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AZD5462

Phase 2

Chronic Heart Failure | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Feb 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment375
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06299826A Phase IIb Study of AZD5462 in Patients With Chronic Heart FailurePHASE2 COMPLETED 375 — — Jun 4, 2024Feb 10, 2026Feb 18, 202656 United States, Bulgaria +8
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Study Endpoints
Primary Endpoints
Cohort A and B: Change from Baseline in Echocardiography Parameters
From Baseline to Week 25

To evaluate the effect of AZD5462 after treatment in participants with HF.

Secondary Endpoints
Cohort A and B: Change from Baseline in Echocardiography Parameters
From Baseline to Week 13 and Week 25
Cohorts A and B: Change from Baseline in Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS)
From Baseline to Weeks 3, 5, 13, and 25
Cohorts A and B: Change from Baseline in New York Heart Association Functional Class (NYHA FC)
Baseline and Week 25
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort A & B: AZD5462 low doseEXPERIMENTALParticipants will receive low dose of AZD5462 as OD tablets for 24 weeks.
Cohort A & B: AZD5462 medium doseEXPERIMENTALParticipants will receive medium dose of AZD5462 as OD tablets for 24 weeks.
Cohort A & B: AZD5462 high doseEXPERIMENTALParticipants will receive high dose of AZD5462 as OD tablets for 24 weeks.
Cohort A & B: PlaceboEXPERIMENTALParticipants will receive matching placebo OD tablets for 24 weeks.
Interventions
NameTypeDescription
AZD5462DRUGParticipants will receive low, medium \& high doses of film-coated tablets of AZD5462 OD orally.
PlaceboDRUGParticipants will receive matching doses of film-coated tablets of Placebo OD orally.
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites56

Inclusion Criteria: * Participants must have a pre-existing diagnosis of HF NYHA FC II to IV. * Participants must be on stable HF standard of care medication for at least 4 weeks prior to consent and during the Screening period. * Minimum body mass index (BMI) of 18 kilograms per meter square (kg/m...

Countries:United StatesBulgariaCzechiaDenmarkHungaryIndiaJapanNetherlandsPolandSlovakia
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