Teva Pharmaceutical Industries Ltd (NYSE and TASE: TEVA) presented new post hoc data from the pivotal Phase 3 SOLARIS trial for its investigational once-monthly subcutaneous long-acting injectable (LAI) olanzapine, TEV-749. The findings were shared at Psych Congress in New Orleans on September 15, 2026, ahead of an anticipated FDA approval decision in Q4 2026.

The data focuses on the efficacy, safety, and durability of TEV-749 for treating schizophrenia in adults. Teva highlighted that more than half of participants achieved stabilization, with low relapse rates among those stabilized. Additionally, analyses support direct switching strategies from daily oral or short-acting intramuscular olanzapine to the monthly subcutaneous injection.

Stabilization and Remission Rates

In a post hoc analysis of the open-label safety stage of the SOLARIS trial, significant proportions of participants met key clinical endpoints. Among 411 participants receiving TEV-749, 231 (56%) achieved stabilization. The stabilization rates across dose groups were 61% for the 318-mg group, 54% for the 425-mg group, and 54% for the 531-mg group.

Among the 231 participants who achieved stabilization, only 10 (4%) experienced relapse. Relapse rates by dose group were 6% for the 318-mg group, 1% for the 425-mg group, and 5% for the 531-mg group. Furthermore, among 183 participants treated with TEV-749 for six or more months, 39 (21%) met criteria for remission. Remission rates were 26% for the 318-mg group, 13% for the 425-mg group, and 26% for the 531-mg group.

Switching Strategies and Safety

Separate analyses simulated potential switching scenarios for patients currently on other olanzapine formulations. Initiating TEV-749 one day after the last dose of oral or short-acting intramuscular olanzapine resulted in predictable olanzapine exposures within established therapeutic ranges. These findings provide clinical insights for healthcare providers managing transitions to the once-monthly injectable.

Metabolic outcome analyses indicated that the metabolic profile of TEV-749 was consistent with daily oral olanzapine formulations. No clear dose-dependent pattern was observed in these metabolic outcomes, supporting the broader safety and tolerability findings from the SOLARIS program.

What the Numbers Show

The divergence between stabilization and remission rates suggests that while a majority of patients achieve symptom control, sustained remission remains a higher threshold. With 56% of participants achieving stabilization but only 21% of those treated for six months or longer meeting remission criteria, the data indicates that long-term maintenance is distinct from initial acute response management.

Regulatory Outlook

TEV-749 utilizes SteadyTeq technology, a proprietary copolymer from Medincell that provides controlled, sustained release of olanzapine. The drug is not yet approved by any regulatory authority. A PDUFA decision from the US Food and Drug Administration is expected in Q4 2026. In Europe, the European Medicines Agency accepted the Marketing Authorization Application for TEV-749 in May 2026.

Teva Pharmaceuticals announced new data from a discrete choice experiment revealing that healthcare providers (HCPs) prioritize somnolence risk and short-term symptom improvement when selecting treatments for tardive dyskinesia (TD) in patients aged 55 years or older.

The findings, presented at Psych Congress in New Orleans from September 15 – 19, 2026, indicate that AUSTEDO (deutetrabenazine) had the highest predicted choice probability across all four patient profiles studied. This preference was driven primarily by the drug’s somnolence risk profile, duration of available data demonstrating long-term response, and drug-drug interaction characteristics.

HCP Preference Driven by Tolerability and Efficacy

In the study involving 489 HCPs across various specialties, participants evaluated key attributes driving their TD treatment preferences. The data highlighted specific decision-making weights assigned to different clinical factors:

HCPs adapted their prescribing criteria based on patient presentation settings. The risk of somnolence carried higher priority for outpatients previously in long-term care, accounting for up to 36.2% of decision weight, compared to up to 29.5% for those currently in long-term care settings.

What the Numbers Show

Somnolence risk and short-term symptom improvement collectively account for approximately 50% to 65% of the total decision-making weight identified in the study. This concentration suggests that tolerability and immediate efficacy are the dominant drivers for VMAT2 inhibitor selection in this demographic, outweighing logistical factors like dose formulation and drug-drug interaction risks combined.

Persistent Burden of Untreated TD

Also presented at the conference, an interim analysis from the IMPACT-TD Registry examined outcomes for individuals with probable TD who remained untreated with any VMAT2 inhibitor for 24 months. The data showed that TD burden persisted without spontaneous resolution:

• Approximately 89%–96% of participants experienced at least a mild global impact of TD.
• 60%–74% experienced moderate-to-severe impact.
• Most patients (55%–69%) reported stable or worsening TD severity relative to baseline.

Depression and anxiety scores fluctuated over the two-year period without sustained improvement.

Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva, stated that offering treatments with attributes valued by healthcare providers is essential for delivering effective, patient-centered care.

AUSTEDO XR and AUSTEDO are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia. Common adverse reactions include somnolence, diarrhea, dry mouth, and fatigue.