Drugs / Baxdrostat
Baxdrostat
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | BAXFENDY | — | 2026-05-15 | fda.gov ↗ |
Trials 24 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT06657105 | Nov 2024 → Feb 2025 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT06357520 | Apr → Jun 2024 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT06194032 | Feb → May 2024 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05966324 | Jul → Sep 2022 | hypertensive disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05961384 | Nov 2021 → Jan 2022 | hypertensive disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05961397 | Aug 2021 → Apr 2022 | hypertensive disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05470725 | Jan → Apr 2021 | hypertensive disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05526690 | Oct → Dec 2020 | hypertensive disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05500820 | Dec 2019 → Apr 2020 | hypertensive disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01995383 | Nov 2013 → Jun 2014 | atherosclerosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT06336356 | Jun → Dec 2024 | hypertensive disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT05432167 | Apr 2022 → May 2024 | chronic kidney disease, hypertensive disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT05459688 | Apr 2022 → Nov 2023 | hypertensive disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT05137002 | Dec 2021 → Sep 2022 | hypertensive disorder | CinCor Pharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04605549 | Mar 2021 → Oct 2024 | primary aldosteronism | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT04519658 | Oct 2020 → Jun 2022 | resistant hypertension | CinCor Pharma, Inc. | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT07686120 | Sep 2026 → Feb 2028 expected | hypertensive disorder | AstraZeneca | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07007793 | Aug 2025 → Aug 2027 expected | primary aldosteronism | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06677060 | Mar 2025 → Dec 2029 expected | heart failure | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06742723 | Mar 2025 → Dec 2029 expected | chronic kidney disease | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06344104 | Apr 2024 → Nov 2025 | resistant hypertension | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT06268873 | Mar 2024 → Feb 2028 expected | chronic kidney disease | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06168409 | Mar 2024 → Aug 2025 | resistant hypertension | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT06034743 | Nov 2023 → May 2025 | resistant hypertension | AstraZeneca | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT07222917 Background | Dec 2025 → May 2027 expected | chronic kidney disease | AstraZeneca | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07655362 Comparator | Jun 2026 → Jun 2028 expected | — | Subodh Verma | Not yet recruiting | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-12-02 | AstraZeneca | Baxdrostat New Drug Application accepted under FDA Priority Review in the US for patients with hard-to-control hypertension astrazeneca.com ↗ |
| 2025-11-09 | AstraZeneca | Baxdrostat demonstrated a statistically significant and highly clinically meaningful placebo-adjusted reduction of 14.0 mmHg in 24-hour ambulatory systolic blood pressure in patients with resistant hypertension in the Bax24 Phase III trial astrazeneca.com ↗ |
| 2025-10-07 | AstraZeneca | Baxdrostat met the primary endpoint in Bax24 Phase III trial in patients with resistant hypertension astrazeneca.com ↗ |
| 2025-08-30 | AstraZeneca | 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.com ↗ |
| 2025-07-14 | AstraZeneca | Baxdrostat met the primary and all secondary endpoints in BaxHTN Phase III trial in patients with uncontrolled or treatment resistant hypertension astrazeneca.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Baxdrostat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06742723 ↗ |
| Known as | Baxdrostat CIN-107 | “Baxdrostat CIN-107” NCT06677060 ↗1“Baxdrostat CIN-107” NCT06742723 ↗ |
| Known as | Baxfendy | “Participants will take 2mg baxdrostat (Baxfendy) once daily (orally), in addition to standard-of-care.” NCT07655362 ↗ |
| Known as | CIN-107 | “The goal of this study is to compare the characteristics of baxdrostat (CIN-107) in terms of baxdrostat levels over time in the blood in healthy Japanese and Caucasian...” NCT05966324 ↗ |
| Known as | RO6836191 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01995383 ↗ |
| Action | Inhibit | “We now report the development of RO6836191 as a potent (Ki 13 nmol/L) competitive inhibitor of AS, with in vitro selectivity >100-fold over 11β-hydroxylase.” PMID 27872236 ↗ Nov 2016 |
| Modality | Small molecule | — CHEMBL4113975 ↗ |
| Route | Oral | “Orally administered, single ascending doses” NCT01995383 ↗ |