![]() Molecular structure of baxdrostat | |
3D representation of a baxdrostat molecule | |
| Clinical data | |
|---|---|
| Trade names | Baxfendy |
| Other names | RO-6836191 |
| License data |
|
| Routes of administration | By mouth |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| |
| CAS Number | |
| PubChem CID | |
| IUPHAR/BPS | |
| ChemSpider | |
| UNII | |
| KEGG | |
| ChEMBL | |
| Chemical and physical data | |
| Formula | C22H25N3O2 |
| Molar mass | 363.461 g·mol−1 |
| 3D model (JSmol) | |
| |
| |
Baxdrostat, sold under the brand name Baxfendy, is a medication used for the treatment of hypertension (high blood pressure).1 It is an aldosterone synthase inhibitor.1 It is taken by mouth.1
Baxdrostat was approved for medical use in the United States in May 2026.2
Medical uses
Baxdrostat is indicated for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adults who are not adequately controlled on other agents.1
Mechanism of action
Aldosterone dysregulation contributes significantly to the pathogenesis of resistant hypertension.3 While conventional drugs act by blocking the mineralocorticoid receptor, baxdrostat, an aldosterone synthase inhibitor, targets the aldosterone synthesis directly.4
History
Clinical trials
BrigHTN
In adults with treatment-resistant hypertension, treatment with baxdrostat at doses of 1 mg or 2 mg daily produced significantly greater reductions in systolic blood pressure over 12 weeks compared to placebo.5
BaxHTN
BaxHTN is a phase III trial.6 It found that adding once-daily baxdrostat to standard antihypertensive therapy led to significantly greater reductions in seated systolic blood pressure at 12 weeks compared with placebo, in adults with uncontrolled or resistant hypertension.76
Society and culture
Legal status
Baxdrostat was approved for medical use in the United States in May 2026.28
Names
Baxdrostat is the international nonproprietary name.9
Baxdrostat is sold under the brand name Baxfendy.1
References
References
- "Baxfendy- baxdrostat tablet, film coated". DailyMed. 15 May 2026. Retrieved 23 May 2026.
- "Novel Drug Approvals for 2026". U.S. Food and Drug Administration (FDA). 18 May 2026. Retrieved 23 May 2026.
- Acelajado MC, Calhoun DA (January 2011). "Aldosteronism and resistant hypertension". International Journal of Hypertension. 2011 837817. doi:10.4061/2011/837817. PMC 3034938. PMID 21331160.
- Dogra S, Shah S, Gitzel L, Pusukur B, Sood A, Vyas AV, et al. (November 2023). "Baxdrostat: A Novel Aldosterone Synthase Inhibitor for Treatment Resistant Hypertension". Current Problems in Cardiology. 48 (11) 101918. doi:10.1016/j.cpcardiol.2023.101918. PMID 37399857. S2CID 259320969.
- Freeman MW, Halvorsen YD, Marshall W, Pater M, Isaacsohn J, Pearce C, et al. (February 2023). "Phase 2 Trial of Baxdrostat for Treatment-Resistant Hypertension". The New England Journal of Medicine. 388 (5): 395–405. doi:10.1056/NEJMoa2213169. PMID 36342143.
- Flack JM, Azizi M, Brown JM, Dwyer JP, Fronczek J, Jones ES, et al. (October 2025). "Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension". The New England Journal of Medicine. 393 (14): 1363–1374. doi:10.1056/NEJMoa2507109. PMC 7618089. PMID 40888730.
- "Baxdrostat demonstrated statistically significant and clinically meaningful reduction in systolic blood pressure in patients with hard-to-control hypertension in the BaxHTN Phase III trial". AstraZeneca (Press release). 30 August 2025. Retrieved 23 May 2026.
- "Baxfendy approved in the US as the first and only aldosterone synthase inhibitor treatment for adults with hypertension". AstraZeneca (Press release). 18 May 2026. Retrieved 23 May 2026.
- World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 87". WHO Drug Information. 36 (1). hdl:10665/352794.
Further reading
Further reading
- Sato A, Nishimoto M (May 2026). "Aldosterone synthase inhibitors: a new option for antihypertensive, cardio-renal protection". Hypertension Research. doi:10.1038/s41440-026-02671-z. PMID 42162198.
External links
External links
- Clinical trial number NCT06034743 for "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 (BaxHTN)" at ClinicalTrials.gov
- Clinical trial number NCT04519658 for "A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN) (BrigHTN)" at ClinicalTrials.gov
- Clinical trial number NCT06168409 for "A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension (Bax24)" at ClinicalTrials.gov
