paliperidone palmitate ER (LY03010) / Luye Group - LARVOL DELTA

Luye Pharma Announces U.S. Launch of ERZOFRI (paliperidone palmitate) Extended-Release Injectable Suspension for the Treatment of Schizophrenia and Schizoaffective Disorder (The Manila Times) - "Luye Pharma Group...announced that ERZOFRI (paliperidone palmitate) extended-release injectable suspension is now available for commercial sale in the U.S. for the treatment of adults with schizophrenia and as a monotherapy or adjunct therapy for the treatment of adults with schizoaffective disorder....ERZOFRI, administered once a month, delivers the active ingredient, paliperidone, through a long-acting, extended-release delivery system. It simplifies treatment by enabling single-dose initiation due to its unique 351 mg initiation dose. The currently prescribed monthly paliperidone palmitate long-acting injectable (LAI) requires two initiation doses, on Day 1 and Day 8. "

Launch US • CNS Disorders • Schizophrenia

Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder (clinicaltrials.gov) - P1 | N=89 | Completed | Sponsor: Luye Pharma Group Ltd. | Recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

Relative Bioavailability of LY03010 Compared to Listed Drug (clinicaltrials.gov) - P1 | N=281 | Completed | Sponsor: Luye Pharma Group Ltd. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Luye Pharma Group Ltd.

New P1 trial • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

FDA Approves First Six-Month LAI Antipsychotic - "'The longer duration adds a convenience factor, so it will benefit remote individuals, those with limited health care access, and people who do not like injections,' he told Psychiatric News. 'But while the clinical data show the six-month injection is not inferior to the three-month one, there is no indication that it is any better.'"

Media quote • Regulatory • Schizophrenia

Relative Bioavailability of LY03010 Compared to Listed Drug (clinicaltrials.gov) - P1; N=281; Active, not recruiting; Sponsor: Luye Pharma Group Ltd.; Recruiting ➔ Active, not recruiting; Trial completion date: Jan 2022 ➔ Apr 2022

Clinical • Enrollment closed • Trial completion date • CNS Disorders • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

Relative Bioavailability of LY03010 Compared to Listed Drug (clinicaltrials.gov) - P1; N=280; Recruiting; Sponsor: Luye Pharma Group Ltd.

Clinical • New P1 trial • CNS Disorders • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

Luye Pharma’s Innovative Formulation LY03010 Begins Pivotal Study in the U.S. (Luye Press Release) - "Luye Pharma announced today that a pivotal study has started in the U.S. for the company's in-house developed innovative formulation, Paliperidone Palmitate extended-release injectable suspension (LY03010)....At the pre-IND meeting, the U.S. Food and Drug Administration (FDA) confirmed that demonstration of bioequivalence at steady state after multiple doses would be acceptable to support the 505(b)(2) New Drug Application (NDA) submission for LY03010. After the completion of two clinical studies in U.S., the clinical protocol relating to the pivotal study for LY03010 was submitted to the FDA, following which the FDA completed its review and agreed to the proposal."

Trial status • CNS Disorders • Schizophrenia

Evaluate the PK of LY03010 Process 1 and Process 2 Drug Product vs INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients (clinicaltrials.gov) - P1; N=36; Completed; Sponsor: Luye Pharma Group Ltd.

Clinical • New P1 trial • CNS Disorders • Psychiatry • Schizophrenia

A Study to Determine Pharmacokinetic Characteristics of LY03010 Versus INVEGA SUSTENNA® in Schizophrenia Patients (clinicaltrials.gov) - P1; N=48; Completed; Sponsor: Luye Pharma Group Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion

A Study to Determine Pharmacokinetic Characteristics of LY03010 Versus INVEGA SUSTENNA® in Schizophrenia Patients (clinicaltrials.gov) - P1; N=48; Active, not recruiting; Sponsor: Luye Pharma Group Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed