Teva’s investigational TEV-‘749 showed sustained stabilization and low relapse in the Phase 3 SOLARIS trial of adults with schizophrenia.
Written By: Anshu Gupta, PharmD
Reviewed By: Pharmacally Editorial Team
Teva Pharmaceuticals presented new clinical data supporting the long-term durability and treatment-switching potential of TEV-‘749, an investigational once-monthly subcutaneous long-acting injectable (LAI) formulation of olanzapine for adults with schizophrenia. The findings from the Phase 3 SOLARIS program, presented at Psych Congress 2026, showed that more than half of participants receiving TEV-‘749 achieved stabilization, while relapse was uncommon among those who stabilized.
Long-Term Data Show Sustained Stabilization
The post hoc analysis evaluated participants who entered the open-label long-term treatment period of SOLARIS. Among 411 participants receiving TEV-‘749, 231 (56%) achieved stabilization across the three dose groups.
Among the 231 participants who achieved stabilization, only 10 (4%) subsequently experienced relapse. Relapse occurred in 6%, 1%, and 5% of participants in the 318-, 425-, and 531-mg dose groups, respectively.
The analysis also assessed remission among participants treated with TEV-‘749 for at least six months. Of 183 eligible participants, 39 (21%) met the study’s remission criteria. Remission required maintaining a Positive and Negative Syndrome Scale (PANSS) item score of 3 or lower for at least six consecutive months across eight specified remission items.
Because these analyses were post hoc and conducted during the open-label period, the findings provide supportive long-term clinical context rather than establishing comparative efficacy against another treatment.
Subcutaneous Delivery Could Address an Important Olanzapine LAI Limitation
The route of administration is an important part of TEV-‘749’s clinical profile. Existing long-acting injectable olanzapine formulations are administered intramuscularly and carry a risk of post-injection delirium/sedation syndrome (PDSS). This safety concern requires post-injection monitoring under an FDA-mandated Risk Evaluation and Mitigation Strategy (REMS).
TEV-‘749 uses a subcutaneous route and a controlled-release formulation. In the SOLARIS program, Teva reported no suspected or confirmed PDSS events through Week 56 across 3,470 injections. While these findings do not establish that TEV-‘749 categorically eliminates PDSS risk, they provide important clinical context for its differentiated administration profile.
The formulation uses SteadyTeq, a proprietary copolymer technology from Medincell that provides controlled, sustained release of olanzapine following subcutaneous administration.
Switching Analyses Support Direct Transition Strategies
Separate population pharmacokinetic simulations evaluated switching from daily oral olanzapine or short-acting intramuscular olanzapine to TEV-‘749.
The analyses found that initiating TEV-‘749 one day after the final dose of either formulation produced predictable olanzapine exposure within established oral therapeutic ranges. These findings provide pharmacokinetic support for direct switching strategies and may be particularly relevant for patients currently stabilized on daily oral olanzapine.
The treatment-switching data also address an important practical consideration for LAI therapy: maintaining therapeutic olanzapine exposure during the transition between formulations. If supported by the final prescribing information, such an approach could simplify conversion from daily treatment to monthly administration.
An additional analysis of body weight and metabolic outcomes found a metabolic profile consistent with daily oral olanzapine, with no clear dose-dependent pattern observed.
SOLARIS Evaluated Monthly Subcutaneous Olanzapine
SOLARIS was a multinational, randomized, double-blind, parallel-group, placebo-controlled Phase 3 study involving adults aged 18 to 64 years with schizophrenia.
During the initial eight-week treatment period, 675 patients were randomized equally to low-, medium-, or high-dose once-monthly subcutaneous olanzapine LAI or placebo. Patients who completed the placebo period were subsequently randomized to one of the three active dose groups, while those already receiving active treatment continued their assigned dose for the following 48 weeks.
The primary efficacy endpoint was change in PANSS, with additional assessments using the Clinical Global Impression-Severity scale and Personal and Social Performance scale. The second treatment period also evaluated longer-term safety and tolerability.
FDA Decision Expected in Q4 2026
The new findings expand the clinical evidence supporting TEV-‘749 as a potential monthly alternative to daily oral olanzapine. Christoph Correll, MD, of the Zucker School of Medicine at Hofstra/Northwell, highlighted the potential value of a monthly olanzapine formulation for patients currently receiving daily oral therapy.
TEV-‘749 remains investigational and has not been approved by any regulatory authority. The FDA accepted Teva’s New Drug Application (NDA) for TEV-‘749 in February 2026, initiating the agency’s regulatory review under the Prescription Drug User Fee Act (PDUFA) timeline. The FDA is expected to issue its decision in Q4 2026. In Europe, the European Medicines Agency accepted Teva’s Marketing Authorization Application for TEV-‘749 in May 2026, advancing the once-monthly subcutaneous olanzapine formulation into regulatory review in the EU.
If approved, TEV-‘749 would introduce a subcutaneous, once-monthly olanzapine LAI option, with the potential to simplify long-term administration while addressing some of the practical limitations associated with existing olanzapine LAI therapy.
Reference
Teva Announces New Olanzapine LAI (TEV-‘749) Post Hoc Data Highlighting High Rates of Stabilization and Long-Term Efficacy as Once-Monthly Subcutaneous Injectable for the Treatment of Schizophrenia in Adults, Teva, 18 September 2026
A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label, Long-Term Safety Phase to Evaluate the Efficacy and Safety of TV-44749 in Adults With Schizophrenia (SOLARIS), ClinicalTrials.gov ID NCT05693935
About the Writer
Anshu Gupta (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, regulatory affairs, and medical writing. She has presented research at academic conferences and completed certifications in Good Clinical Practice (GCP), ICH-GCP, and drug safety. Passionate about clinical trials and evidence-based medicine, she is committed to translating scientific evidence into accurate, reliable, and accessible healthcare content.