Baxdrostat: First Approval

Gao Y, Mu X, Pang X. Efficacy and safety of aldosterone synthase inhibitors for uncontrolled hypertension: a meta-analysis of randomized controlled trials and systematic review. Front Pharmacol. 2025;16:1664810.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Carey RM, Calhoun DA, Bakris GL, et al. Resistant hypertension: detection, evaluation, and management: a scientific statement from the American Heart Association. Hypertension. 2018;72(5):e53–90.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Qureshi AJ, Tagga MRT, Khan AQ. Baxdrostat and aldosterone synthase inhibitors: a new class for treatment-resistant hypertension. Cardiovasc Drugs Ther. 2026. https://doi.org/10.1007/s10557-026-07887-2.

Article  PubMed  Google Scholar 

Park S. Emergence of aldosterone synthase inhibitors for treatment of difficult to treat hypertension. Hypertens Res. 2026;49(3):579–80.

Article  CAS  PubMed  Google Scholar 

AstraZeneca. BAXFENDY™ (baxdrostat) tablets, for oral use: US prescribing information. 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219878Orig1s000lbl.pdf. Accessed 21 Jul 2026.

AstraZeneca. Baxfendy approved in the US as the first and only aldosterone synthase inhibitor treatment for adults with hypertension [media release]. 18 May 2026. https://www.astrazeneca.com/media-centre/press-releases/2026/Baxdrostat-MNR-2026.html.

U.S. Food & Drug Administration. Drug approval package: BAXFENDY. 2026. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/219878Orig1s000TOC.html. Accessed 21 Jul 2026.

AstraZeneca. Baxdrostat New Drug Application accepted under FDA Priority Review in the US for patients with hard-to-control hypertension [media release]. 2 Dec 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/baxdrostat-new-drug-application-accepted-under-fda-priority-review-in-the-us-for-patients-with-hard-to-control-hypertension.html.

CinCor Pharma. CinCor Pharma in-licenses aldosterone synthase inhibitor, CIN-107, and closes $50 million Series A financing [media release]. 14 May 2019. https://5amventures.com/wp-content/uploads/2019/05/CinCor-Pharma-In-Licenses-Aldosterone-Synthase-Inhibitor-CIN-107-and-Closes-50-Million-Series-A-Financing.pdf.

AstraZeneca. Acquisition of CinCor Pharma complete [media release]. 24 Feb 2023. https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-acquires-cincor-for-cardiorenal-asset.html#.

Freeman MW, Bond M, Murphy B, et al. Results from a phase 1, randomized, double-blind, multiple ascending dose study characterizing the pharmacokinetics and demonstrating the safety and selectivity of the aldosterone synthase inhibitor baxdrostat in healthy volunteers. Hypertens Res. 2023;46(1):108–18.

Article  CAS  PubMed  Google Scholar 

Freeman MW, Halvorsen YD, Marshall W, et al. Phase 2 trial of baxdrostat for treatment-resistant hypertension. N Engl J Med. 2023;388(5):395–405.

Article  CAS  PubMed  Google Scholar 

Fisher NDL, Zhou W, Olsson D, et al. Effect of baxdrostat on cortisol responsiveness in participants with uncontrolled hypertension: a phase II randomized controlled trial [abstract no 26-A-9902-ACC]. J Am Coll Cardiol. 2026;87(13, Suppl 7):A263–4.

Article  Google Scholar 

Sunnåker M, Källgren C, Parkinson J, et al. No evidence of QTc interval prolongation with baxdrostat treatment: concentration-QTc modeling assessment. Pharmacol Res Perspect. 2025;13(e70181):1–11.

Google Scholar 

Freeman MW, Halvorsen YD, Bond M, et al. Results from a phase 1 study assessing the pharmacokinetics of the aldosterone synthase inhibitor baxdrostat in participants with varying degrees of renal function. Clin Pharmacol Drug Dev. 2024;13(4):410–8.

Article  CAS  PubMed  Google Scholar 

Flack JM, Azizi M, Brown JM, et al. Efficacy and safety of baxdrostat in uncontrolled and resistant hypertension. N Engl J Med. 2025;393(14):1363–74.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Azizi M, Brown JM, Dwyer JP, et al. Effect of baxdrostat on ambulatory blood pressure in patients with resistant hypertension (Bax24): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2026;407(10532):988–99.

Article  CAS  PubMed  Google Scholar 

CinCor Pharma. CinCor Pharma announces topline data for phase 2 HALO trial evaluating selective aldosterone synthase inhibitor baxdrostat in uncontrolled hypertension [media release]. 28 Nov 2022. https://www.globenewswire.com/news-release/2022/11/28/2563048/0/en/cincor-pharma-announces-topline-data-for-phase-2-halo-trial-evaluating-selective-aldosterone-synthase-inhibitor-baxdrostat-in-uncontrolled-hypertension.html.

American College of Cardiology. Efficacy and safety of baxdrostat in patients with uncontrolled hypertension - HALO. 2023. https://www.acc.org/Latest-in-Cardiology/Clinical-Trials/2023/03/01/23/34/halo. Accessed 21 Jul 2026.

Dwyer JP, Maklad N, Vedin O, et al. Efficacy and safety of baxdrostat in participants with CKD and uncontrolled hypertension: a randomized, double-blind, placebo-controlled trial. J Am Soc Nephrol. 2026;37(2):299–311.

Article  PubMed  Google Scholar 

Turcu AF, Freeman MW, Bancos I, et al. Phase 2a study of baxdrostat in primary aldosteronism. N Engl J Med. 2025;393(5):515–8.

Article  PubMed  Google Scholar 

National Institutes of Health. NCT06742723. 2022. https://clinicaltrials.gov/study/NCT06742723. Accessed 21 Jul 2026.

National Institutes of Health. NCT06268873. 2024. https://clinicaltrials.gov/study/NCT06268873. Accessed 21 Jul 2026.

National Institutes of Health. NCT07222917. 2025. https://clinicaltrials.gov/study/NCT07222917. Accessed 21 Jul 2026.

National Institutes of Health. NCT06677060. 2024. https://clinicaltrials.gov/study/NCT06677060. Accessed 21 Jul 2026.

National Institutes of Health. NCT07007793. 2025. https://clinicaltrials.gov/study/NCT07007793. Accessed 21 Jul 2026.

Comments (0)

No login
gif