Bayer's sGC Agonist BAY 3283142 Granted IND Approval in China for Chronic Kidney Disease

Intelligent Finance APP learned that recently, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration disclosed that Bayer's (BAYRY.US) Class 1 new drug, BAY 3283142 Hydrochloride Tablets, has obtained tacit approval for clinical trials in China and is proposed for development to treat chronic kidney disease. According to publicly available information, this is a soluble guanylate cyclase (sGC) agonist, and Bayer has previously completed three Phase 1 studies on this drug.

It is understood that sGC is an important enzyme in the nitric oxide (NO) signaling pathway, and is crucial for the function of blood vessels and the heart. When NO binds to sGC, the enzyme catalyzes the synthesis of cyclic guanosine monophosphate (cGMP) within the cell. cGMP, a second messenger, plays a role in regulating vascular tone, cardiac contractility, and cardiac remodeling, and is also considered beneficial for chronic kidney disease.

According to the ClinicalTrials website, Bayer has initiated three Phase 1 clinical studies on BAY 3283142 to evaluate the product's safety, pharmacokinetics, and its impact on participants with reduced renal function and mild to moderate hypertension.

Previously, the sGC stimulator vericiguat, jointly developed by Bayer and Merck (MSD), was approved for marketing in the United States in 2021. According to an earlier FDA press release, this is also the first sGC stimulator for the treatment of patients with worsening chronic heart failure.

In addition, according to official information from Bayer, the company has an sGC stimulator, runcaciguat (BAY 1101042), in its pipeline, which is currently in Phase 2 clinical trials for the treatment of non-proliferative diabetic retinopathy (NPDR).