Exploration of current situation of psychotropic drugs research and development in China based on drug clinical trials.

OBJECTIVE

To understand the current status of research and development (R&D) of psychotropic drugs.

METHODS

Retrieved psychotropic drugs clinical trials (PDCTs) registered in China from 2019 to 2024 using the platform of , and systematically analyzed the data.

RESULTS

Included four perspectives: 1) for general information, we screened 1377 PDCTs, with phase bioequivalency (BE) accounting for the majority (78.5%), covering 411 pharmaceutical companies and 212 leading institutions, and the start-up time in 2024 was significantly shortened ( < 0.05); 2) for indications, 11 indications were involved, with the highest number of PDCTs for depression (30.9%); 3) for drugs, 222 drugs were involved, of which 52 were innovative drugs (33 with disclosed targets), and 13 were improved new drugs with six administration routes; 4) for trial design, four exploratory designs were retrieved, including population pharmacokinetics (9), pharmacogenomics (12), biomarker detection (3), and drug combination (3).

CONCLUSIONS

In recent years, clinical trials of psychotropic drugs in China have been developing. Innovative targets discovery, dosage forms/drug delivery systems optimization, and exploratory designs have the potential to break the current treatment dilemma. This study introduced the hotspots and potential development directions of psychotropic drugs R&D in China from the above aspects, providing new ideas for psychiatric treatment, drug development, and clinical trial methods.