Teva shares Phase 3 data on once-monthly schizophrenia injection

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) presented post hoc data from the Phase 3 SOLARIS trial for its investigational drug TEV-'749, a once-monthly subcutaneous long-acting injectable formulation of olanzapine for the treatment of schizophrenia in adults. The findings were presented at Psych Congress in New Orleans on Sept. 18, 2026.

In a post hoc analysis of the open-label period of the SOLARIS trial, 231 of 411 participants (56%) achieved stabilization across three dose groups of 318 mg, 425 mg, and 531 mg. Among those who achieved stabilization, only 10 (4%) experienced relapse. Of 183 participants treated for six or more months, 39 (21%) met criteria for remission, defined as maintaining a Positive and Negative Syndrome Scale score of 3 or lower for at least six consecutive months across eight specific remission items.

Separate analyses simulating switching scenarios found that initiating TEV-'749 one day after the last dose of oral or short-acting intramuscular olanzapine produced olanzapine exposures within established oral therapeutic ranges. An additional analysis found that the metabolic profile of TEV-'749 was consistent with daily oral olanzapine formulations, with no clear dose-dependent pattern observed.

"These findings further validate the long-term clinical profile of TEV-'749 and its potential to be a once-monthly subcutaneous injectable olanzapine treatment that can help support stabilization for people living with schizophrenia," said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva.

TEV-'749 is not currently approved by any regulatory authority. The FDA is expected to issue a PDUFA decision on TEV-'749 in Q4 2026. The European Medicines Agency accepted a Marketing Authorization Application for the drug in May 2026. TEV-'749 uses SteadyTeq, a copolymer technology licensed from Medincell that provides sustained release of olanzapine.

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