By: IPP Bureau
Last updated : September 15, 2025 11:48 am
This approval follows the CDE’s clearance in July of this year for Phase 2/3 clinical studies of CB03-154 in amyotrophic lateral sclerosis
Shanghai Zhimeng Biopharma (Zhimeng Biopharma) announced that its novel next-generation KCNQ2/3 potassium channel opener, CB03-154, has received clinical trial approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to initiate a Phase 2 clinical study for refractory epilepsy.
This approval follows the CDE’s clearance in July of this year for Phase 2/3 clinical studies of CB03-154 in amyotrophic lateral sclerosis (ALS).
The upcoming trial will be a randomized, double-blind, placebo-controlled, multinational, multicenter study designed to evaluate the efficacy, safety, and tolerability of CB03-154 as an adjunctive therapy in adult patients between the ages of 18 and 70 with focal epilepsy.
Epilepsy is one of the most common neurological disorders worldwide, affecting approximately 90 million people globally, including about 9 million in China. Despite the availability of existing therapies, nearly 30 percent of patients suffer from refractory epilepsy that cannot be managed by monotherapy.
The disease is closely linked to dysfunction in ion channels and synaptic transmission, leading to an imbalance between neuronal excitation and inhibition. Potassium (K+) channels, which play a critical role in regulating neuronal excitability and action potentials, are particularly associated with the development of epilepsy.
CB03-154 is a next-generation KCNQ2/3 potassium channel opener that has demonstrated strong chemical and metabolic stability, favorable pharmacokinetics, in vitro and in vivo anti-epileptic activity, and a positive safety profile. With its more specific ion channel selectivity, the drug has the potential to overcome safety limitations observed with earlier-generation therapies. Clinical studies of CB03-154 for epilepsy are also ongoing in Australia.
Beyond epilepsy, KCNQ2/3 potassium channel openers are being studied for their potential in treating major depressive disorder (MDD), ALS, and neuropathic pain. CB03-154 has previously been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of ALS.