Baxdrostat

{{Short description|Chemical compound}} {{Use dmy dates|date=November 2025}} {{cs1 config|name-list-style=vanc|display-authors=6}} {{Infobox drug | image = Baxdrostat.svg | image_class = skin-invert-image | width = | alt = | caption = Molecular structure of baxdrostat | image2 = Baxdrostat 3D.png | pronounce = | tradename = Baxfendy | Drugs.com = | MedlinePlus = | DailyMedID = baxdrostat | pregnancy_AU =  | pregnancy_AU_comment = | pregnancy_category = | routes_of_administration = By mouth | caption2 = 3D representation of a baxdrostat molecule | class = | ATC_prefix = C02 | ATC_suffix = KN02 | ATC_supplemental =  | legal_AU =  | legal_AU_comment = | legal_BR =  | legal_BR_comment = | legal_CA =  | legal_CA_comment = | legal_DE =  | legal_DE_comment = | legal_NZ =  | legal_NZ_comment = | legal_UK =  | legal_UK_comment = | legal_US = Rx-only | legal_US_comment = <ref name="Baxfendy FDA label">{{cite web | title=Baxfendy- baxdrostat tablet, film coated | website=DailyMed | date=15 May 2026 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1fc1ee7-facc-4099-b3db-a4c1daeaa4be | access-date=23 May 2026}}</ref> | legal_EU = | legal_EU_comment = | legal_UN =  | legal_UN_comment = | legal_status =

| IUPAC_name = N-[(8R)-4-(1-methyl-2-oxo-1,2,3,4-tetrahydro-6-quinolinyl)-5,6,7,8-tetrahydro-8-isoquinolinyl]propanamide | C = 22 | H = 25 | N = 3 | O = 2 | SMILES = CCC(=O)N[C@@H]1CCCC2=C(C=NC=C12)C3=CC=C4N(C)C(=O)CCC4=C3 | StdInChI = 1S/C22H25N3O2/c1-3-21(26)24-19-6-4-5-16-17(12-23-13-18(16)19)14-7-9-20-15(11-14)8-10-22(27)25(20)2/h7,9,11-13,19H,3-6,8,10H2,1-2H3,(H,24,26)/t19-/m1/s1 | StdInChI_comment = | StdInChIKey = VDEUDSRUMNAXJG-LJQANCHMSA-N | density = | density_notes = | melting_point = | melting_high = | melting_notes = | boiling_point = | boiling_notes = | solubility = | sol_units = | specific_rotation = }}

'''Baxdrostat''', sold under the brand name '''Baxfendy''', is a medication used for the treatment of hypertension (high blood pressure).<ref name="Baxfendy FDA label" /> It is an aldosterone synthase inhibitor.<ref name="Baxfendy FDA label" /> It is taken by mouth.<ref name="Baxfendy FDA label" />

Baxdrostat was approved for medical use in the United States in May 2026.<ref name="Novel Drug Approvals for 2026">{{cite web | title=Novel Drug Approvals for 2026 | website=U.S. Food and Drug Administration (FDA) | date=18 May 2026 | url=https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026 | access-date=23 May 2026}}</ref>

== 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.<ref name="Baxfendy FDA label" />

== Mechanism of action == Aldosterone dysregulation contributes significantly to the pathogenesis of resistant hypertension.<ref>{{cite journal | vauthors = Acelajado MC, Calhoun DA | title = Aldosteronism and resistant hypertension | journal = International Journal of Hypertension | volume = 2011 | article-number = 837817 | date = January 2011 | pmid = 21331160 | pmc = 3034938 | doi = 10.4061/2011/837817 | doi-access = free }}</ref> While conventional drugs act by blocking the mineralocorticoid receptor, baxdrostat, an aldosterone synthase inhibitor, targets the aldosterone synthesis directly.<ref name="Dogra_2023">{{cite journal | vauthors = Dogra S, Shah S, Gitzel L, Pusukur B, Sood A, Vyas AV, Gupta R | title = Baxdrostat: A Novel Aldosterone Synthase Inhibitor for Treatment Resistant Hypertension | journal = Current Problems in Cardiology | volume = 48 | issue = 11 | date = November 2023 | pmid = 37399857 | doi = 10.1016/j.cpcardiol.2023.101918 | s2cid = 259320969 | article-number = 101918 }}</ref>

== 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.<ref>{{cite journal | vauthors = Freeman MW, Halvorsen YD, Marshall W, Pater M, Isaacsohn J, Pearce C, Murphy B, Alp N, Srivastava A, Bhatt DL, Brown MJ | title = Phase 2 Trial of Baxdrostat for Treatment-Resistant Hypertension | journal = The New England Journal of Medicine | volume = 388 | issue = 5 | pages = 395–405 | date = February 2023 | pmid = 36342143 | doi = 10.1056/NEJMoa2213169 }}</ref>

==== BaxHTN ==== BaxHTN is a phase III trial.<ref name="Flack_2025">{{cite journal | vauthors = Flack JM, Azizi M, Brown JM, Dwyer JP, Fronczek J, Jones ES, Olsson DS, Perl S, Shibata H, Wang JG, Wilderäng U, Wittes J, Williams B | title = Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension | journal = The New England Journal of Medicine | volume = 393 | issue = 14 | pages = 1363–1374 | date = October 2025 | pmid = 40888730 | pmc = 7618089 | doi = 10.1056/NEJMoa2507109 }}</ref> 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.<ref>{{cite press release | title=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 | website=AstraZeneca | date=30 August 2025 | url=https://www.astrazeneca-us.com/media/press-releases/2025/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.html | access-date=23 May 2026}}</ref><ref name="Flack_2025" />

== Society and culture == === Legal status === Baxdrostat was approved for medical use in the United States in May 2026.<ref name="Novel Drug Approvals for 2026" /><ref>{{cite press release | title=Baxfendy approved in the US as the first and only aldosterone synthase inhibitor treatment for adults with hypertension | website=AstraZeneca | date=18 May 2026 | url=https://www.astrazeneca.com/media-centre/press-releases/2026/Baxdrostat-MNR-2026.html | access-date=23 May 2026}}</ref>

=== Names === Baxdrostat is the international nonproprietary name.<ref>{{cite journal | vauthors = ((World Health Organization)) | year = 2022 | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 87 | journal = WHO Drug Information | volume = 36 | issue = 1 | hdl = 10665/352794 | hdl-access = free | author-link = World Health Organization }}</ref>

Baxdrostat is sold under the brand name Baxfendy.<ref name="Baxfendy FDA label" />

== References == {{Reflist}}

== Further reading == * {{cite journal | vauthors = Sato A, Nishimoto M | title = Aldosterone synthase inhibitors: a new option for antihypertensive, cardio-renal protection | journal = Hypertension Research | volume = | issue = | pages = | date = May 2026 | pmid = 42162198 | doi = 10.1038/s41440-026-02671-z | doi-access = free | title-link = doi }}

== External links == * {{ClinicalTrialsGov|NCT06034743|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)}} * {{ClinicalTrialsGov|NCT04519658|A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN) (BrigHTN)}} * {{ClinicalTrialsGov|NCT06168409|A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension (Bax24)}}

Category:Tetrahydroisoquinolines Category:Lactams Category:Amides Category:Tetrahydroquinolines Category:Aldosterone synthase inhibitors