Anxo Pharmaceutical's Schizophrenia Drug Candidate Completes World's First Patient Dosing, Targeting Multi-Billion-Dollar Long-Acting Injectable Market

Anxo Pharmaceutical Co. (“Anxo,” stock code: 6677), a specialized drug delivery technology developer, today (the 14th) announced a major milestone: AX251, its schizophrenia drug candidate that has received FDA clearance for a Phase 1 clinical trial, has completed dosing of the world's first patient, formally launching an international Phase 1 human clinical trial. This marks the moment Anxo's proprietary Nano-Crystal Injectable Platform (NanoCIP) technology officially moves from the laboratory into clinical validation, securing a critical first-mover advantage for the company in the global race for long-acting antipsychotic drugs.

According to Anxo, this represents a strategy of “capturing the market with a single injection.” Grand View Research projects the global schizophrenia drug market will reach US$11.2 billion by 2030, growing at a compound annual growth rate of 5.6%, and AX251 is squarely targeting this vast opportunity.

This trial is a multicenter, open-label, dose-escalation and dose-expansion Phase 1 clinical study that will evaluate the pharmacokinetics, safety, and tolerability of a single injection of AX251 in patients with schizophrenia — an important step on AX251's path toward market approval.

AX251 is not a new molecular entity. Rather, Anxo's proprietary NanoCIP platform achieves a breakthrough reformulation of an oral drug already marketed worldwide, micronizing it down to nanometer- and submicron-scale particles. Administered via subcutaneous or intramuscular injection, it provides stable, sustained release for more than four weeks, transforming daily oral dosing into a single monthly injection. This means patients no longer need to struggle with the risk of forgetting to take their medication, while bioavailability is significantly improved, blood concentration levels are more stable, and the risk of side effects is correspondingly reduced.

Anxo General Manager Lin-Chiuan Yan noted that the technical barriers to the NanoCIP platform are extremely high, with only a handful of drugs worldwide using similar technology having reached the market — and these are heavily concentrated in the psychiatric field. The small-molecule chemical compound used in AX251 is currently only marketed in oral form, and the original oral brand-name drug generates global annual sales of US$4.571 billion. While international competitors have already begun developing long-acting injectable versions, Anxo — backed by a comprehensive global patent portfolio, exclusive platform advantages, and outstanding manufacturing scalability — holds strong potential to become a next-generation, representative antipsychotic medication.