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Baxdrostat and dapagliflozin

Phase 3

Heart Failure | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Jul 31, 2026

Target and mechanism

ModalitySmall molecule

Also known as Baxdrostat, baxdrostat 2mg, baxdrostat

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment11,300

FDA Designations

No designations recorded

Clinical trial landscape

Baxdrostat and dapagliflozin · 1 trial · 1 indication

Phase 3 1
NCT06677060Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With DapagliflozinHeart Failure
RECRUITING11,300 Analytics
PHASE3RECRUITING
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of an HF event or CV death
Event driven; Up to 38 months

Time to first occurrence of any of the components of the composite of: * Hospitalisation for HF * HF without hospitalisation * CV death

Secondary Endpoints

To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of hospitalisation for HF or CV death
Event driven; Up to 38 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of HF events
Event driven; Up to 38 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of CV death
Event driven; Up to 38 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Baxdrostat/DapagliflozinEXPERIMENTALParticipants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.
Placebo/DapagliflozinEXPERIMENTALPatients will receive a dose of dapagliflozin in combination with matching placebo

Interventions

NameTypeDescription
Baxdrostat and dapagliflozinDRUGbaxdrostat tablet and dapagliflozin tablet
Placebo and dapagliflozinOTHERplacebo tablet and dapagliflozin tablet
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites953

Inclusion Criteria: * Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consent. * Diagnosed with T2DM and requiring treatment * Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease) * History of HTN and an...

Countries:United StatesArgentinaAustraliaBrazilBulgariaCanadaChinaCzechiaDenmarkFranceGermanyGreeceHungaryIndiaIsraelItalyJapanMalaysiaMexicoNetherlandsPeruPhilippinesPolandRomaniaSlovakiaSouth AfricaSouth KoreaSpainSwedenTaiwanThailandTurkey (Türkiye)UkraineUnited KingdomVietnam
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Recent Changes (Last 90 Days)

LOWJul 31, 2026NCT06677060lastUpdatePostDate: changed
LOWJul 31, 2026NCT06677060lastUpdatePostDate: changed

Frequently asked questions about Baxdrostat and dapagliflozin

What is Baxdrostat used for?

Baxdrostat is an investigational small molecule being studied for uncontrolled hypertension and resistant hypertension, as well as for cardiac remodeling, heart failure, chronic kidney disease with hypertension, and primary hyperaldosteronism. It is being evaluated in Phase 3 clinical trials for hypertension indications.

How does Baxdrostat work?

Baxdrostat is a small molecule that targets aldosterone synthase, the enzyme responsible for aldosterone production. By inhibiting this enzyme, it aims to reduce aldosterone levels, which may help lower blood pressure in patients with hypertension, including those with resistant hypertension.

Who makes Baxdrostat?

Baxdrostat is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the drug's efficacy and safety in patients with hypertension and related conditions.

What phase is Baxdrostat in?

Baxdrostat is in Phase 3 clinical development for uncontrolled hypertension and resistant hypertension. It is also being studied in earlier phase trials for related conditions. Baxdrostat is investigational and has not been approved by regulatory authorities for any use.

What clinical trials is Baxdrostat in?

Baxdrostat has been studied in several clinical trials, including NCT06034743 and NCT06344104, both Phase 3 trials in patients with uncontrolled hypertension on two or more medications, including those with resistant hypertension. A Phase 2 trial, NCT06336356, evaluated cortisol reserve following treatment. A Phase 3b trial, NCT07686120, is planned in Chinese participants with uncontrolled hypertension.

Is Baxdrostat the same as Baxdrostat/dapagliflozin?

Baxdrostat is also known as Baxdrostat/dapagliflozin, baxdrostat 2mg, and Baxdrostat and dapagliflozin. These names refer to the same drug, baxdrostat, which is being studied alone or in combination with dapagliflozin for hypertension and related conditions.