FDA accepts Teva and Medincell’s NDA for TEV-‘749, a once-monthly subcutaneous olanzapine LAI for schizophrenia. Phase 3 SOLARIS trial shows efficacy matching oral forms without REMS/post-injection monitoring needs; addressing adherence gaps.
Written By: Nikita Chaudhari, BPharm
Reviewed By: Pharmacally Editorial Team
Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries Ltd. and Medincell announced a major milestone: the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for olanzapine extended-release injectable suspension, known as TEV-‘749. This investigational therapy targets adults with schizophrenia, aiming to bridge a critical gap in long-term treatment adherence.
Schizophrenia
Schizophrenia affects how individuals think, feel, and behave, manifesting in symptoms like delusions, hallucinations, disorganized speech, and cognitive impairments. It impacts about 1% of the global population, with 3.5 million diagnosed cases in the U.S. alone. The condition often strikes in late teens to early 30s, featuring cycles of remission and relapse, around 80% of patients face multiple relapses in the first five years. These episodes heighten risks of functional decline, treatment resistance, brain changes, and costly hospitalizations. Poor adherence to daily oral antipsychotics, including widely used olanzapine, exacerbates this, as patients may lack insight into their illness.
Current long-acting injectable (LAI) olanzapine options require a Risk Evaluation and Mitigation Strategy (REMS), mandating administration in certified facilities and 3-hour post-injection monitoring due to risks like excessive sedation.
About TEV-‘749
TEV-‘749, a once-monthly subcutaneous injection, could eliminate these barriers. It leverages Medincell’s proprietary SteadyTeq™ copolymer technology for controlled, sustained release of olanzapine, a second-generation atypical antipsychotic proven effective against schizophrenia symptoms.
About Subcutaneous OLAnzapine Extended-Release Injection Study (SOLARIS)
The NDA draws from the Phase 3 SOLARIS trial, (NCT05693935) a multinational, multicenter, randomized, double-blind, placebo-controlled study in patients aged 18-64 with schizophrenia. In Period 1 (8 weeks), 675 participants received low, medium, or high doses of TEV-‘749 or placebo in a 1:1:1:1 ratio. Completers advanced to Period 2 (48 weeks), randomized equally across the three TEV-‘749 doses, with end-of-treatment and follow-up visits at 4 and 8 weeks post-last dose.
Week 56 results demonstrated efficacy comparable to oral olanzapine, no suspected or confirmed post-injection delirium/sedation syndrome (PDSS) events, and a long-term systemic safety profile consistent with other olanzapine formulations; eliminating the need for post-injection monitoring.
Eric Hughes (Teva EVP, Global R&D & CMO) emphasized poor adherence to oral olanzapine in schizophrenia patients as a key unmet need. He highlighted TEV-‘749’s potential as a once-monthly subcutaneous LAI, matching olanzapine’s efficacy/safety without prior formulation limits, and expressed eagerness for FDA review to close this care gap.
Christophe Douat (Medincell CEO) noted daily olanzapine’s widespread use and how TEV-‘749’s LAI could integrate better into patients’ lives. He stressed growing recognition of LAIs in psychiatry and the broad impact of a practical long-acting option.
TEV-‘749 remains investigational and unapproved. If approved, it could transform schizophrenia management by simplifying treatment, reducing relapses, and cutting healthcare burdens without REMS restrictions.
Reference
U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-‘749) for the Once-Monthly Treatment of Schizophrenia in Adults, 20 February 2026, Teva Pharmaceutical Industries Ltd. – U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-‘749) for the Once-Monthly Treatment of Schizophrenia in Adults
New Long-term Safety Data from the Completed Phase 3 SOLARIS Trial Support the Potential of Olanzapine LAI (TEV-‘749) as the First Long-Acting Olanzapine Treatment Option for Schizophrenia with No PDSS Observed, 20 September 2026, https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/New-Long-term-Safety-Data-from-the-Completed-Phase-3-SOLARIS-Trial-Support-the-Potential-of-Olanzapine-LAI-TEV-749-as-the-First-Long-Acting-Olanzapine-Treatment-Option-for-Schizophrenia-with-No-PDSS-Observed/default.aspx
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, https://clinicaltrials.gov/study/NCT05693935