Clinical Trials
Multiple Phase I, Phase II, and Phase III clinical trials evaluate Baxdrostat across cardiovascular and renal indications—including uncontrolled and resistant hypertension, primary hyperaldosteronism, chronic kidney disease, and heart failure—alongside pharmacokinetic assessments in healthy participants. Sponsored by pharmaceutical leaders such as AstraZeneca and academic investigators like Queen Mary University of London and Subodh Verma, these studies encompass completed, actively recruiting, and active non-recruiting protocols. Notably, several Phase III clinical trials specifically target resistant hypertension and chronic kidney disease.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06742723 | RECRUITING | Chronic Kidney Disease and Hypertension |
AstraZeneca |
2025-03-03 | PHASE3 |
| NCT06677060 | RECRUITING | Heart Failure |
AstraZeneca |
2025-03-14 | PHASE3 |
| NCT07655362 | NOT_YET_RECRUITING | Cardiac Remodeling |
Subodh Verma |
2026-06-30 | PHASE3 |
| NCT07800858 | NOT_YET_RECRUITING | Primary Aldosteronism |
Queen Mary University of London |
2026-09-15 | |
| NCT06268873 | ACTIVE_NOT_RECRUITING | Chronic Kidney Disease and Hypertension |
AstraZeneca |
2024-03-29 | PHASE3 |
| NCT07686120 | NOT_YET_RECRUITING | Uncontrolled Hypertension |
AstraZeneca |
2026-09-30 | PHASE3 |
| NCT07007793 | RECRUITING | Primary Hyperaldosteronism |
AstraZeneca |
2025-08-07 | PHASE3 |
| NCT07222917 | ACTIVE_NOT_RECRUITING | Chronic Kidney Disease and Hypertension |
AstraZeneca |
2025-12-05 | PHASE2 |
| NCT06344104 | COMPLETED | Uncontrolled Hypertension; Resistant Hypertension |
AstraZeneca |
2024-04-08 | PHASE3 |
| NCT06168409 | COMPLETED | Resistant Hypertension |
AstraZeneca |
2024-03-01 | PHASE3 |
| NCT06034743 | COMPLETED | Uncontrolled Hypertension; Resistant Hypertension |
AstraZeneca |
2023-11-22 | PHASE3 |
| NCT06657105 | COMPLETED | Healthy Participants |
AstraZeneca |
2024-11-01 | PHASE1 |
| NCT06336356 | COMPLETED | Uncontrolled Hypertension |
AstraZeneca |
2024-06-10 | PHASE2 |
| NCT06357520 | COMPLETED | Healthy Participants |
AstraZeneca |
2024-04-16 | PHASE1 |
| NCT06194032 | COMPLETED | Healthy Participants |
AstraZeneca |
2024-02-29 | PHASE1 |
| NCT05966324 | COMPLETED | Hypertension |
AstraZeneca |
2022-07-05 | PHASE1 |
| NCT05961397 | COMPLETED | Hypertension |
AstraZeneca |
2021-08-10 | PHASE1 |
| NCT05961384 | COMPLETED | Hypertension |
AstraZeneca |
2021-11-18 | PHASE1 |
| NCT05963009 | COMPLETED | Hypertension |
AstraZeneca |
2020-03-11 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-08-26)
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).