Anxo Pharmaceutical’s AX251 Completes World’s First Patient Dosing
Anxo Pharmaceutical (TW: 6677), a developer of drug delivery technologies, announced in a press release on the 14th of September that AX251, its 505(b)(2) schizophrenia drug candidate that received FDA clearance for a Phase I clinical trial, has completed dosing of the world’s first patient. The milestone formally launches an international Phase I trial and marks the transition of Anxo’s proprietary Nano-Crystal Injectable Platform (NanoCIP) from laboratory development to clinical validation.
The multicenter, open-label, dose-escalation and dose-expansion Phase I study will evaluate the pharmacokinetics, safety, and tolerability of a single AX251 injection in patients with schizophrenia, representing an important step toward potential market approval.
AX251 is not a new molecular entity. Instead, NanoCIP reformulates an oral drug already marketed worldwide by reducing the active ingredient to nano- and submicron-sized particles. Delivered by subcutaneous or intramuscular injection, AX251 is designed to provide stable, sustained release for more than four weeks, potentially replacing daily oral dosing with a once-monthly injection. The approach may improve adherence, bioavailability, and stability of blood drug concentrations while reducing the risk of side effects.
Anxo Pharmaceutical referenced Grand View Research that the global schizophrenia drug market is projected to reach US$11.2 billion by 2030, representing a 5.6% CAGR. Anxo General Manager Lin-Chiuan Yan said NanoCIP faces high technical barriers, with only a limited number of drugs using similar technology having reached the market, particularly in psychiatry.
The small-molecule compound used in AX251 is currently marketed only in oral form, with the original branded drug generating approximately US$4.571 billion in annual global sales. While international competitors are developing long-acting injectable versions, Anxo said its global patent portfolio, proprietary platform, and scalable manufacturing capabilities position AX251 as a potential next-generation long-acting antipsychotic.