Teva presents Phase 3 data on once-monthly olanzapine LAI TEV-'749
Teva Pharmaceuticals has presented new data from its Phase 3 SOLARIS trial of TEV-'749, a once-monthly subcutaneous long-acting injectable (LAI) formulation of olanzapine, at the Psych Congress meeting in New Orleans. The post hoc analyses, drawn from the trial's open-label safety stage, reported high rates of stabilisation and low relapse among participants with schizophrenia, as Teva positions itself for a US regulatory decision expected later this year.
The headline figures from the open-label period show that 231 of 411 participants (56%) achieved stabilisation across three dose groups. Of those who stabilised, only 10 (4%) subsequently relapsed. Among the 183 participants treated for six months or more, 39 (21%) met the study's remission criteria, defined as maintaining a PANSS item score of three or lower across eight specific items for at least six consecutive months.
What the data show
Separate pharmacokinetic simulations suggest that switching patients to TEV-'749 one day after their last dose of oral or short-acting intramuscular olanzapine produced olanzapine plasma exposures that stayed within established oral therapeutic ranges. Teva says this supports a direct switching approach without an oral overlap period, which could simplify initiation in both inpatient and outpatient settings.
A metabolic sub-analysis found that the weight and metabolic profile of TEV-'749 was broadly consistent with daily oral olanzapine, with no clear dose-dependent pattern detected. Olanzapine is well known to carry metabolic risks, so investigators and prescribers will monitor these outcomes closely in any post-marketing programme.
Eric Hughes, Executive Vice President of Global R&D and Chief Medical Officer at Teva, said the data "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."
Regulatory path and market context
TEV-'749 remains investigational and is not yet approved in any market. The FDA's Prescription Drug User Fee Act (PDUFA) target date falls in the fourth quarter of 2026. In the EU, the European Medicines Agency accepted Teva's Marketing Authorisation Application in May 2026. The formulation uses SteadyTeq, a copolymer controlled-release technology licensed from Medincell, whose first BEPO-based product, UZEDY (risperidone LAI), received FDA approval in April 2023.
The LAI antipsychotic market is competitive. Established once-monthly and once-every-three-month injectable options from Janssen (paliperidone palmitate, aripiprazole lauroxil) and Otsuka/Lundbeck already hold significant share. Teva's strategic argument rests on olanzapine's position as the most widely prescribed atypical antipsychotic in daily oral form globally, and on the hypothesis that a substantial portion of that oral patient population could benefit from a LAI formulation if adherence challenges are driving relapse. Post hoc data from an open-label extension carry inherent limitations compared with the pre-specified, blinded primary trial, and investors and clinicians will look to the full FDA review and post-marketing commitments before drawing firm conclusions about long-term differentiation.
Schizophrenia affects approximately 1% of the global population, and around 80% of patients experience multiple relapses within the first five years of treatment. The unmet need around adherence remains significant, and a well-tolerated monthly injectable backed by a recognised active ingredient could attract prescribers who are familiar with olanzapine's efficacy profile but wary of its oral adherence limitations.