India Pharma Outlook Team | Friday, 09 October 2026
Taking a pill every day has been a staple of schizophrenia treatment for a long time, but it can be difficult for patients and their caregivers to take medication on a daily basis.
Now, the most widely prescribed atypical antipsychotic for schizophrenia has a new option that could simplify the routine.
The U.S. Food and Drug Administration (FDA) has approved Teva Pharmaceuticals WELTRUZA, a once-monthly injection of olanzapine for adults with schizophrenia.
The new formulation is an alternative to the daily oral treatment. It is not necessary to use loading doses, further oral treatment, or routine post-injection monitoring. It provides a long-acting formulation in a region where adherence is an issue.
WELTRUZA is the first and only once-monthly subcutaneous injectable olanzapine approved for adults with schizophrenia, according to the announcement by Teva.
Teva anticipates the medicine will be available in the United States in the coming weeks, Reuters reported. Olanzapine has been used to treat schizophrenia for over 30 years. Patients using medication who need to take it every day, however, may have a difficult time taking the medication consistently over time.
Skipped doses will compromise symptom control and increase the risk of relapse. WELTRUZA is designed to overcome this problem by providing a long-acting formulation of olanzapine that releases the drug slowly.
SteadyTeq is a proprietary copolymer technology developed by French biotechnology firm Medincell that is used in the medicine. The approved formulation contains three strengths of once a month:
The medicine is injected under the skin and is an alternative to taking tablets every day.
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The FDA approval is based on the results of the Phase 3 SOLARIS trial. The study showed improvements in schizophrenia symptoms, illness severity and personal and social functioning, Teva said.
The trial also demonstrated the similar tolerability of the three doses of WELTRUZA. However, the monthly formulation does not eliminate the known safety concerns of olanzapine.
The most common side effects were:
Teva also reported weight gain and metabolic changes consistent with oral olanzapine, which included clinically significant weight gain. These risks will need to be taken into account by patients and clinicians when deciding on treatment.
WELTRUZA's administration needs set it apart from some of the current injectable treatment options. According to Teva, the medicine gets to therapeutic blood levels without loading doses, oral supplementation, or booster injections. The company also notes that there is no requirement for post-injection monitoring.
These features may alleviate some treatment-related logistical needs of patients, caregivers, and healthcare providers. Monthly treatment may also facilitate the planning of treatment by individuals who have trouble taking medication every day.
The approval also paves the way for Teva's collaboration with Medincell. WELTRUZA is the second U.S.-approved product the companies have made together, after the long-acting injectable risperidone, Uzedy, which was approved in 2023 by the U.S. Food and Drug Administration, Reuters reported.
Under the agreement with Teva, Medincell will receive up to USD 112 million in development and commercial milestone payments in addition to sales royalties.
WELTRUZA is a new method of administering a proven schizophrenia medication. The monthly schedule and streamlined administration requirements may help overcome practical issues with regular treatment, and its clinical safety profile will be a significant factor for patients and prescribers.
Editorial note: The article distinguishes the convenience of monthly dosing from the medicine's safety profile. It does not suggest that the injection eliminates olanzapine's existing risks or guarantees better adherence.
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