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AZD8965 low dose

Phase 2

Idiopathic Pulmonary Fibrosis (IPF) | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Jun 25, 2026

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

Clinical trial landscape

AZD8965 low dose · 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 Sites190

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 StatesArgentinaAustraliaBulgariaCanadaChileChinaDenmarkFranceGermanyGreeceHungaryIsraelItalyJapanMexicoPolandSouth AfricaSouth KoreaSpainTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)

LOWJun 25, 2026NCT07652658Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 25, 2026NCT07652658Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 25, 2026NCT07652658Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 18, 2026NCT07652658NEW_TRIAL: changed
LOWJun 18, 2026NCT07652658NEW_TRIAL: changed
LOWJun 18, 2026NCT07652658NEW_TRIAL: changed
LOWJun 18, 2026NCT07652658NEW_TRIAL: changed

Frequently asked questions about AZD8965 low dose

What is AZD8965 used for?

AZD8965 is an investigational small molecule being developed for idiopathic pulmonary fibrosis (IPF) and is also studied in healthy participants. It is currently in Phase 1 clinical development, with a Phase 2b trial recruiting participants with IPF.

Who makes AZD8965?

AZD8965 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN.

What phase is AZD8965 in?

AZD8965 is in Phase 1 clinical development. A Phase 1 study in healthy participants has been completed, and a Phase 2b trial in participants with idiopathic pulmonary fibrosis is currently recruiting.

What clinical trials is AZD8965 in?

AZD8965 has one completed Phase 1 trial (NCT06502379) in healthy participants, including Japanese and Chinese participants, and one recruiting Phase 2b trial (NCT07652658) in participants with IPF.

Is AZD8965 the same as AZD8965 low dose?

Yes, AZD8965 is also known as AZD8965 low dose. Both names refer to the same investigational drug being developed by AstraZeneca.

Is AZD8965 FDA approved?

AZD8965 is not FDA approved. It is an investigational drug currently in clinical development, with a completed Phase 1 study and an ongoing Phase 2b trial in idiopathic pulmonary fibrosis.