Dimdazenil Capsules Approved for Marketing by China NPMA for Short Term Treatment of Insomnia Disorders

Nov, 2023. Class 1 innovative drug Dimdazenil Capsules from Zhejiang Jingxin Pharmaceutical Co., Ltd is approved for marketing by China NPMA for short term treatment of insomnia disorders.

Dimdazenil is a benzodiazepine drug that is a partial positive allosteric modulator of gamma-aminobutyric acid type A (GABAA) receptors. It promotes sleep by partially activating GABAA receptors. The launch of this drug provides new treatment options for patients with insomnia disorders.

Insomnia disorder is a common clinical problem characterized by difficulty falling or staying asleep, or waking up too early. Insomnia disorder brings problem to estimated 10%–20% of the general population with a higher incidence in women, the elderly, and those with comorbid medical and psychiatric conditions. Dimdazenil is a novel partial positive allosteric modulator of the GABAA receptor with high affinity and moderate efficacy. As a result, Dimdazenil offers an improved safety profile compared to full agonists. Dimdazenil exhibited a favorable safety profile and was well-tolerated, without altering sleep architecture or impairing next-day vigilance and cognition. These findings demonstrate Dimdazenil’s promising potential as an insomnia therapy, with rapid sleep promotion, sustained efficacy over time, and an absence of next-day hangover effects.^[2]https://academic.oup.com/sleep/advance-article/doi/10.1093/sleep/zsad271/7326687

Dimdazenil (EVT201) was first developed by the German company Evotec. Jingxin Pharmaceutical cooperate with Evotec and obtained the exclusive patent license and development rights of the drug in China, and was responsible for the development, registration and sales of preparations of the compound in China. Since then, Jingxin Pharmaceutical has promoted the clinical development of EVT201 in China. Randomized, double-blind, placebo-controlled, multi-center phase III study of EVT201 (JX202001-EVT201-III) in the treatment of insomnia disorder showed that it achieved the primary and secondary endpoints. The research results were significantly effective. Both doses improved sleep quality, with no difference in self-rated morning sleepiness compared to placebo, and was well tolerated, with no serious or unexpected adverse events reported.

About Jingxin Pharmaceutical

Founded in 1990, Zhejiang Jingxin Pharmaceutical Co., Ltd. is a listed pharmaceutical company integrating R&D, production and sales. Adhering to the business guideline of “strengthening the main business of pharmaceuticals and developing medical devices”, we adhere to the core values of “pragmatic, innovative, inclusive and win-win”. Jingxin aims to fulfill our duty of “careful protection of health” and to take the lead in psycho-neural and cardiovascular fields.^[3]https://www.jingxinpharm.com/en/index.php/about.html