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.

ABSTRACT: TV-44749 is a long-acting subcutaneous (SC) injectable olanzapine based on a novel copolymer drug delivery technology ensuring controlled olanzapine release over the dosing interval. TV-44749's formulation and SC route of administration aim to eliminate the causes of post-injection delirium/sedation syndrome (PDSS) that may occur with the intramuscular LAI olanzapine formulation. The main objective of this analysis was to utilize a population pharmacokinetic (PPK) modeling and simulation approach to select TV-44749 doses for a Phase 3 clinical trial that are comparable to the oral olanzapine approved doses and achieve dopamine D2 receptor occupancy (D2RO) within the therapeutic range. The PPK model was developed using data from a Phase 1 study in healthy participants and patients with schi

SUBMITTER: Perlstein I 

PROVIDER: S-EPMC12775547 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature