Primary completion· ClinicalTrials.gov
A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Particip
Baxdrostat History and Updates
52 events · 2020 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
1
FDA Approvals
0
Label Revisions
49
Trial Milestones
2
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-03Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Baxdrostat since 2020, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (7)
2026
- FDA approvalBaxfendy (baxdrostat) receives initial FDA approval· May 15, 2026
- Pivotal publicationBaxdrostat Phase 3 Trial Publication Shows Effect on Resistant Hypertension· Jan 1, 2026
2025
- Results postedBaxdrostat: No Abnormal Cortisol Response in Uncontrolled Hypertension Study· Dec 17, 2025
- Primary completionBaxdrostat Phase 3 Trial for Hypertension Completes Primary Phase· Nov 24, 2025
- Primary completionBaxdrostat Phase 3 Trial for Resistant Hypertension Reaches Primary Completion· Aug 17, 2025
- Primary completionBaxdrostat Phase 3 Study for Uncontrolled Hypertension Completes Primary Data…· May 21, 2025
- Pivotal publicationBaxdrostat Efficacy and Safety Data Published for Resistant Hypertension· Jan 1, 2025
Upcoming & expected milestones
Primary completion· ClinicalTrials.gov
A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism
Primary completion· ClinicalTrials.gov
A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants
Primary completion· ClinicalTrials.gov
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
Primary completion· ClinicalTrials.gov
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapag
Past events
2026
FDA approval· FDA
Sponsor: ASTRAZENECA PHARMS. Class: Type 1 - New Molecular Entity.
Pivotal publication· PubMed
Bax24 — A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
2025
Results posted· ClinicalTrials.gov
A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compa
Trial started· ClinicalTrials.gov
A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Particip
Primary completion· ClinicalTrials.gov
A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Inclu
Trial registered· ClinicalTrials.gov
A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Particip
Primary completion· ClinicalTrials.gov
A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
Trial started· ClinicalTrials.gov
A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism
Trial registered· ClinicalTrials.gov
A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism
Primary completion· ClinicalTrials.gov
A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Inclu
Trial started· ClinicalTrials.gov
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
Trial started· ClinicalTrials.gov
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapag
Primary completion· ClinicalTrials.gov
A Study to Investigate the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel When Given Alone and in Combination With Baxdrostat in H
Pivotal publication· PubMed
BaxHTN — A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
2024
Trial registered· ClinicalTrials.gov
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapag
Primary completion· ClinicalTrials.gov
A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compa
Trial registered· ClinicalTrials.gov
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
Trial started· ClinicalTrials.gov
A Study to Investigate the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel When Given Alone and in Combination With Baxdrostat in H
Trial registered· ClinicalTrials.gov
A Study to Investigate the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel When Given Alone and in Combination With Baxdrostat in H
Primary completion· ClinicalTrials.gov
A Study to Investigate the Pharmacokinetics of Baxdrostat When Given Alone and in Combination With Itraconazole in Healthy Participants
Trial started· ClinicalTrials.gov
A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compa
Primary completion· ClinicalTrials.gov
A Study to Investigate the Effect on QTcF of Baxdrostat Compared With Placebo, Using Moxifloxacin as a Positive Control, in Healthy Particip
Trial started· ClinicalTrials.gov
A Study to Investigate the Pharmacokinetics of Baxdrostat When Given Alone and in Combination With Itraconazole in Healthy Participants
Trial registered· ClinicalTrials.gov
A Study to Investigate the Pharmacokinetics of Baxdrostat When Given Alone and in Combination With Itraconazole in Healthy Participants
Trial started· ClinicalTrials.gov
A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Inclu
Trial registered· ClinicalTrials.gov
A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Inclu
Trial started· ClinicalTrials.gov
A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants
Trial registered· ClinicalTrials.gov
A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compa
Trial started· ClinicalTrials.gov
A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
Trial started· ClinicalTrials.gov
A Study to Investigate the Effect on QTcF of Baxdrostat Compared With Placebo, Using Moxifloxacin as a Positive Control, in Healthy Particip
Trial registered· ClinicalTrials.gov
A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants
Trial registered· ClinicalTrials.gov
A Study to Investigate the Effect on QTcF of Baxdrostat Compared With Placebo, Using Moxifloxacin as a Positive Control, in Healthy Particip
2023
Trial registered· ClinicalTrials.gov
A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
Trial started· ClinicalTrials.gov
A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Inclu
Trial registered· ClinicalTrials.gov
A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Inclu
Trial registered· ClinicalTrials.gov
Baxdrostat Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Japanese Population
Trial registered· ClinicalTrials.gov
Phase 1 Study to Determine the Metabolism and Clearance of Baxdrostat
Trial registered· ClinicalTrials.gov
Phase 1 PK Study to Evaluate the PK of CIN-107 in Subjects With Hepatic Impairment
Trial registered· ClinicalTrials.gov
Baxdrostat Bioavailability and Bioequivalence Study
2022
Primary completion· ClinicalTrials.gov
Baxdrostat Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Japanese Population
Trial started· ClinicalTrials.gov
Baxdrostat Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Japanese Population
Primary completion· ClinicalTrials.gov
Phase 1 PK Study to Evaluate the PK of CIN-107 in Subjects With Hepatic Impairment
Primary completion· ClinicalTrials.gov
Phase 1 Study to Determine the Metabolism and Clearance of Baxdrostat
2021
Trial started· ClinicalTrials.gov
Phase 1 Study to Determine the Metabolism and Clearance of Baxdrostat
Trial started· ClinicalTrials.gov
Phase 1 PK Study to Evaluate the PK of CIN-107 in Subjects With Hepatic Impairment
2020
Primary completion· ClinicalTrials.gov
Baxdrostat Bioavailability and Bioequivalence Study
Trial started· ClinicalTrials.gov
Baxdrostat Bioavailability and Bioequivalence Study
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.