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A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Characteristics of Multiple Doses of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia

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Trial Profile

A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Characteristics of Multiple Doses of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 10 Aug 2026

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At a glance

  • Drugs LY 03015 (Primary)
  • Indications Tardive dyskinesia
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Luye Pharma Group

Most Recent Events

  • 05 Aug 2026 According to a Luye Pharma group media release, based on the results from this phase II clinical trial in China, company plans to adopt a simplified dosing regimen for patients enrolled in its planned efficacy clinical trial in the U.S. Compared with the dose-titration regimens commonly adopted in current clinical practice, LY03015 is expected to demonstrate a differentiated market value proposition in terms of efficacy, onset of action and dosing convenience.
  • 16 Jun 2026 Status changed from recruiting to completed, as per Luye Pharma Group media release.
  • 16 Jun 2026 Primary endpoint has been met. (Change in Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score)

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