Also known as: olanzapine extended-release injectable suspension
Olanzapine is an atypical antipsychotic used primarily for schizophrenia and bipolar disorder, with additional approved combination indications. It is available in oral and intramuscular formulations and is marketed under the trade name Zyprexa among others. It was approved for medical use in the United States in 1996.
Teva said the FDA accepted its New Drug Application for long-acting olanzapine for schizophrenia, with a decision expected later this year. The company also reported Austedo sales of $2.26 billion in 2025 and plans six biosimilar launches in 2026 and 2027.
Researchers identify speech latency as a biomarker to enrich schizophrenia clinical trials, while a separate study finds clozapine more effective than alternatives for patients who fail initial antipsychotic treatment.
Teva and Sanofi reported durable 44-week efficacy for duvakitug in inflammatory bowel disease, while the FDA accepted Teva's application for TEV-749, a once-monthly olanzapine injection for schizophrenia.
The FDA has accepted Teva Pharmaceuticals' New Drug Application for TEV-'749, a once-monthly subcutaneous olanzapine injection for treating schizophrenia in adults, based on Phase 3 trial data showing efficacy consistent with existing formulations without requiring post-injection monitoring.
The FDA has accepted Teva and Medincell's New Drug Application for TEV-'749, a once-monthly subcutaneous olanzapine formulation for schizophrenia treatment that showed no need for post-injection monitoring in Phase 3 trials.
The FDA has accepted Teva and Medincell's New Drug Application for olanzapine extended-release injectable suspension (TEV-'749), a once-monthly subcutaneous treatment for schizophrenia in adults that showed no evidence for post-injection monitoring requirements.
The FDA has accepted Teva Pharmaceutical's New Drug Application for TEV-'749, a once-monthly subcutaneous olanzapine extended-release injectable suspension for treating schizophrenia in adults, supported by Phase 3 SOLARIS trial data.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07581405 |
GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07565428 |
Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications |
RECRUITING | PHASE3 |
| NCT07482891 |
An Exploratory Study on Efficacy and Safety of Fosaprepitant and Palonosetron Hydrochloride for Injection in Preventing CINV From Multi-Agent HEC |
RECRUITING | PHASE4 |
| NCT07442890 |
A Cohort Study on the Prevention of Nausea and Vomiting Induced by Concurrent Chemoradiotherapy for Lung Cancer Using Rolapitant and Palonosetron |
NOT_YET_RECRUITING | NA |
| NCT07413809 |
Prevention of Delayed CINV After Autologous Transplant: Olanzapine-Containing Regimen vs. Dexamethasone-Containing Regimen |
RECRUITING | PHASE3 |
| NCT07263191 |
A Study of Olanzapine in Participants With Bipolar Disorder. |
RECRUITING | |
| NCT07208305 |
Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting |
RECRUITING | PHASE3 |
| NCT06995508 |
Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial |
RECRUITING | PHASE2 |
| NCT06850454 |
Olanzapine Versus Placebo for Moderately Emetogenic Chemotherapy |
RECRUITING | PHASE3 |
| NCT06649214 |
A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia |
NOT_YET_RECRUITING | PHASE3 |
