SYSTEMATIC REVIEW article
Front. Psychiatry
Sec. Psychopharmacology
Volume 16 - 2025 | doi: 10.3389/fpsyt.2025.1599038
Exploration of current situation of psychotropic drugs research and development in China based on drug clinical trials
Provisionally accepted
- Department of Pharmacy, Guangyuan Central Hospital, Guangyuan, China
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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 chinadrugtrials.org.cn, 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 (P < 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.
Keywords: psychiatric disorders, Pharmacotherapy, clinical trials, innovative drugs, Drug optimization, Trial design
Received: 17 Apr 2025; Accepted: 25 Jun 2025.
Copyright: © 2025 Xu, Zhao, Yang, Zheng and Tang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Chen Xu, Department of Pharmacy, Guangyuan Central Hospital, Guangyuan, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.