AstraZeneca's Class 1 New Drug AZD5462 Granted IND Approval in China for Heart Failure Treatment

Intelligent Finance APP learned that today (November 29), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration showed that AstraZeneca's (AZN.US) Class 1 new drug, AZD5462 tablets, has received clinical trial implied permission, intended for the development of treatment for heart failure. According to information on AstraZeneca's official website, this is a small molecule drug that acts as an RXFP1 agonist and is currently in Phase 2 clinical research internationally. A search on the CDE’s official website reveals that this is the first time the drug has been approved for clinical trials in China.

Screenshot source: CDE official website

It is reported that RXFP1 is a relaxin receptor, which is widely expressed in many organs and tissues, including the heart, kidneys, and blood vessels. Relaxin is an endogenous heterodimeric insulin-like peptide that has beneficial physiological effects in the cardiovascular system and demonstrates good safety.

According to the ClinicalTrials website, AstraZeneca is conducting a Phase 2b clinical trial of AZD5462 to evaluate its impact on cardiac function in patients with chronic heart failure (HF). The study plans to enroll 360 participants internationally and is expected to be completed by November 2025. The recent approval of AZD5462 for clinical trials in China marks its entry into the clinical development phase in the country.