Teva and Medincell Receives FDA Acceptance for Once-Monthly Olanzapine Injection for Schizophrenia
Saturday, February 21, 2026
Teva Pharmaceutical Industries and Medincell have announced that the U.S. Food and Drug Administration has accepted their New Drug Application (NDA) for TEV-’749, an investigational olanzapine extended-release injectable suspension for the once-monthly treatment of adults with schizophrenia.
TEV-’749 is designed as a long-acting injectable (LAI) formulation of olanzapine, administered subcutaneously. The aim is to improve treatment adherence and help maintain long-term symptom stability in people with schizophrenia.
SOLARIS was a multinational, randomised, double-blind, placebo-controlled Phase 3 trial involving 675 adults aged 18 to 64 with schizophrenia. During the initial eight-week period, participants received either once-monthly TEV-’749 at varying doses or placebo. In the subsequent 48-week period, eligible participants continued treatment with one of the active dose groups.
Schizophrenia is a long-term and often severe mental health condition that affects thinking, emotions and behaviour. Symptoms may include hallucinations, delusions, disorganised speech and cognitive difficulties. Around 1% of the global population is expected to develop schizophrenia during their lifetime. In the United States, approximately 3.5 million people are currently diagnosed with the condition.
The regulatory filing is supported by Phase 3 data evaluating the product’s efficacy, safety and tolerability.
The NDA is supported by data from the Phase 3 SOLARIS study. In this trial, TEV-’749 demonstrated an efficacy and safety profile consistent with existing olanzapine treatments. The study did not show evidence suggesting the need for post-injection monitoring.
TEV-’749 uses SteadyTeq™, a proprietary copolymer technology developed by Medincell to enable sustained and controlled release of olanzapine. The product remains investigational and has not yet been approved by any regulatory authority.
The illness is typically marked by periods of remission and relapse. Many patients experience repeated relapses within the first five years of treatment, often linked to poor adherence to medication.
Each relapse may increase the risk of reduced functioning and further complications, highlighting the need for treatment options that support consistent, long-term care.
Source: tevapharm.com
