rotigotine microspheres (LY03009) / Luye Group - LARVOL DELTA

Studying spatial drug distribution in golf ball-shaped microspheres to understand drug release. (PubMed, J Control Release) - "Finally, two linear Level A in vitro-in vivo correlations were established and validated, indicating that the in vitro release testing could be a meaningful predictor for the in vivo performance of GSRM. Our work demonstrates the importance of studying drug distribution in complex microspheres to understand drug release."

Journal

Luye Pharma (02186.HK): LY 03009, a new Parkinson's monthly injection microsphere drug, was approved for clinical trials in the United States [Google translation] (jrj.com) - "Luye Pharma...announced that its new drug LY03009 in the central nervous system has been approved by the U.S. Food and Drug Administration for clinical trials....In addition to the United States, the product is also undergoing Phase I clinical trials in Australia and has been approved for clinical trials in China."

IND • New trial • CNS Disorders • Parkinson's Disease • Restless Legs Syndrome

Luye Pharma’s Innovative Long-acting Microspheres Injection LY03009 Soon to Begin Clinical Trials in the U.S. (Luye Press Release) - "Luye Pharma Group today announced that it has submitted the Investigational New Drug (IND) application for its innovative microspheres injection LY03009 in the U.S., which will undergo Phase I clinical trials soon. LY03009 is for treating Parkinson’s disease (PD) and restless legs syndrome (RLS)....In addition to the U.S., the drug is also about to undergo clinical trials in China and is already undergoing Phase I clinical trials in Australia."

IND • CNS Disorders • Parkinson's Disease

Luye Pharma (02186): LY03009, a new drug in the central nervous system, was approved for clinical trials in China [Google translation] (jrj.com) - "Luye Pharmaceutical...issued an announcement that the group's new drug LY03009 in the central nervous field has been approved for clinical trials by the Drug Evaluation Center of the China National Medical Products Administration. LY03009 is used to treat Parkinson's disease....In addition to China, the product is also undergoing phase I clinical trials in Australia and plans to conduct clinical trials in the United States."

New trial • CNS Disorders • Parkinson's Disease

to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers (clinicaltrials.gov) - P1; N=40; Enrolling by invitation; Sponsor: Luye Pharma Group Ltd.; Not yet recruiting ➔ Enrolling by invitation; Initiation date: Oct 2020 ➔ Feb 2021

Clinical • Enrollment open • Trial initiation date • CNS Disorders • Movement Disorders • Parkinson's Disease

Luye Pharma’s Monthly Long-Acting Microspheres Injection LY03009 Starts Phase I Clinical Study in Australia (Luye Press Release) - "Luye Pharma Group has announced the beginning of the phase I clinical study of the company’s self-developed microsphere injection LY03009 in Australia. LY03009 is a monthly injection indicated for Parkinson’s disease (PD) and moderate to severe Restless legs syndrome (RLS)."

New P1 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Luye Pharma Group Ltd.

Clinical • New P1 trial • CNS Disorders • Movement Disorders • Parkinson's Disease