Olanzapine LAI (44749) - (SOLARIS)

September 18, 2026: Teva Pharmaceuticals (NYSE/TASE: TEVA) reported new post hoc Phase 3 SOLARIS data for investigational once-monthly subcutaneous olanzapine LAI TEV-’749 in adults with schizophrenia at Psych Congress 2026 (Sept. 15–19, New Orleans), ahead of an expected FDA PDUFA decision in Q4 2026.

In the open-label long-term treatment period, 231 of 411 participants (56%) achieved stabilization; by dose group, stabilization rates were 61%, 54%, and 54% for 318 mg, 425 mg, and 531 mg. Among the 231 stabilized participants, 10 (4%) relapsed. Among 183 participants treated for at least 6 months, 39 (21%) met remission criteria based on sustained PANSS item scores.

Separate pharmacokinetic switching analyses indicated that starting TEV-’749 one day after the last dose of oral or short-acting intramuscular olanzapine produced olanzapine exposures within established oral therapeutic ranges, supporting direct-switch strategies. A metabolic analysis found a profile consistent with daily oral olanzapine, with no clear dose-dependent pattern.

TEV-’749 remains unapproved. The European Medicines Agency accepted the MAA in May 2026.