A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label, Long-Term Safety Phase to Evaluate the Efficacy and Safety of TV-44749 in Adults With Schizophrenia

Summary

The primary objective of this study is to evaluate the efficacy of TV-44749 in adult participants with schizophrenia. A key secondary objective is to further evaluate the efficacy of TV-44749 based on additional parameters in adult participants with schizophrenia. A secondary objective is to evaluate the safety and tolerability of TV-44749 in adult participants with schizophrenia Another secondary objective of this study is to evaluate the efficacy of TV-44749 from baseline to endpoint in Period 1 in adult participants with schizophrenia. Total study duration is up to 61 weeks, and treatment duration is up to 56 weeks, with weekly visits during the first 8 weeks and then monthly in-clinic visits with weekly calls during the remainder of the treatment period.

Timeline

Start

2023-01-24

Primary completion

2024-03-19

Completion

2025-01-27

Publications

• Cherniakov I, Wagner AM, Eshet R, Tiver R, Bibi D, Perlstein I, Kalmanczhelyi A, Sharon N, Cohen G, Ferderber K, Roberts J, Elgart A, Gutman D, Rabinovich-Guilatt L. Safety, Tolerability, and Pharmacokinetics of Subcutaneous Extended-Release Injectable Olanzapine in Patients with Schizophrenia and Schizoaffective Disorder. Clin Drug Investig. 2026 Mar;46(3):307-320. doi: 10.1007/s40261-025-01507-x. Epub 2026 Feb 3.
• Perlstein I, Cherniakov I, Elgart A, Gomeni R, Gutman D, Merenlender Wagner A, Singh R. Population Pharmacokinetic Model-Based Dose Selection of Extended-Release Injectable Olanzapine (TV-44749) for Subcutaneous Use in Phase 3 Clinical Trial in Adults with Schizophrenia. J Clin Pharmacol. 2026 Jan;66(1):e70144. doi: 10.1002/jcph.70144.

Drugs

Indications