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A Study to Evaluate the PK Profiles of LY03010 and Relative Bioavailability at Steady-state of LY03010 Versus INVEGA SUSTENNA in Schizophrenia Patients

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A Study to Evaluate the PK Profiles of LY03010 and Relative Bioavailability at Steady-state of LY03010 Versus INVEGA SUSTENNA in Schizophrenia Patients

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 29 Jul 2024

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At a glance

  • Drugs Paliperidone (Primary) ; Paliperidone
  • Indications Schizoaffective disorder; Schizophrenia
  • Focus Pharmacokinetics; Registrational
  • Sponsors Luye Pharma Group

    • Most Recent Events

    • 28 Jul 2024 According to a Luye Pharma Group media release, U.S. Food and Drug Administration (FDA) has approved the companys ERZOFRI (paliperidone palmitate) extended-release injectable suspension, for treating schizophrenia in adults and for treating schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.
    • 27 Jun 2024 According to a Luye Pharma Group media release, as per Prescription Drug User Fee Act (PDUFA), the target date for the FDA to make a decision on the NDA of LY03010 is 26 July 2024.
    • 02 Apr 2024 According to a Luye Pharma Group media release, the FDA also started to review the New Drug Application (NDA) of LY03010

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