AstraZeneca Launches Phase III Trial of Baxdrostat Tablets for Primary Aldosteronism

Data from the Drug Clinical Trial Registry and Information Disclosure Platform show that a Phase III clinical trial has been initiated by AstraZeneca AB/AstraZeneca Global R&D (China) Co., Ltd./Patheon Pharmaceuticals, Inc. This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Baxdrostat in adult subjects with primary aldosteronism. The clinical trial registration number is CTR20253544, and the initial information disclosure date was September 3, 2025.

The drug formulation is tablets, administered orally, with a dosage of 2 tablets per day for a treatment duration of 52 weeks. The primary objective of this trial is to evaluate the efficacy and safety of baxdrostat compared to placebo in subjects with primary aldosteronism.

Baxdrostat Tablets are a chemical drug indicated for primary aldosteronism. Primary aldosteronism is characterized by excessive secretion of aldosterone from the adrenal cortex, leading to water and sodium retention and increased blood volume, manifesting as hypertension and hypokalemia. Diagnosis relies on measurements of blood and urine aldosterone levels and renin activity.

The primary endpoint of this trial was the change in seated SBP from baseline at Week 8; secondary endpoints included the change in seated SBP from RWD baseline (Week 44) at Week 52, the percentage change in PRA from RWD baseline (Week 44) at Week 52, and several other indicators.

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 25 participants in China and 180 participants internationally.

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Editor: Xiaolang Express