Teva Announces U.S. Food and Drug Administration (FDA) Approval of WELTRUZA™ (Olanzapine) For Extended-Release Injectable Suspension, as the First and Only Once-Monthly Subcutaneous Injectable Olanzapine for Adults with Schizophrenia

PARSIPPANY, N.J. and TEL AVIV, Israel, Oct. 09, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved WELTRUZA (olanzapine) for extended-release injectable suspension, a new, once-monthly, subcutaneous long-acting injectable (LAI) for the treatment of schizophrenia in adults. WELTRUZA clinical trial results demonstrated improvement in symptoms (PANSS), significant reduction in illness severity (CGI-S), as well as improvement in personal and social functioning (PSP). In the coming weeks, WELTRUZA will be available in three different strengths (318 mg, 425 mg, 531 mg) with no loading doses, no oral supplementation and no post-injection monitoring required.

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“WELTRUZA offers the proven efficacy of olanzapine in an innovative long-acting subcutaneous injectable, helping to fill a major, long-standing gap in the schizophrenia treatment landscape,” said Chris Fox, Executive Vice President, U.S. Commercial and Head of Innovative Franchise at Teva. “WELTRUZA was developed with the patient in mind from day one and it is a powerful demonstration of what is possible when the needs of the patient guide the development of a truly innovative medicine. This important milestone also helps further Teva’s Pivot to Growth strategy.”

Olanzapine is the most widely prescribed atypical antipsychotic for schizophrenia as a daily oral treatment. However, it is well documented that daily options may make it difficult to sustain long-term symptom improvement due to challenges with adherence, increasing the risk for instability and relapse. WELTRUZA was developed to address this significant unmet need by offering the established efficacy of olanzapine in a once-monthly subcutaneous injectable formulation.

“This approval reflects the strength of patient-centric innovation at Teva and what our R&D organization can deliver,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “WELTRUZA combines proven science and novel formulation innovation to eliminate the need for monitoring after each injection, addressing a significant barrier to treatment and advancing care for people living with schizophrenia.”

WELTRUZA will be available in once-monthly subcutaneous injectable doses of 318 mg, 425 mg and 531 mg that correspond to the approved daily dose range of oral olanzapine of 10 mg, 15 mg and 20 mg, respectively.

“Olanzapine has been a trusted and foundational treatment option for people living with schizophrenia for more than 30 years, but adherence continues to be a major barrier to stability, particularly for those who rely on daily oral medications,” said Christoph Correll, MD, Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY. “By offering a subcutaneous long-acting injectable formulation with achievement of therapeutic blood levels without oral cotreatment, loading doses or booster injections, this new treatment option can help empower patients, support their care partners and provide clinicians with an important new tool to assist in managing this complex condition more effectively.”

In the Phase 3 SOLARIS trial, all three doses of WELTRUZA were similarly tolerated, with the most common reported adverse events (AEs) inclusive of increased weight, somnolence, headache, constipation and injection site reactions. Weight gain and metabolic changes were observed and were consistent with the systemic safety profile of oral olanzapine, including clinically significant weight gain. Discontinuations of WELTRUZA due to common AEs were consistent with placebo at 5% and 4% of trial participants, respectively. Please refer to the Important Safety Information below for additional safety information.

An estimated 2.1 million people are currently diagnosed with schizophrenia in the U.S. It is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and behaves. Schizophrenia is a complex medical condition that may require switching from oral options or between long-acting injectable options during the treatment journey.

WELTRUZA utilizes SteadyTeq, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine.

WELTRUZA will be available in the U.S. in the coming weeks.

The European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) for olanzapine long-acting injectable (TEV-‘749) for the treatment of schizophrenia in adults in May 2026. The EMA submission is supported by an extensive clinical development program, including the Phase 3 SOLARIS study. TEV-‘749 is not approved by the EMA at this time.

Teva Investor CallTeva will hold an investor call and live webcast tomorrow, Friday, October 9, 2026, at 8:00 a.m. ET/ 2:00 p.m. CET. To participate, please register in advance here. To access a live webcast of the presentation, visit Teva’s Investor Relations website. An archived version of the webcast will be available 24 hours after the end of the live discussion.

APPROVED USE

WELTRUZA (olanzapine) for extended-release injectable suspension is a prescription medicine used in adults for the treatment of schizophrenia.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about WELTRUZA?

WELTRUZA can cause serious side effects, including an increased risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). WELTRUZA is not for the treatment of people with dementia-related psychosis.

WELTRUZA may cause serious side effects, including:

• Post-injection delirium/sedation syndrome (PDSS) is a serious problem that can happen when too much olanzapine enters the bloodstream too quickly. PDSS has happened in people who received another extended-release olanzapine medicine by injection into their muscles (intramuscularly). WELTRUZA is injected under the skin (subcutaneously). It is not known whether PDSS can happen with WELTRUZA. PDSS with an extended-release intramuscular injection has led to hospitalization, has happened within the first 3 hours of injection, but also happened after 3 hours of injection, and has the risk each time an injection is received. Tell your healthcare provider right away or go to the nearest emergency room if you get signs or symptoms of PDSS, including more sleepiness than usual, dizziness, confusion or disorientation, trouble walking or talking, stiff muscles or shakiness, weakness, feeling grouchy or angry, feeling anxious or nervous, increased blood pressure, seizures (convulsions), or passing out.
• Strokes in elderly people (cerebral problems) that can lead to death.
• Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Seek medical attention right away if you have any of these symptoms: high fever, stiff muscles, confusion, changes in pulse, heart rate, or blood pressure, increased sweating.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS is an allergic reaction that can cause death that may affect your skin or other parts of your body including your liver, kidney, lungs, or heart. Contact your healthcare provider right away if you experience any signs or symptoms of DRESS, including fever, skin rash or blistering or peeling skin, swelling of face, glands, or other body parts, cough or trouble breathing, chest pain, yellowing of the skin or eyes, dark urine or changes in urination.
• Problems with your metabolism that may include high blood sugar (hyperglycemia), diabetes mellitus, changes in the fat levels in your blood (dyslipidemia), and weight gain. Extremely high blood sugar can lead to coma or death. If you have diabetes or are at risk of diabetes (e.g., obesity, family history of diabetes), your healthcare provider should check your blood sugar before you start and during treatment with WELTRUZA. Call your healthcare provider if you have symptoms of high blood sugar, including feeling very thirsty, hungry, sick to your stomach, weak or tired, or confused; needing to urinate more than usual; or your breath smells fruity.
• Uncontrolled facial or body movements (tardive dyskinesia) that may not go away, even if you stop receiving WELTRUZA. Tell your healthcare provider if you get any body movements that you cannot control.
• Decreased blood pressure (orthostatic hypotension). You may feel dizzy or lightheaded, get a fast or slow heartbeat, or faint, when you rise too quickly from a sitting or lying position. Drinking alcohol and using other medicines that make you dizzy can increase your risk for orthostatic hypotension. Avoid drinking alcohol during treatment with WELTRUZA.
• Falls. WELTRUZA may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.
• Low white blood cell counts. Your healthcare provider may do white blood cell count tests during your first few months of treatment with WELTRUZA.
• Difficulty swallowing that can cause food or liquid to get into your lungs.
• Seizures (convulsions).
• Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Do not drive, operate machinery, or do other dangerous activities until you know how WELTRUZA affects you.
• Problems controlling your body temperature so that you feel too warm. Avoid getting overheated or dehydrated.
• Certain side effects from the way WELTRUZA works in your body such as constipation, dry mouth, fast heartbeat, urinary retention, or prostate and bowel problems. Your risk is increased if you take other medicines that also cause these side effects.
• Increased prolactin levels in your blood (hyperprolactinemia). WELTRUZA can cause a rise in the blood levels of a hormone called prolactin that may cause side effects including missed menstrual periods, a reversible reduction in fertility in females who are able to become pregnant, leakage of milk from the breasts, development of breasts in men, or problems with erection.

The most common side effects of olanzapine in patients with schizophrenia include weight gain, sleepiness, headache, and constipation. Injection site reactions, including hardness, pain, redness, itching, and swelling, were reported with WELTRUZA.

These are not all the possible side effects with WELTRUZA. Tell your healthcare provider if you have any side effect that does not go away. For more information, ask your healthcare provider or pharmacist.

Before receiving WELTRUZA, tell your healthcare provider about all of your medical conditions, including if you:

• have or had diabetes or high blood sugar
• have or had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low HDL levels in your blood
• have or had low or high blood pressure
• have or had heart problems or stroke
• are dehydrated
• have or had a low white blood cell count
• have or had seizures (convulsions)
• have or had problems with urination or prostate problems
• have Alzheimer’s disease
• have or had constipation or bowel obstruction
• have or had breast cancer
• are pregnant or plan to become pregnant. WELTRUZA may harm your unborn baby. Receiving WELTRUZA during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms such as agitation, stiffness or floppiness, tremors, sleepiness, and breathing or feeding problems after birth. Talk to your healthcare provider about the risks to your baby if you receive WELTRUZA during pregnancy.
  • If you become pregnant during treatment with WELTRUZA, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
  • have or had diabetes or high blood sugar
  • have or had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low HDL levels in your blood
  • have or had low or high blood pressure
  • have or had heart problems or stroke
  • are dehydrated
  • have or had a low white blood cell count
  • have or had seizures (convulsions)
  • have or had problems with urination or prostate problems
  • have Alzheimer’s disease
  • have or had constipation or bowel obstruction
  • have or had breast cancer
  • are pregnant or plan to become pregnant. WELTRUZA may harm your unborn baby. Receiving WELTRUZA during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms such as agitation, stiffness or floppiness, tremors, sleepiness, and breathing or feeding problems after birth. Talk to your healthcare provider about the risks to your baby if you receive WELTRUZA during pregnancy.
    • If you become pregnant during treatment with WELTRUZA, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
  • are breastfeeding or plan to breastfeed. WELTRUZA passes into breast milk. If you breastfeed during treatment with WELTRUZA, tell your healthcare provider if your baby is very sleepy, irritable, is feeding poorly, or gets tremors or abnormal muscle movements. Talk to your healthcare provider about the best way to feed your baby during treatment with WELTRUZA.

  Tell your healthcare provider about all the medicines you take or plan to take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: blood pressure medicines, levodopa or dopamine, or other olanzapine medicines. Your healthcare provider can tell you if it is safe to receive WELTRUZA with your other medicines.

  Do not start or stop any medicines during treatment with WELTRUZA without talking to your healthcare provider first.

  You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

  For more information about WELTRUZA, see the full Prescribing Information, including Medication Guide and Boxed WARNING, or talk to your healthcare provider.

  About Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS)SOLARIS was an 8 week, multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-64 years) with schizophrenia. For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (WELTRUZA) (low, medium or high dose) or placebo in a 1:1:1:1 ratio. For period two (next 48 weeks), patients who completed period one on placebo were re-randomized and equally allocated to one of the three olanzapine LAI (WELTRUZA) treatment groups, while patients who completed period one on active olanzapine LAI (WELTRUZA) remained on their established dose strength. The end-of-treatment and follow-up visits were 4 and 8 weeks after administration of the last treatment dose, respectively. The primary objective of the Phase 3 SOLARIS study was to evaluate the efficacy of olanzapine LAI (WELTRUZA) in adult patients with schizophrenia, as measured by PANSS. A key secondary objective was to further evaluate the efficacy of olanzapine LAI (WELTRUZA) based on additional parameters in adult patients with schizophrenia, as measured by CGI-S and PSP. A secondary objective of period two of the study was to evaluate the safety and tolerability of olanzapine LAI (WELTRUZA) in adult patients with schizophrenia.

  About SchizophreniaSchizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts. Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability. Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 2.1 million people in the U.S. are currently diagnosed with the condition. 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. 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. 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. 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.

  About TevaTeva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

  Cautionary Note Regarding Forward-Looking StatementsThis Press Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize WELTRUZA for the treatment of schizophrenia in adults; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and to profitably commercialize our innovative medicines and biosimilar portfolio, whether organically or through business development; our significant indebtedness; our business and operations in general; compliance, regulatory and litigation matters; financial, economic and other risks; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors” and “Other Information.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

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  8. Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.
  9. Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The Am J Psychiatry, 170(6), 609–615.

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