The US Food and Drug Administration approved Weltruza, a long-acting olanzapine injection given under the skin, for adults with schizophrenia, according to Teva's announcement of 9 October 2026. The approval is American only. Teva says the European Medicines Agency has not approved it, and no UK authorisation was found on 14 October 2026.
One randomised phase 3 study carries the decision. The SOLARIS trial, sponsored and funded by Teva, enrolled 675 adults aged 18 to 64 at 82 sites in 5 countries, none of them in the UK. After 8 weeks, symptom scores fell by 9.75 to 11.27 points more in the 3 olanzapine groups than in the placebo group, on a scale that runs from 30 to 210. That was the pre-registered primary endpoint.
A safety rule, not a new medicine, is the reason the product exists. Olanzapine tablets have been authorised in the European Union since 1996, and an injected form, olanzapine pamoate, is already sold. That older injection carries a rare reaction called post-injection delirium sedation syndrome, or PDSS, so every dose must be followed by 3 hours of supervision. Weltruza is approved without that requirement.
What the FDA approved on 9 October 2026
Teva's statement gives the indication as the treatment of schizophrenia in adults. Weltruza is olanzapine for extended-release injectable suspension, developed under the code TEV-'749 and known in the trial as TV-44749. The release mechanism, a copolymer depot called SteadyTeq, belongs to Medincell, the company that partnered with Teva on the product.
Two things are missing from the public record so far. The FDA's own approval documents were not found on 14 October 2026, and DailyMed, the US label database, returned no entry for Weltruza when it was searched that day. Every detail of the licence here therefore comes from Teva, a company statement and not evidence in itself. The full prescribing information and the FDA review documents, once posted, will show the reviewers' reservations.
According to Teva, the label carries the class warning shared by antipsychotics: a higher risk of death in elderly people with dementia-related psychosis, for whom the product is not approved. On PDSS the company quotes its own label as saying it is not known whether the syndrome can happen with Weltruza. Teva says the medicine will reach US pharmacies in the coming weeks. No price was published.
The SOLARIS numbers in absolute terms
Results were posted to the SOLARIS registry entry, NCT05693935, on 9 January 2026.
First posted on 23 January 2023, the entry lists one primary outcome: the change in the Positive and Negative Syndrome Scale, or PANSS, from baseline to week 8. Each of 3 dose groups held about 169 people, against a placebo group of 168, and the trial was quadruple-blind.
On that endpoint the placebo group improved by 12.17 points. The 3 olanzapine groups improved by 21.91, 23.44 and 21.93 points. The differences from placebo were 9.75, 11.27 and 9.76 points, each with a p value below 0.0001 and a 95% confidence interval that stays well clear of zero. These are absolute differences in scale points. No relative figure was reported, and none is needed.
Statistical significance says the gap is unlikely to be chance. Whether 10 points on a 30 to 210 scale is meaningful to a patient is a separate clinical question, which the registry does not address and which this article does not settle. The 2 key secondary endpoints, a clinician's rating of illness severity and a scale of social functioning, moved in the same direction in every dose group.
For anyone reading from Britain, the population matters. Of the 675 people randomised, 75.1% were men and 68.4% were recorded as Black or African American. Of the 82 sites, 53 were in the United States, with the rest in Bulgaria, China, Romania and Turkey. The comparator was placebo, so SOLARIS says nothing about how Weltruza performs against oral olanzapine or any other long-acting injection.
Where the announcement and the registry differ
Teva's announcement describes discontinuations for adverse events as consistent with placebo. The registry bears that out for the double-blind period: 5 people stopped for an adverse event on placebo and 2 to 4 in each olanzapine group. More people left for other reasons, and that is the bigger story in the same table. Across all 4 groups, 199 of 675 participants, or 29.5%, did not complete 8 weeks. Withdrawal by the participant, 125 people, was the commonest reason.
Adverse events as a whole were not similar. In the double-blind period 50.3% of the placebo group reported any adverse event, against 68.7%, 69.6% and 74.6% in the olanzapine groups. Weight gain was reported for 7.8% on placebo and 30.1% to 39.3% on olanzapine. Sleepiness was reported for 1.8% on placebo and 6.0% to 9.8% on olanzapine. Injection site pain ran at 4.2% on placebo and up to 11.3% on the medicine.
None of that is unexpected from olanzapine, whose effect on weight and metabolism is the familiar trade-off of the drug. It is still the half of the picture that a press release leaves out. Over the full 60 weeks of the integrated safety data, 36 of 604 people given the medicine, or 6.0%, had a serious adverse event, 2 had diabetic ketoacidosis and 3 of 611 died. The registry does not assign cause.
Long-term data are thinner than they sound. Of 423 people who entered the 48-week open-label period, 135, or 31.9%, completed it. In an open-label phase without a comparator, those results describe tolerability over time. They cannot show that benefit persists.
A third gap is the literature itself. A PubMed search on 14 October 2026 found 4 papers on the product: a phase 1 pharmacokinetic study, a dose-selection model, a laboratory study of the depot and a survey of trial participants. All were written or funded by Teva. No peer-reviewed report of the SOLARIS efficacy results was found. The registry also records a restrictive publication agreement that lets the sponsor review a manuscript 60 days before submission.
How Weltruza differs from the existing olanzapine injection
Olanzapine pamoate, sold as Zyprexa Relprevv in the United States and Zypadhera in Europe, is the comparison that defines this product. Both versions carry the same burden. The FDA's risk programme for Zyprexa Relprevv, last updated on 6 July 2026, requires that each injection be given in a certified healthcare setting with continuous monitoring for at least 3 hours, and that the patient leave accompanied. The European Medicines Agency's page for Zypadhera sets the same 3-hour minimum.
PDSS is the reason, a reaction of heavy sedation or delirium that can follow an injection of the older product. Teva's researchers attribute it to an uncontrolled release of olanzapine, and the new depot was designed to prevent one. A Teva laboratory study published in Pharmaceutics in May 2026 reported that the copolymer formed a solid matrix on contact with human plasma. A phase 1 study of 71 patients, published in Clinical Drug Investigation in March 2026, reported no PDSS events.
No case was observed in SOLARIS either, according to the company. A rare event, though, needs a large exposure before its absence means much. Around 600 people treated is a small number for that purpose, which is why the label, as Teva quotes it, still says the risk is not known. The gain Teva claims is practical: no 3-hour wait after each injection, and an injection under the skin rather than into muscle.
A Teva-funded survey of 70 trial participants and 35 clinical staff, published in Advances in Therapy in September 2026, found that 79% of patients preferred the injection under the skin. Respondents were paid an honorarium and the sample was self-selected, so the figure describes attitudes in 1 trial and not demand.
Is Weltruza approved in the UK or EU
No. Teva's 9 October statement says TEV-'749 is not approved by the European Medicines Agency, which accepted the marketing application in May 2026. The company's announcement does not mention a UK application, and no MHRA authorisation for Weltruza was found on 14 October 2026.
A decision by the FDA has no legal effect in Britain or the European Union. Any route into the UK would need its own MHRA licence, and an EU licence would need a positive opinion from the EMA's medicines committee followed by a European Commission decision. Neither has been reported. Until then the product cannot be prescribed in either territory as a licensed medicine.
British patients are also absent from the evidence. None of the 82 SOLARIS sites was in the UK, so any MHRA assessment would rest entirely on results from other populations, in a trial where three quarters of participants were men.
For UK and European readers the existing position is unchanged. Zypadhera, with its 3-hour rule, remains authorised in the European Union, according to the agency's page read on 14 October 2026. Anyone taking an antipsychotic who has questions about switching formulation should speak to the psychiatrist or pharmacist responsible for their care. Suspected side effects of any medicine can be reported to the MHRA through the Yellow Card scheme.
What is still unknown
Several open questions each have a document that will answer them.
The FDA's full prescribing information and review documents, which will show whether reviewers raised concerns about the dropout rate or the size of the placebo response.
A peer-reviewed report of SOLARIS, with the protocol and statistical analysis plan.
The EMA committee's opinion on the application accepted in May 2026.
Whether PDSS appears once many thousands of people have been treated.
Any head-to-head comparison with oral olanzapine or the older injection.
In SOLARIS, Weltruza cut schizophrenia symptom scores by about 10 points more than placebo at 8 weeks, with more weight gain. One manufacturer-funded trial carries that result, and no peer-reviewed paper has followed yet.
Its case rests less on efficacy than on removing a 3-hour supervision rule, and that case depends on PDSS staying absent. This article was written from the registry, PubMed, the FDA and EMA pages and Teva's statement. It will be reviewed by 14 January 2027, or sooner if the FDA label or an EMA opinion is published.
