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Phase 3 clinical trials are larger trials typically conducted with up to several thousand participants and are designed to establish if the intervention is safe and effective in preparation for product approval. The results show whether or not the intervention is beneficial to a particular group of participants.
TEV-‘749 is an investigational once-monthly subcutaneous long-acting injectable (LAI) of the 2nd generation antipsychotic olanzapine. SteadyTeq™, a copolymer technology proprietary to Medincell, provides a controlled steady release of olanzapine. TEV-‘749 is not approved by any regulatory authority for any use and its safety and efficacy are not established.
With nearly 30 years of clinical and real-world use, olanzapine is one of the most commonly prescribed 2nd generation oral antipsychotics for schizophrenia around the world.7 Its efficacy and safety profiles are well established.
Schizophrenia is a complex medical condition that may require switching from oral options or between different LAI options during the patient treatment journey.
Currently, the only long-acting olanzapine treatment option for schizophrenia carries a risk for Post-injection delirium/sedation syndrome (PDSS), the sudden and unexpected onset of delirium or sedation when medication is released too quickly into the blood after receiving an intramuscular injection of long-acting olanzapine.1
About Schizophrenia
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.1 Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.1,2,3 Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 3.5 million people in the U.S. are currently diagnosed with the condition.2,3 Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men, and the late 20s to early 30s for women.3 The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization.3 Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.4,5,6 Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates, and ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.1,2,3,4,5,6
1 Data on file. Parsippany, NJ: Teva Neuroscience, Inc.
2 Substance Abuse and Mental Health Services Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia. Accessed November 2023.
3 Velligan DI, Rao S. The epidemiology and global burden of schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5
4 Wander C. (2020). Schizophrenia: opportunities to improve outcomes and reduce economic burden through managed care. The American journal of managed care, 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013
5 Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric disease and treatment, 14, 205–223.
6 Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.
7 NPA TRx - MAT Jan 2024; schizophrenia factors sourced from 2022 Analytics Link (IQVIA)
Teva Presents New Phase 3 Efficacy, Safety and Tolerability Data from SOLARIS Trial Evaluating TEV-‘749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable for Adult Patients Diagnosed with Schizophrenia
Teva and Medincell Announce Positive Phase 3 Efficacy Results from SOLARIS Trial Evaluating TEV-‘749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable in Adults with Schizophrenia
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Phase 2 clinical trials are conducted with up to several hundred participants. They are designed to collect additional information about whether the intervention is safe and effective. The results of these types of clinical trials may be used to design future trials or to develop additional research methods.
Phase 1 clinical trials are small-scale clinical trials with very few participants to examine the way the intervention (e.g., medication) interacts with the human body. The purpose of the study is to collect information about the safety of the interventions assessed. These trials are typically conducted in healthy participants without a specific medical condition.
More information about this phase in drug development.
Teva innovative medicine and biosimilar pipeline by development stage, excluding country / regional launches of products submitted or under review in new markets.
Pipeline is current as of July 2024.
In collaboration with MODAG.
In collaboration with Sanofi.
In collaboration with Alvotech for the U.S. market.
In collaboration with Launch Therapeutics.
In collaboration with mAbxience.
BLA filed with FDA, MAA file for EU in preparation.