AstraZeneca's (AZN.US) first-in-class drug approved for clinical trials in China, aiming to develop for heart failure
1min read Today (Nov. 29), China National Medical Products Administration's (NMPA) Center for Drug Evaluation (CDE) website has recently announced that AZN.US's AZD5462 tablets, a Class 1 new drug, has been granted a clinical trial implicit approval, intended to develop for the treatment of heart failure. According to AstraZeneca's website, it is a small molecule drug that activates RXFP1, which is currently in Phase 2 clinical trials worldwide. Through the CDE's website, it can be known that this is the first time the drug has been approved for clinical trials in China.
Source: CDE's website
It is known that RXFP1 is a relaxin receptor widely expressed in many organs and tissues, including the heart, kidneys, and blood vessels. Relaxin is an endogenous heterodimeric insulin-like peptide with beneficial physiological effects in the cardiovascular system and good safety.
According to ClinicalTrials.gov, AstraZeneca is conducting a Phase 2b clinical study to evaluate the effect of AZD5462 on heart function in patients with chronic heart failure (HF). The study is planned to enroll 360 participants worldwide and is expected to be completed in November 2025. The approval of AZD5462 for clinical trials in China means that it will enter the clinical development stage in China.
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