FDA approves Teva's once-monthly subcutaneous olanzapine Weltruza

What changes at the injection visit

Teva says the label calls for no loading dose, no oral supplementation and no post-injection monitoring. The approved strengths are 318 mg, 425 mg and 531 mg, matching 10 mg, 15 mg and 20 mg of daily oral olanzapine. That separates Weltruza from Zyprexa Relprevv, the existing intramuscular olanzapine pamoate injection. Zyprexa Relprevv carries a boxed warning for post-injection delirium/sedation syndrome. Its Risk Evaluation and Mitigation Strategy requires at least three hours of observation at a certified facility after every dose, and patients must be accompanied to their destination afterwards, according to the prescribing information cited by Managed Healthcare Executive.

For patients, that removes a three-hour clinic visit after every injection. Teva set a wholesale acquisition cost of $3,950, according to an investor call on 9 October cited by Managed Healthcare Executive.

Weltruza's label does not declare the risk gone. Its safety information says PDSS has occurred with another extended-release olanzapine given intramuscularly and that it is unknown whether it can occur with the subcutaneous form. The SOLARIS safety analysis found no PDSS events through 56 weeks. Estimates of the older product's risk differ between outlets. Pharmacy Times put PDSS at about 1.4% of patients, while Managed Healthcare Executive, citing the FDA, described it as less than 1%. Christoph Correll, a professor of psychiatry at the Zucker School of Medicine at Hofstra/Northwell, told Healio the pamoate product's risk was about one in 1,100 injections, and that the whole dose could be released in two hours. He said the copolymer in Weltruza releases about 15% over days even if injected into the bloodstream.

Why adherence is the target

About half of patients with schizophrenia do not take their medication as prescribed, and the American Psychiatric Association recommends considering long-acting injectables for patients with poor or unknown adherence. The gap shows in the prescribing data. About 19% of patients on oral antipsychotics for schizophrenia use olanzapine, against fewer than 0.1% of patients on a long-acting injectable who use the intramuscular olanzapine formulation. Pharmacy Times attributed that gap largely to PDSS and the three-hour observation rule. An estimated 2.1 million people in the US are diagnosed with schizophrenia. Teva estimates about 1.5 million receive treatment, and about 20% of those are on oral olanzapine.

Psychiatric Times, in a commentary by Peter Weiden of Stony Brook University, notes a typical 10-year delay between an oral antipsychotic and its first long-acting counterpart, and says olanzapine had been the exception because of the pamoate formulation's safety problem. In a SOLARIS attitudes survey, more than 92% of patients, 87% of nurses and 72% of physicians said they were satisfied or very satisfied with the initiation regimen, monthly schedule and dosing options.

What SOLARIS showed

SOLARIS enrolled 675 adults aged 18 to 64 with schizophrenia in an 8-week randomized, double-blind, placebo-controlled period.

All three doses met the primary endpoint, change in PANSS total score from baseline to week 8. The placebo-adjusted differences were -9.71 points for the high dose and -9.71 points for the low dose. The medium dose showed -11.27 points, with adjusted P < .001 for each comparison. CGI-S and PSP scores also improved significantly against placebo, Teva reported. Teva did not report effect sizes, confidence intervals or P values for those two secondary endpoints in its announcement, HCPLive noted.

Common adverse events were weight gain, somnolence, headache, constipation and injection site reactions. Discontinuations due to common adverse events were 5% on olanzapine LAI and 4% on placebo. In the long-term safety analysis, increased weight was reported in 36% of participants, injection site induration and pain each in 12%, erythema in 10%, and pruritus and somnolence in 7% each. Among 137 participants treated for at least 48 weeks, mean weight gain from baseline was 5.6 kg. Teva called the profile consistent with oral olanzapine. Beyond the 8-week period, SOLARIS ran an open-label safety extension of up to 48 weeks, and patients who had received placebo were re-randomized to one of the three active doses.

Teva said 4% of patients relapsed during that second period, which ran to roughly a year.

Launch, royalties and Europe

Teva expects Weltruza in US pharmacies in the coming weeks. Medincell says the US launch is planned for the fourth quarter of 2026. Teva ADRs climbed 4.5% in premarket trading on the Friday of the announcement, Investing.com reported. Weltruza is the second FDA-approved medicine built on Medincell's delivery technology, after Uzedy (risperidone) in 2023. Uzedy brought in $77 million in the second quarter of 2026, up 43% from a year earlier, and Teva's innovative medicines division topped $1 billion in quarterly revenue for the first time in the same period, also up 43%. BigGo Finance, citing a September CTech report, said management has indicated the Uzedy and Weltruza combination could reach peak annual sales of $2 billion.

Medincell collects mid- to high-single-digit royalties on worldwide net sales. It can receive up to $112 million in development and commercial milestones, including $4 million on US approval and up to $105 million tied to sales thresholds. Europe is behind. The European Medicines Agency accepted the marketing authorization application in May 2026 and has not approved the product. Neither company has said when the regulator will decide.