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505(b)(2) New Drug for Schizophrenia Receives FDA Approval to Proceed with Phase I Clinical Trial
  • 2025-10-06

Anxo’s 505(b)(2) New Drug for Schizophrenia Receives FDA Approval to Proceed with Phase I Clinical Trial

The Company’s 505(b)(2) new drug for the treatment of schizophrenia, AX251, has received approval from the U.S. Food and Drug Administration (FDA) to proceed with a Phase I clinical trial. AX251 is a long-acting nanocrystal new drug developed using the Company’s proprietary long-acting, sustained-release platform, designed to improve patient medication compliance, and represents a new dosage-form drug strategy for entering the global market.