Teva's Once-Monthly Subcutaneous Olanzapine LAI TEV-'749 Shows High Stabilization and Low Relapse in Phase 3 SOLARIS Post Hoc Data
核心洞察
Post hoc analysis of the Phase 3 SOLARIS open-label period found 231 of 411 participants (56%) receiving TEV-'749 (搜索) achieved clinical stabilization, with only 10 (4%) subsequently relapsing.
Among 183 participants treated with TEV-'749 (搜索) for six months or longer, 39 (21%) met criteria for remission based on sustained PANSS item scores.
Population pharmacokinetic simulations showed that starting TEV-'749 (搜索) one day after the last oral or short-acting intramuscular olanzapine dose kept exposures within established therapeutic ranges.
Teva Pharmaceuticals presented new post hoc analyses of the Phase 3 SOLARIS trial at Psych Congress 2026, held September 15 to 19 in New Orleans, showing that its investigational once-monthly subcutaneous long-acting injectable olanzapine, TEV-'749 (搜索), sustained symptom control in adults with schizophrenia (搜索). The data cover the open-label safety stage of the pivotal trial and include switching simulations intended to guide clinicians moving patients from existing olanzapine regimens.
Stabilization and Remission in the Open-Label Period
In the post hoc analysis of the long-term open-label treatment period, more than half of all participants receiving TEV-'749 (搜索) achieved stabilization, more than one-fifth of long-term participants met criteria for remission, and few who reached stabilization relapsed.
Among 411 participants, 231 (56%) achieved stabilization, with rates of 61%, 54% and 54% in the 318-mg, 425-mg and 531-mg dose groups, respectively. Of the 231 participants who achieved stabilization, only 10 (4%) experienced relapse, corresponding to 6%, 1% and 5% across the three dose groups. Among 183 participants treated with TEV-'749 (搜索) for six or more months, 39 (21%) achieved remission, defined as maintaining a Positive and Negative Syndrome Scale (PANSS) item score of 3 or lower for at least six consecutive months across eight specific remission items. Remission rates by dose group were 26%, 13% and 26%.
"These findings further validate the long-term clinical profile of TEV-'749 (搜索) and its potential to be a once-monthly subcutaneous injectable olanzapine treatment that can help support stabilization for people living with schizophrenia (搜索)," said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. "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 (搜索) as a daily oral treatment, but daily options may make it difficult to sustain long-term symptom improvement because of adherence challenges, which increase the risk of instability and relapse.
"These TEV-'749 (搜索) 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," said Christoph Correll, MD, Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY. "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."
Switch Strategies and Metabolic Profile
Separate analyses simulated potential switching scenarios in the inpatient setting. Initiating TEV-'749 (搜索) one day after the last dose of oral or short-acting intramuscular olanzapine produced predictable olanzapine exposures that remained within established oral therapeutic ranges, offering clinical insight into how healthcare providers may transition patients currently taking other olanzapine formulations.
An analysis of metabolic outcomes found that the metabolic profile of TEV-'749 (搜索) was consistent with daily oral olanzapine formulations, with no clear dose-dependent pattern observed. Teva said these data add to the broader safety and tolerability findings from the SOLARIS program.
Trial Design and Regulatory Status
SOLARIS was a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study evaluating the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use in patients aged 18 to 64 with schizophrenia (搜索). In period one, the first eight weeks, 675 patients were randomized 1:1:1:1 to once-monthly olanzapine LAI at low, medium or high dose or to placebo. In period two, the following 48 weeks, patients who completed period one on placebo were re-randomized equally to one of the three olanzapine LAI treatment groups, while those who completed period one on active treatment remained on their established dose strength. End-of-treatment and follow-up visits occurred 4 and 8 weeks after the last treatment dose, respectively.
The primary objective was to evaluate efficacy as measured by PANSS. A key secondary objective assessed additional parameters using CGI-S and PSP, and a secondary objective of period two was to evaluate safety and tolerability.
TEV-'749 (搜索) is an investigational once-monthly subcutaneous LAI of the second-generation antipsychotic olanzapine and is not approved by any regulatory authority for any use. It uses SteadyTeq (搜索), a copolymer technology proprietary to Medincell (搜索) that provides controlled, sustained release of olanzapine. A PDUFA decision from the FDA is expected in Q4 2026, and the European Medicines Agency accepted the Marketing Authorization Application in May 2026.
Disease Burden
Schizophrenia (搜索) is a chronic, progressive and severely debilitating mental disorder affecting how a person thinks, feels and acts, with symptoms that may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability. Approximately 1% of the world's population will develop schizophrenia in their lifetime, and 2.2 million people in the U.S. are currently diagnosed. Average age of onset tends to be in the late teens to early 20s for men and the late 20s to early 30s for women. Roughly 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness and changes in brain morphology. Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates and significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.