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The FDA approved Weltruza, a once-monthly subcutaneous olanzapine injection for adults with schizophrenia, Teva announced on October 9, 2026. The formulation does not require loading doses or post-injection monitoring, but its label still lists post-injection delirium/sedation syndrome among warnings and includes other established olanzapine risks.
The FDA has approved Weltruza, Teva Pharmaceuticals’ once-monthly subcutaneous formulation of olanzapine for adults with schizophrenia, the company announced October 9. Unlike an older long-acting olanzapine injection, the new product does not require loading doses or routine post-injection monitoring, offering a less frequent dosing option for a drug commonly taken by mouth every day.
Weltruza is available in 318 mg, 425 mg and 531 mg doses, corresponding to approved oral olanzapine doses of 10 mg, 15 mg and 20 mg, respectively, according to the report. Teva says the formulation can reach therapeutic blood levels without oral cotreatment, loading doses or booster injections. The dosing schedule may suit some patients who have difficulty maintaining daily medication routines or prefer less frequent treatment, though individual treatment decisions depend on clinical circumstances.
The approval was supported by the phase III SOLARIS trial. In results described in a 2024 Teva press release, each dose group outperformed placebo on the trial’s primary measure, change in total score on the Positive and Negative Syndrome Scale (PANSS). From baseline to week eight, the reported differences between treatment and placebo ranged from -9.71 to -11.27 points, with P<0.001 for all comparisons. The company also reported better results than placebo on key secondary measures of clinical impressions and personal and social functioning.
No cases of PDSS occurred in SOLARIS, according to the source report. However, the new product’s labeling still includes post-injection delirium/sedation syndrome among its warnings and precautions. Reported common adverse events included increased weight, sleepiness, headache and constipation. Injection-site reactions included hardening, pain, redness, itching and swelling. The label also lists other potential risks associated with olanzapine and antipsychotic treatment.
A Monthly Option Without Routine Monitoring
Olanzapine has been used for schizophrenia for decades, and oral olanzapine is described in the report as the most widely prescribed atypical antipsychotic. A monthly formulation could reduce the number of medication-taking occasions for patients who choose it with their clinicians. That may be relevant where daily dosing is a barrier, but approval alone does not establish that the new injection will improve adherence or outcomes for every patient.
The monitoring difference sets Weltruza apart from the older long-acting olanzapine product Zyprexa Relprevv, which carries a risk evaluation and mitigation strategy requiring three hours of observation after injection because of PDSS risk. The newer product’s lack of a routine monitoring requirement may reduce a practical burden for patients and clinics. Still, the warning remains in Weltruza’s labeling, and the available trial report describes no PDSS cases rather than proving the risk is absent.
Weltruza also retains olanzapine’s important safety considerations. Its boxed warning notes an increased mortality risk in elderly patients with dementia-related psychosis. Other listed concerns include metabolic changes, tardive dyskinesia, neuroleptic malignant syndrome, seizures and possible impairment of cognition or motor skills. The new route and schedule do not remove the need for prescriber review of benefits and risks.
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From Daily Tablets to Long-Acting Injections
Olanzapine is an established antipsychotic available in oral form and in long-acting injectable formulations. Daily oral treatment can pose adherence challenges, while some patients may favor less frequent dosing. The FDA action concerns a new delivery formulation of the existing drug, not a newly developed active ingredient.
One earlier long-acting olanzapine injection, Zyprexa Relprevv, has been associated with the need for post-injection observation under its risk-management program. PDSS can involve symptoms such as agitation, anxiety and confusion, with reports of serious sedation or disorientation shortly after treatment. Weltruza’s trial results and labeling address that safety issue, but the label continues to mention PDSS as a potential warning.
The source report says SOLARIS assessed symptom and functioning outcomes against placebo. Its reported efficacy results cover the first eight weeks from baseline, and the report does not provide further details here about longer-term outcomes or how the FDA weighed individual safety findings in its review.
“Adherence continues to be a major barrier to stability, particularly for those who rely on daily oral medications.”
— Christoph Correll, MD, Zucker School of Medicine at Hofstra/Northwell, in Teva’s press release
Schizophrenia medication injection
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Safety Questions After Approval
The source material does not specify when Weltruza will be available, its price, insurance coverage or how it will be distributed. It also does not provide detailed long-term trial results or comparisons with other long-acting treatments. These details will affect how accessible the new option is and how clinicians weigh it against existing choices.
Although no PDSS cases were reported in SOLARIS, the labeling still identifies the syndrome as a warning. The available information does not establish how often PDSS might occur in broader use. The report also does not give enough detail to assess the trial’s full participant profile or the duration of safety follow-up.
Long-acting antipsychotic injection
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Availability and Prescribing Details
Teva’s next practical steps are expected to include communicating launch timing and access details, including pricing and coverage information. Clinicians and patients will also need to consult the approved prescribing information for the complete dosing instructions, contraindications and safety warnings.
As use begins, post-approval experience may add information about how the injection performs in routine care, including tolerability and any reports of PDSS. For now, the confirmed development is the FDA approval; broader uptake, comparative benefits and real-world safety remain to be established.
Post-injection delirium sedation syndrome treatment
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Key Questions
What did the FDA approve?
The FDA approved Weltruza, a once-monthly subcutaneous injection of olanzapine for adults with schizophrenia, Teva announced October 9, 2026.
Does Weltruza require post-injection monitoring?
The source report says Weltruza does not require routine post-injection monitoring or loading doses. Its label still lists post-injection delirium/sedation syndrome as a warning, despite no cases being reported in the SOLARIS trial.
What doses are available?
The reported doses are 318 mg, 425 mg and 531 mg, corresponding to oral olanzapine doses of 10 mg, 15 mg and 20 mg, respectively.
What side effects were reported?
Common adverse events in the trial included increased weight, sleepiness, headache and constipation. Injection-site reactions included hardening, pain, redness, itching and swelling. The product also carries broader olanzapine warnings, including a boxed warning about increased mortality risk in elderly patients with dementia-related psychosis.
When will Weltruza be available?
The source report does not give a launch date, price or insurance coverage details. Those access details remain unclear.
Source: rss
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