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To analyze the current status and development trends of registered clinical trials of inhalation preparations in China, and to provide references for drug development and clinical evaluation.
Clinical trials of inhalation preparations registered on the NMPA Platform for Drug Clinical Trial Registration and Information Publicity from its inception to December 31, 2025 were retrieved. Descriptive statistical analysis was conducted on the basic information, design types, drug characteristics, and indications of the trials.
A total of 445 registered clinical trials of inhalation preparations were included, which had entered a rapid development phase in the past five years. The trials were predominantly domestic (94.61%) and bioequivalence (BE) studies (48.31%). The most common dosage forms were liquid inhalation formulations (44.04%) and dry powder inhalations (35.51%). Research and development were highly concentrated on asthma and chronic obstructive pulmonary disease, with inhaled corticosteroids and their combinations being the main directions. In contrast, trials involving childer and adolescents accounted for only 4.94%, and explorations in areas such as pulmonary fibrosis and pulmonary infections remained relatively limited. Sponsors and research resources were primarily concentrated in the more developed pharmaceutical regions such as Beijing, Shanghai, and Jiangsu.
The development of inhalation preparations in China has entered a phase of rapid growth, characterized by a dominance of generic drugs, a high concentration of therapeutic areas, and differentiated development of dosage forms. Future efforts should focus on unmet clinical needs and innovative research and development of high-technical-barrier dosage forms to promote high-quality development in this field.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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