Approval Probability
TA Base Rate
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ML Risk
Also known as Baxdrostat, baxdrostat 2mg, baxdrostat, Baxdrostat and dapagliflozin
Baxdrostat/dapagliflozin · 3 trials · 1 indication
Time to the first occurrence of any of the components of the composite of: Kidney disease progression * ≥ 50% sustained decline in eGFR * Onset of kidney failure: * Sustained eGFR \< 15 mL/min/1.73 m2 or * Chronic dialysis treatment or * Receiving a kidney transplant or * Death with a renal primary cause (death due to kidney failure when dialysis is not given) CV events * HF with or without hospitalisation * CV death
Change from baseline in eGFR to post treatment.
Change from baseline in UACR
| Arm | Type | Description |
|---|---|---|
| Baxdrostat/dapagliflozin | EXPERIMENTAL | Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a lower dose of baxdrostat and standard dose dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose. |
| Placebo/dapagliflozin | PLACEBO_COMPARATOR | Patients will receive one dose of dapagliflozin comparator in combination with matching placebo daily. |
| Dapagliflozin | ACTIVE_COMPARATOR | Patients will receive one dose of dapagliflozin (active comparator) in combination with placebo matching baxdrostat daily |
| Baxdrostat /placebo | PLACEBO_COMPARATOR | Patients will receive one dose of baxdrostat comparator in combination with placebo matching dapagliflozin daily |
| Name | Type | Description |
|---|---|---|
| Baxdrostat/dapagliflozin | DRUG | baxdrostat tablet dapagliflozin tablet |
| Placebo/dapagliflozin | DRUG | dapagliflozin tablet placebo tablet |
| Dapagliflozin in combination with placebo | DRUG | dapagliflozin tablet placebo tablet |
| Baxdrostat/Placebo | DRUG | baxdrostat tablet placebo tablet |
Inclusion Criteria: 1. Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent. 2. Participants with (a) or (b): a) eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND: * UACR ≥ 30 mg/g (3.39 mg/mmol) and \< 500 mg/g (56.5 mg/mmo...
Baxdrostat is an investigational small molecule being studied for uncontrolled hypertension and resistant hypertension, as well as for cardiac remodeling, heart failure, chronic kidney disease with hypertension, and primary hyperaldosteronism. It is being evaluated in Phase 3 clinical trials for hypertension indications.
Baxdrostat is a small molecule that targets aldosterone synthase, the enzyme responsible for aldosterone production. By inhibiting this enzyme, it aims to reduce aldosterone levels, which may help lower blood pressure in patients with hypertension, including those with resistant hypertension.
Baxdrostat is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the drug's efficacy and safety in patients with hypertension and related conditions.
Baxdrostat is in Phase 3 clinical development for uncontrolled hypertension and resistant hypertension. It is also being studied in earlier phase trials for related conditions. Baxdrostat is investigational and has not been approved by regulatory authorities for any use.
Baxdrostat has been studied in several clinical trials, including NCT06034743 and NCT06344104, both Phase 3 trials in patients with uncontrolled hypertension on two or more medications, including those with resistant hypertension. A Phase 2 trial, NCT06336356, evaluated cortisol reserve following treatment. A Phase 3b trial, NCT07686120, is planned in Chinese participants with uncontrolled hypertension.
Baxdrostat is also known as Baxdrostat/dapagliflozin, baxdrostat 2mg, and Baxdrostat and dapagliflozin. These names refer to the same drug, baxdrostat, which is being studied alone or in combination with dapagliflozin for hypertension and related conditions.