Sichuan Guangda Pharmaceutical Manufacturing Co., Ltd., a subsidiary of Livzon Pharmaceutical Group Inc. (Livzon Pharma), has received a Drug Clinical Trial Approval Notice (No. 2026LP03296) from China’s National Medical Products Administration (NMPA) to initiate clinical studies of Tiange Dingxuan Granules for the treatment of vestibular migraine.
Tiange Dingxuan Granules, formulated with traditional Chinese medicinal ingredients such as Gastrodia elata and Pueraria lobata, are classified as a Class 1.1 innovative traditional Chinese medicine. Each 7g sachet contains the equivalent of 20.79 g of prepared herbs (2.97 g per gram).
The product targets vestibular migraine—a condition characterized by recurrent vertigo and migraine-related symptoms for which no drug has yet been approved in China or internationally. Current management relies on empirical use of migraine therapies, underscoring a substantial unmet medical need.
Pre-clinical studies conducted under Good Laboratory Practice demonstrated that the granules improved pain sensitivity, balance, and motor coordination in animal migraine models, while significantly reducing biomarkers such as nitric oxide and calcitonin gene-related peptide. Toxicology work indicated a single-dose maximum tolerated exposure of approximately 293–327 times the proposed clinical daily dose, and a 13-week no-observable-adverse-effect level of 14.1 times the intended human dose.
Livzon Pharma has invested approximately RMB 7.34 million in the development of Tiange Dingxuan Granules to date. The company holds global rights to the asset, which was co-developed with Dongfang Hospital, Beijing University of Chinese Medicine.
The approval allows the commencement of clinical trials; commercialisation will require successful trial outcomes and subsequent NMPA marketing authorisation, processes that remain subject to standard development risks and regulatory review.
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