Livzon's NS-041 tablet gets green light for depression trials

Livzon Pharmaceutical Group Inc. announced its wholly-owned subsidiary, Livzon Pharmaceutical Factory, has received clinical trial approval from the National Medical Products Administration for NS-041 Tablet to treat depression. This Class 1 chemical drug is a novel KCNQ2/3 agonist.

The NS-041 Tablet is unique in China as the only KCNQ2/3 agonist approved for clinical studies in both epilepsy and depression. It had previously received approval on December 27, 2023, for epilepsy clinical trials, which are currently in Phase II. Preclinical studies for depression demonstrated favorable antidepressant effects with high target selectivity and no ocular toxicity risk. Livzon Pharmaceutical Factory obtained exclusive rights to the drug in Greater China through a licensing agreement with NeuShen Therapeutics (Shanghai) Co., Ltd. in 2024.

As of the announcement date, Livzon has incurred approximately RMB 58.5394 million in direct research and development expenses for NS-041 Tablet. The company notes that no new generation of KCNQ2/3 targeting drugs has been marketed in China. However, the path from clinical trials to market launch is lengthy and subject to uncertainties and inherent risks.