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AZD8965

Phase 2

Idiopathic Pulmonary Fibrosis (IPF) | Small molecule | Respiratory |AstraZeneca PLC|Trials Updated: Sep 21, 2026

AZD8965 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jul 2024

AZD8965 target and mechanism

ModalitySmall molecule

Also known as AZD8965 low dose

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment359

FDA Designations

No designations recorded

AZD8965 clinical trials

AZD8965 · 1 trial · 1 indication

Phase 2 1
NCT07652658A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.Idiopathic Pulmonary Fibrosis (IPF)
RECRUITING359 Analytics
PHASE2RECRUITING
A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
Idiopathic Pulmonary Fibrosis (IPF)Unlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the clinical efficacy of AZD8965 compared with placebo on the absolute change from baseline in FVC in mL at Week 24
at Week 24

Secondary Endpoints

Relationship between dose and clinical efficacy of AZD8965 at Week 24
Week 24
Change from baseline in FVC at Week 24
Week 24
Change in rate of decline in FVC at Week 24
Week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Placebo for AZD8965PLACEBO_COMPARATORPlacebo for AZD8965
AZD8965 low doseEXPERIMENTALAZD8965 low dose
AZD8965 medium doseEXPERIMENTALAZD8965 medium dose
AZD8965 high doseEXPERIMENTALAZD8965 high dose

Interventions

NameTypeDescription
Placebo for AZD8965OTHERPlacebo for AZD8965
AZD8965 low doseDRUGAZD8965 low dose
AZD8965 medium doseDRUGAZD8965 medium dose
AZD8965 high doseDRUGAZD8965 high dose
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites195

Inclusion Criteria: 1. Age ≥ 40 years 2. IPF diagnosis 3. Participants with IPF receiving locally approved antifibrotic therapies at a stable dose, or participants with IPF not receiving local standard of care 4. FVC ≥ 45% predicted of normal 5. DLCO corrected for hemoglobin ≥ 25% predicted of norm...

Countries:United StatesArgentinaAustraliaBulgariaCanadaChileChinaDenmarkFranceGermanyGreeceHungaryIsraelItalyJapanMexicoNetherlandsPolandSouth AfricaSouth KoreaSpainTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)

LOWSep 21, 2026NCT07652658lastUpdatePostDate: changed
LOWSep 21, 2026NCT07652658lastUpdatePostDate: changed

Frequently asked questions about AZD8965

What is AZD8965?

AZD8965 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN) for idiopathic pulmonary fibrosis, or IPF. It is currently in Phase 2 clinical development and has not been approved by the FDA. The program is being studied in a randomized, double-blind, placebo-controlled trial.

What is AZD8965 used for in idiopathic pulmonary fibrosis?

AZD8965 is being evaluated as a treatment for idiopathic pulmonary fibrosis (IPF), a chronic respiratory condition. It is an investigational therapy in Phase 2 development and is not approved for any indication. The ongoing study enrolls adults aged 40 years and older with IPF across multiple countries.

Who makes AZD8965?

AZD8965 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is running the Phase 2b clinical program for the drug in idiopathic pulmonary fibrosis. The asset is an investigational small molecule and remains in clinical development.

What phase is AZD8965 in?

AZD8965 is in Phase 2 development. The ongoing trial is a Phase 2b study in participants with idiopathic pulmonary fibrosis. AZD8965 is investigational and has not received FDA approval. No completed trials of AZD8965 have been reported.

What clinical trials is AZD8965 in?

AZD8965 is being studied in one active clinical trial, NCT07652658, titled A Phase IIb Study to Evaluate AZD8965 in Participants With IPF. The trial is currently recruiting and plans to enroll 359 participants. It is randomized, double-blind, and placebo-controlled, and is conducted across the United States, Europe, Asia, and other regions.

Is AZD8965 the same as AZD8965 low dose?

AZD8965 low dose is an alternative name used for AZD8965, the investigational small molecule developed by AstraZeneca PLC for idiopathic pulmonary fibrosis. Both names refer to the same Phase 2 asset. The ongoing Phase 2b trial, NCT07652658, is evaluating AZD8965 in participants with IPF.