evaluate the effect of IV AZD0292 compared to placebo on the rate of moderate-to severe pulmonary exacerbations in participants with NCFBE and chronic colonization with PsA

Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse event of special interest (AESI)
Up to Extended Follow-up Period (Day 161)

To assess the safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy Japanese adult participants.

Number of Participants with Adverse Events
Up to 13 weeks

The safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy adult participants will be assessed.

Number of Participants with Adverse Events of Special Interest (AESI)
Up to 13 weeks

The safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy adult participants will be assessed.

Secondary Endpoints

Annualized rate of severe exacerbations over a variable follow-up time
Min 28 weeks, max 52 weeks
Change from baseline in QoL-B-RSS
Over the observation period (Week 0 to Last Dose+4 weeks)
Change from baseline in SGRQ score
Over the observation period (Week 0 to Last Dose+4 weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
AZD0292EXPERIMENTALAZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.
PlaceboPLACEBO_COMPARATORPlacebo administered starting on Day 1, subsequent administrations per schedule of assessments.
High-doseEXPERIMENTALHigh-Dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.
Low-doseEXPERIMENTALLow-dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.
AZD0292 Dose Level 1EXPERIMENTALParticipants will receive AZD0292 (dose level 1) or matching placebo on Day 1.
AZD0292 Dose Level 2EXPERIMENTALParticipants will receive AZD0292 (dose level 2) or matching placebo on Day 1.
AZD0292 Dose 1EXPERIMENTALParticipants will receive single dose of AZD0292 dose 1 as IV infusion on Day 1.
AZD0292 Dose 2EXPERIMENTALParticipants will receive single dose of AZD0292 dose 2 as IV infusion on Day 1.
AZD0292 Dose 3EXPERIMENTALParticipants will receive single dose of AZD0292 dose 3 as IV infusion on Day 1.

Interventions

NameTypeDescription
AZD0292DRUGAZD0292 administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.
PlaceboOTHERPlacebo administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * Participant must be ≥ 18 years of age at the time of signing the informed consent/assent. * Weight ≥ 35 kg. * Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 years i...

Countries:ChinaUnited StatesArgentinaAustraliaBelgiumBrazilCanadaChileDenmarkFranceGermanyGreeceIsraelItalyJapanMalaysiaNetherlandsPeruPhilippinesSouth KoreaSpainTaiwanThailandTurkey (Türkiye)United KingdomVietnam
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Recent Changes (Last 90 Days)

LOWAug 20, 2026NCT07774403NEW_TRIAL: changed
HIGHAug 20, 2026NCT07222254Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWAug 20, 2026NCT07774403NEW_TRIAL: changed
HIGHAug 20, 2026NCT07222254Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWAug 20, 2026NCT07774403NEW_TRIAL: changed
LOWAug 20, 2026NCT07774403NEW_TRIAL: changed
LOWAug 19, 2026NCT07088926lastUpdatePostDate: changed
LOWAug 19, 2026NCT07088926lastUpdatePostDate: changed
LOWAug 19, 2026NCT07088926lastUpdatePostDate: changed
LOWJul 31, 2026NCT07088926lastUpdatePostDate: changed
LOWJul 31, 2026NCT07088926lastUpdatePostDate: changed
LOWJul 2, 2026NCT07088926lastUpdatePostDate: changed
LOWJul 2, 2026NCT07088926lastUpdatePostDate: changed
LOWJun 23, 2026NCT07222254lastUpdatePostDate: changed
LOWJun 23, 2026NCT07222254lastUpdatePostDate: changed

Frequently asked questions about AZD0292

What is AZD0292 used for?

AZD0292 is an investigational monoclonal antibody being developed for bronchiectasis with chronic Pseudomonas aeruginosa colonization. It is also studied in healthy participants for safety and pharmacokinetic assessments. The drug is administered intravenously and is currently in Phase 2 clinical development for the bronchiectasis indication.

Who makes AZD0292?

AZD0292 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the safety, efficacy, and pharmacokinetics of AZD0292 in patients with bronchiectasis and chronic Pseudomonas aeruginosa colonization.

What phase is AZD0292 in?

AZD0292 is in Phase 2 clinical development for bronchiectasis with chronic Pseudomonas aeruginosa colonization. The drug is investigational and not yet approved by regulatory authorities. AstraZeneca is currently recruiting participants for Phase 2 trials evaluating its efficacy and safety in this patient population.

What clinical trials is AZD0292 in?

AZD0292 is being studied in several clinical trials. NCT07088926 is a Phase 2 study in participants aged 12 years and older with bronchiectasis and chronic Pseudomonas aeruginosa colonization. NCT07774403 is a Phase 2 study in Chinese participants with the same condition. NCT06311760 and NCT07222254 are completed Phase 1 studies in healthy participants.

Is AZD0292 FDA approved?

AZD0292 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for bronchiectasis with chronic Pseudomonas aeruginosa colonization. The drug is still in clinical development and has not yet received regulatory approval for any indication.