Anxo's New Schizophrenia Drug Submitted for U.S. Phase I Clinical Trial Application

Anxo Pharmaceutical Co. (“Anxo”) has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for AX251, a novel drug for the treatment of schizophrenia. Classified as a 505(b)(2) new drug, AX251 is a next-generation long-acting, sustained-release injectable formulation developed by reformulating an already-marketed oral drug using Anxo’s proprietary nanocrystal injectable platform (NanoCIP). The new formulation significantly improves bioavailability while reducing side effects.

NanoCIP applies nanotechnology to drug delivery systems, reducing drug particle size to the nanometer and sub-micron range. When injected subcutaneously or intramuscularly, this enables long-acting drug release, sustaining blood drug concentrations and enhancing bioavailability. However, the platform technology involves parameter optimization and aseptic process control in nano-grinding processes, as well as complex variables affecting drug release rates, resulting in high barriers to entry. Currently, there are not many drugs available on the market globally, and most of them are antipsychotic drugs.

AX251, independently developed by Anxo, more precisely targets dopamine D3 receptors in the brain’s central nervous system, alleviating schizophrenia symptoms such as delusions, hallucinations, disordered thinking, and blunted emotional expression, while avoiding side effects commonly associated with other antipsychotic drugs, such as extrapyramidal symptoms, psychomotor sedation, and cognitive dulling. In addition, AX251 provides sustained drug release for at least four weeks, maintaining blood drug concentrations and enhancing bioavailability. Compared with oral medications requiring daily dosing, AX251 offers improved patient compliance, reduced dosing frequency, and lower side effects, and its manufacturing process is scalable — giving it the potential to become a next-generation long-acting antipsychotic drug.

AX251 is protected by a comprehensive global patent portfolio. The Phase I clinical trial application submitted to the FDA will evaluate the safety, pharmacology, and tolerability of AX251. If all goes smoothly, patient enrollment for the clinical trial is expected to begin in the first quarter of next year.