Decades-Old Schizophrenia Drug Wins Approval For New Formulation

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The FDA approved Weltruza, a once-monthly subcutaneous formulation of olanzapine for adults with schizophrenia, Teva announced Oct. 9, 2026. The product does not require loading doses or post-injection monitoring for PDSS, though its label still lists PDSS as a warning and includes other significant safety risks.

The FDA approved Weltruza, a once-monthly subcutaneous injection of olanzapine for adults with schizophrenia, Teva Pharmaceuticals announced Oct. 9. The formulation does not require loading doses or post-injection monitoring for post-injection delirium/sedation syndrome (PDSS), a concern that has limited use of an earlier long-acting olanzapine product.

Weltruza delivers olanzapine, an antipsychotic that has been available in oral form for decades. Teva said the injectable is offered in 318 mg, 425 mg and 531 mg doses, corresponding to oral olanzapine doses of 10 mg, 15 mg and 20 mg. The company said the formulation can reach therapeutic blood levels without oral treatment alongside the injection, loading doses or booster injections.

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 study’s primary measure, the change in total score on the Positive and Negative Syndrome Scale (PANSS) from baseline to week eight. The placebo-adjusted differences ranged from −9.71 to −11.27 points, with P<0.001 for each comparison. Teva also reported better results than placebo on two secondary measures of clinical status and personal and social functioning.

No PDSS cases occurred in the trial, according to the source report. The reported safety profile was generally consistent with oral olanzapine. Common adverse events included weight gain, sleepiness, headache and constipation; injection-site reactions included induration, pain, redness, itching and swelling.

A Monthly Option Without Routine PDSS Monitoring

Olanzapine is widely used as an oral antipsychotic, but a daily regimen can be difficult for some people to maintain. A once-monthly injection offers a less frequent dosing schedule, which may be useful for patients and clinicians seeking an alternative to daily tablets. The approval adds another long-acting treatment choice; it does not establish that injections will suit every patient or improve outcomes for all people with schizophrenia.

The practical distinction is the monitoring requirement. The existing long-acting olanzapine product Zyprexa Relprevv carries a risk evaluation and mitigation strategy requiring three hours of observation after injection because of PDSS risk. Weltruza does not require that routine post-injection monitoring, according to the report. That difference could reduce a logistical barrier to using long-acting olanzapine, while the drug’s warnings and need for individualized clinical decisions remain.

How Weltruza Differs From Earlier Olanzapine

Olanzapine has been used as an oral treatment for schizophrenia for more than 30 years. Long-acting formulations are intended to reduce the need for daily dosing, but the earlier injectable olanzapine product has been associated with PDSS, a rare event involving symptoms such as agitation, anxiety and confusion after an injection. Reports have described people becoming disoriented or unusually sedated soon after treatment, prompting the required observation period for Zyprexa Relprevv.

Teva’s approval announcement and the trial results provide the basis for the new formulation’s use. The absence of PDSS cases in SOLARIS is a finding from that study, not proof that the risk cannot occur. The Weltruza labeling still lists PDSS among its warnings and precautions, alongside risks including neuroleptic malignant syndrome, metabolic changes, tardive dyskinesia, low blood pressure on standing, blood-cell abnormalities, seizures and cognitive or motor impairment.

“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

Safety Risks and Patient Fit Remain

The available information does not establish how widely Weltruza will be prescribed, how it will compare with other long-acting treatments in routine care, or whether its reduced monitoring burden will increase uptake. The trial’s lack of observed PDSS cases does not rule out the event after approval; PDSS remains on the product’s warning label.

Individual suitability, the full prescribing instructions and how clinicians will manage the listed risks require review of the official product labeling and clinical judgment. Antipsychotic treatment decisions should be made with a qualified health professional. The source material also does not provide launch timing, pricing or coverage details.

Launch Details and Prescribing Guidance

Teva’s announcement establishes the FDA approval, but the source report does not specify when Weltruza will be available to patients or provide pricing and insurance-coverage information. Those commercial details may shape access alongside the reduced post-injection monitoring requirement.

Clinicians and patients will need to consult the full prescribing information for dosing, administration and safety guidance. Further real-world experience may clarify how the product is used and whether its monthly schedule changes treatment patterns; the approval and trial findings alone do not answer those questions.

Key Questions

What did the FDA approve?

The FDA approved Weltruza, a once-monthly subcutaneous olanzapine injection for adults with schizophrenia, according to Teva.

Does Weltruza require monitoring after each injection?

The report says Weltruza does not require routine post-injection monitoring for PDSS. Its labeling nevertheless includes PDSS among the warnings and precautions.

What trial supported the approval?

Approval was supported by the phase III SOLARIS trial. Teva reported that all dose groups outperformed placebo on the PANSS total-score change from baseline to week eight.

What side effects were reported?

Common events reported in the trial included weight gain, sleepiness, headache and constipation. Injection-related reactions included pain, redness, itching, swelling and induration. The product label lists additional risks.

When will Weltruza be available?

The source report does not give a launch date, price or insurance-coverage information. Those details remain unreported.

Source: rss