Recently, Salubris announced that the clinical trial application for a new indication of its self-developed innovative small molecule drug, SAL0140 tablets (Project Code: SAL0140), has been accepted by the National Medical Products Administration (NMPA) [1].
The submitted application is for a clinical trial of SAL0140 intended for the treatment of Primary Aldosteronism (PA) [1].
SAL0140 is an aldosterone synthase inhibitor with independent intellectual property rights. Its potential indications include uncontrolled hypertension (including resistant hypertension), chronic kidney disease (CKD), and Primary Aldosteronism, among others. Currently, SAL0140 (for uncontrolled hypertension) is poised to commence Phase II clinical trials.
Aldosterone is the most important mineralocorticoid in the human body to help maintain fluid and electrolyte balance, and directly be involved in target organ damage in various cardiovascular and renal diseases.
Primary Aldosteronism (PA) refers to the autonomous secretion of aldosterone by the adrenal cortex, leading to sodium retention, potassium excretion, increased blood volume, and suppressed renin-angiotensin system activity. Its clinical manifestations primarily include hypertension and hypokalemia. Studies have found that excess aldosterone is a significant risk factor for myocardial hypertrophy, heart failure, and renal impairment. Compared to patients with essential hypertension, those with PA experience more severe damage to target organs such as the heart and kidneys [2].
PA occurs in over 4.0% of newly diagnosed hypertensive patients, and its prevalence increases with rising blood pressure levels, reaching approximately 17%–23% among patients with resistant hypertension [2]. Aldosterone synthase inhibitors hold development potential, as they are expected to directly suppress aldosterone synthesis, reduce aldosterone levels in PA patients, and subsequently lower blood pressure and mitigate organ damage.
If successfully developed and approved for marketing, SAL0140 is expected to provide targeted new treatment options for more specific subgroups of hypertensive patients and those with Chronic Kidney Disease (CKD), address unmet clinical needs and further enrich the company's innovative product pipeline in the cardio-renal-metabolic chronic disease areas.
References:
[1] Shenzhen Salubris Pharmaceuticals Co., Ltd. Announcement on the Acceptance of the Clinical Trial Application for SAL0140.
[2] Expert Consensus on the Diagnosis and Treatment of Primary Aldosteronism (2024 Edition).
Disclaimer:
1. This material is intended to provide knowledge in the field of disease, enhance disease awareness, and is not for promotional purposes.
2. The information contained herein is for reference only. Please follow the advice or guidance of physicians or other healthcare professionals.
| About Salubris
Shenzhen Salubris Pharmaceuticals Co., Ltd., founded in 1998, is an innovation-driven pharmaceutical listed company (Stock Code: 002294) with integrated R&D, production, and marketing operations, rooted in China and serving the global market. With the mission of "providing exceptional pharmaceutical products for human health," Salubris has deepened its expertise in chronic disease treatment with a focus on cardiovascular and cerebrovascular conditions. The company has successfully commercialized alisartan monotherapy, combination drugs, and co-crystal formulations to address diverse complex hypertension challenges, establishing a unique family of first-in-class antihypertensive therapies centered on alisartan.
Salubris has established five innovative drug R&D centers and three medical device R&D bases globally, creating innovation platforms focused on small molecule drugs, biological drugs, siRNA therapeutics, gene-editing therapies, and medical devices. The company is committed to developing innovative products that address unmet clinical needs, with the goal of enhancing people's quality of life and extending healthy lifespan.
