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Baxdrostat

Phase 3

Primary Hyperaldosteronism | Small molecule | Other |AstraZeneca PLC|Last Updated: Apr 20, 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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment250
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07007793A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary AldosteronismPHASE3 RECRUITING 250 — — Aug 7, 2025Feb 18, 2028Apr 20, 202689 United States, Australia +10
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Study Endpoints
Primary Endpoints
Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8
At week 8

To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) at Week 8

Achieving normalization of the Renin Angiotensin Aldosterone system (RAAS) at week 8
At week 8

To assess the effect of baxdrostat versus placebo on achieving normalization of the Renin Angiotensin Aldosterone system (RAAS) at week 8, in participants with dysregulated RAAS at baseline

Secondary Endpoints
Change from Randomised withdrawal (RWD) baseline (Week 44) in seated Systolic Blood Pressure (SBP) at Week 52
At week 52
Percent change from RWD baseline (Week 44) in Plasma Renin Activity (PRA) at Week 52
At week 52
Achieving serum potassium ≥ 3.7 mmol/L without potassium supplementation at Week 8 in participants with serum potassium < 3.7 mmol/L or potassium supplementation at baseline
At week 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BaxdrostatEXPERIMENTALBaxdrostat administered orally, once daily (QD).
PlaceboPLACEBO_COMPARATORMatching placebo administered orally, once daily (QD).
Interventions
NameTypeDescription
BaxdrostatDRUGBaxdrostat tablet administered orally, once daily (QD).
PlaceboDRUGPlacebo tablet matching baxdrostat, administered orally, once daily (QD).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites89

Inclusion Criteria: * Male or female participants must be ≥ 18 years of age * Participants with a documented diagnosis of PA that fulfils the criteria defined in the 2016 or 2025 Endocrine Society Guidelines. * Participants willing and able to cease dosing of MRA or potassium sparing diuretics per ...

Countries:United StatesAustraliaCanadaChinaFranceGermanyIndiaItalyJapanSpainTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07007793Enrollment: 180 → 250
LOWMay 24, 2026NCT07007793studyFirstPostDate: changed