Among 50 DKD drug trials in China (2013-2023), 48% were bioequivalence studies, most were chemical drugs (92%) with Irbesartan most tested (48%).
What is the landscape and characteristics of drug clinical trials for diabetic kidney disease in mainland China from 2013 to 2023?
Despite an increasing number of DKD trials in China, the landscape is dominated by bioequivalence studies of existing drugs like irbesartan, highlighting a significant gap in innovative drug research and development.
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With the increasing prevalence of diabetes, the incidence rate of diabetic kidney disease (DKD) has risen yearly in China. While traditional therapies like renin-angiotensin system blockers remain foundational, the treatment paradigm is rapidly evolving with the emergence of novel agents, including SGLT2 inhibitors, mineralocorticoid antagonists, endothelin receptor antagonists, and GLP-1 receptor agonists. This study aims to provide an overview of the changing landscape of drug clinical trials on DKD in mainland China from 2013 to 2023. Detailed information of drug trials for DKD registered on the National Medical Products Administration Registration and Information Disclosure Platform for Drug Clinical Studies was collected. A total of 50 trials for DKD were included. Bioequivalence trials accounted for the most significant proportion (48%), followed by phase II (22%), phase I (20%), and phase III (10%). Chemical drugs accounted for the largest proportion (92%), followed by traditional Chinese medicine/natural medicine (8%). There were 18 different drugs involved in the 50 trials with Irbesartan (n = 24, 48%) ranked first in the number of trials. The parallel-group design was primarily used (48%), followed by crossover design (46%). Randomization was used by almost all trials (92%). Of all trials, 44 (88%) were launched domestically, whereas only 6 (12%) were international multi-center trials. Drug trials showed an uneven geographical distribution. Despite the progress in DKD drug clinical trials in mainland China during recent years, innovative drug research and development still has a long way to go. These findings provide an evidence base for optimizing global-regional alignment in DKD innovation policy.
Yang et al. (Sun,) reported a other. Among 50 DKD drug trials in China (2013-2023), 48% were bioequivalence studies, most were chemical drugs (92%) with Irbesartan most tested (48%).