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This phase II trial evaluates safety and tolerability of extended-release olanzapine, indicating its potential for long-term management in schizophrenia.
TV-44749 administration resulted in a sustained release profile and comparable exposure to daily therapeutic doses of oral olanzapine over a monthly dosing interval. The TV-44749 systemic safety profile was consistent with approved oral olanzapine. The local tolerability was acceptable, and there were no PDSS events. These results contributed to the dose selection of TV-44749 in a phase III study evaluating its efficacy and safety in adults with schizophrenia (SOLARIS; NCT05693935).
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Cherniakov et al. (2026) studied this question.
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