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Teva's Olanzapine LAI Shows Long-Term Schizophrenia Efficacy

Teva's Olanzapine LAI Shows Long-Term Schizophrenia Efficacy

Teva Pharmaceuticals has announced the presentation of new olanzapine LAI (TEV-'749) post hoc data from the pivotal SOLARIS phase 3 trial as well as analyses supporting treatment switch strategies. The SOLARIS data highlighted the acute and long-term durability, efficacy and safety of TEV-'749 as a once-monthly subcutaneous Long-Acting Injectable (LAI) formulation of olanzapine for the treatment of schizophrenia in adults. The findings were presented at Psych Congress, held September 15 to 19, 2026, in New Orleans, LA.

Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer, Teva, said, “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 stabilisation for people living with schizophrenia. For those currently taking daily oral olanzapine and may be interested in switching to an LAI, these data suggest that TEV-'749 can support long-term symptom control, helping to potentially fill an unmet need for this patient community.”

Olanzapine is the most widely prescribed atypical antipsychotic for schizophrenia as a daily oral treatment. However, daily options may make it difficult to sustain long-term symptom improvement due to challenges with adherence, increasing the risk for instability and relapse.

In a post hoc analysis of the long-term treatment open-label period of the phase 3 SOLARIS trial, more than half of all participants receiving TEV-'749 achieved stabilisation, more than one-fifth of long-term trial participants met criteria for remission (defined as maintaining a Positive and Negative Syndrome Scale [PANSS] item score of 3 or lower for at least 6 consecutive months across eight specific remission items), and few that had reached stabilisation relapsed.

Among 411 participants, 231 (56 percent [61 percent, 54 percent, and 54 percent with 318-, 425-, and 531-mg dose groups, respectively]) achieved stabilisation.

Among 231 participants who achieved stabilisation, only 10 (4 percent [6 percent, 1 percent, and 5 percent]) experienced relapse.

Among 183 participants who were treated with TEV-'749 for 6 or more months, 39 (21 percent [26 percent, 13 percent, and 26 percent]) achieved remission.

Christoph Correll, MD, Clinical Professor of Psychiatry, Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, said, “These TEV-'749 data are compelling because the vast majority of patients who start or respond well to olanzapine are treated with a daily oral pill of olanzapine. We know that Long-Acting Injectable treatment options may support stability and reduce risk of relapse, and TEV-'749 has the potential to offer many of these individuals the efficacy of olanzapine in a once-monthly formulation.

In separate analyses simulating potential switching scenarios in the inpatient, initiation of TEV-'749 one day after the last dose of oral or short-acting intramuscular olanzapine resulted in predictable olanzapine exposures that remained within established oral therapeutic ranges. The findings offer clinical insights into how healthcare providers may switch patients to TEV-'749 who are currently taking other olanzapine formulations.

Finally, an analysis of metabolic outcomes found that the metabolic profile of TEV-'749 was consistent with daily oral olanzapine formulations, with no clear dose-dependent pattern observed. These data add to the broader safety and tolerability findings from the SOLARIS program.

TEV-'749 is an investigational once-monthly subcutaneous LAI of the second-generation antipsychotic olanzapine. It is not approved by any regulatory authority for any use at this time.

More news about: clinical trials | Published by News Bureau | September - 22 - 2026

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