Recently, Salubris received a Clinical Trial Approval Notice issued by NMPA, permitting the company to initiate clinical trials for its self-developed innovative small-molecule drug SAL0140 tablets (project code: SAL0140) for the treatment of uncontrolled hypertension.
SAL0140 is an aldosterone synthase inhibitor with proprietary intellectual property rights held by Salubris. The intended indications include uncontrolled hypertension (including refractory hypertension) and related conditions.
Aldosterone, the body’s most critical mineralocorticoid, plays a significant role in hypertension and associated diseases by binding to the mineralocorticoid receptor (MR). It promotes sodium retention and potassium excretion in the kidneys and may mediate or accelerate vascular inflammation and fibrosis through the damaging effects of angiotensin II (Ang II) [1].
Studies indicate that aldosterone not only activates MR-mediated genomic signaling pathways but may also trigger end-organ damage via non-MR-mediated non-genomic pathways [2]. Aldosterone synthase inhibitors hold therapeutic potential by suppressing aldosterone synthesis, thereby reducing blood pressure while mitigating end-organ damage caused by both genomic and non-genomic effects.
Preclinical studies demonstrate that SAL0140 selectively inhibits aldosterone synthase activity and effectively curbing aldosterone production without affecting cortisol levels. In hypertensive primate models, SAL0140 significantly suppressed aldosterone synthesis and achieved stable blood pressure control with once-daily dosing [2].
Hypertension often arises from multiple interacting factors and involves complex pathogenic mechanisms. Salubris remains committed to exploring innovative solutions to deliver exceptional blood pressure-lowering and stabilizing therapies. If successfully developed and approved, SAL0140 could provide a novel treatment option for patients in specific hypertension subpopulations.
Regarding Resistant Hypertension
Resistant hypertension [1] is diagnosed when all of the following criteria are met despite intensive lifestyle interventions: Concurrent use of three antihypertensive agents of different classes (including a thiazide diuretic) for ≥4 weeks, with each medication administered at the maximum dose or maximum tolerated dose by the patient; Clinic blood pressure remains ≥140/90 mmHg and either 24-hour average ambulatory blood pressure ≥130/80 mmHg, or home blood pressure average ≥135/85 mmHg, or blood pressure is only controlled with ≥4 antihypertensive agents .
References:
[1] Chinese Guidelines for the Prevention and Treatment of Hypertension (2024 Revision).
[2] Announcement by Shenzhen Salubris Pharmaceuticals Regarding the Approval of Clinical Trial for SAL0140.
Disclaimer:
1. This material aims to enhance disease awareness and knowledge and is not intended for advertising purposes.
2. The information provided herein is for reference only. Always follow the advice or guidance of a physician or other healthcare professional.
About Salubris
Shenzhen Salubris Pharmaceuticals Co., Ltd. (Stock Code: 002294), founded in 1998 and listed on the Shenzhen Stock Exchange in 2009, is an innovation-driven pharmaceutical company headquartered in China with a global outlook. The company integrates R&D, production, and sales and is committed to addressing unmet medical needs in chronic diseases such as cardiovascular and cerebrovascular diseases, diabetes, cancer, osteoporosis, and chronic kidney disease.
Salubris possesses full-spectrum capabilities in innovative drug discovery and development, supported by five global R&D centers. Its innovation platforms focus on small-molecule chemical drugs, biological drugs, siRNA-based therapeutics, gene-editing therapies, and medical devices, aiming to deliver clinically meaningful innovative products.
With a mission to enhance medication accessibility, Salubris’ products are available in multiple countries and regions across Europe, Asia, Africa, North America, and South America, benefiting patients worldwide.
