FDA Clears Teva’s Once-Monthly WELTRUZA, Offered in Three Strengths

The FDA has approved Teva Pharmaceuticals’ WELTRUZA, an extended-release olanzapine injection given under the skin once a month for adults with schizophrenia.¹ The approval makes WELTRUZA the first monthly subcutaneous long-acting injectable olanzapine for this adult population, according to the company announcement.¹ Teva says the medicine is expected to become available in the United States in the coming weeks, in three strengths: 318 mg, 425 mg, and 531 mg.¹ The announced schedule is monthly, rather than daily, and the listed strengths are the product’s available injectable doses.¹ The approval is for treatment of schizophrenia in adults; the announcement does not describe it as an approval for children or for other conditions.¹

The FDA’s decision rested on the Phase 3 SOLARIS trial, which evaluated WELTRUZA and reported improvement in overall symptoms.¹ The trial also found a marked decrease in illness severity and better personal and social functioning.¹ These findings describe several kinds of reported change: symptoms, severity, and functioning, rather than a single outcome measure.¹ The company reported that the medicine’s systemic safety pattern matched that associated with oral olanzapine.¹ That comparison concerns the reported safety profile; it does not mean the injection and oral medicine are the same formulation or route of administration.¹

The three injection strengths correspond, respectively, to approved daily oral olanzapine doses of 10 mg, 15 mg, and 20 mg.¹ In other words, the lowest listed monthly injection is paired with the lowest of those daily oral doses, while the highest injection strength corresponds to the highest oral dose in the comparison.¹ The middle pairing is 425 mg injected once monthly and 15 mg taken orally each day.¹ These are dose correspondences stated in the announcement, not a claim that the medicines are taken on the same schedule.¹ The product is described as requiring neither a preliminary loading dose nor extra oral medicine, and it does not require monitoring after the injection.¹

In SOLARIS, all three WELTRUZA doses were described as having similar tolerability.¹ The common adverse events reported included weight increase, sleepiness, headache, constipation, and reactions where the injection was given.¹ Weight gain and metabolic changes were also observed, and the company said these findings fit the systemic safety pattern of oral olanzapine.¹ The reported weight effects included clinically significant weight gain, making weight and metabolic changes part of the safety information relevant to treatment.¹ The announcement does not give rates for each of these individual effects, so their mention does not establish how often each occurred.¹

The share of trial participants who stopped WELTRUZA because of common adverse events was reported as 5%, compared with 4% for placebo.¹ Those percentages refer to discontinuation attributed to common adverse events, rather than to every reason a participant might leave the trial.¹ The difference between the reported figures is one percentage point, with the WELTRUZA figure higher.¹ The figures provide a comparison with placebo for this specific trial outcome, but the announcement does not supply participant counts alongside them.¹ They should therefore be read as reported trial proportions, not as a measure of the total number of people who might discontinue treatment in routine use.¹

The product uses SteadyTeq, a copolymer technology owned by Medincell, to release olanzapine in a controlled and sustained way.¹ That technology is the stated means of delivering the medicine over time in the extended-release injection.¹ The announcement estimates that 2.1 million people in the United States currently have a schizophrenia diagnosis.¹ That figure describes people diagnosed in the country, not the number of people who will receive WELTRUZA or who meet any additional treatment criteria.¹ The approved population specified for WELTRUZA is adults with schizophrenia, while the 2.1 million estimate is presented for diagnosed people in the United States overall.¹

The company warns that WELTRUZA can cause serious side effects, including a greater risk of death among elderly people who have psychosis related to dementia.¹ It is not intended to treat people with dementia-related psychosis.¹ The warning concerns that population and condition, which are distinct from the stated approval for adults with schizophrenia.¹ The announcement also describes post-injection delirium or sedation syndrome, a serious event that can occur if too much olanzapine reaches the bloodstream too quickly.¹ It says this syndrome has occurred with a different extended-release olanzapine medicine administered into muscle; it does not state that it occurred with WELTRUZA.¹

Beyond the U.S. approval, the European Medicines Agency accepted an application in May 2026 seeking authorization for the long-acting olanzapine product TEV-'749 for adults with schizophrenia.¹ Acceptance of that application is a procedural step and is not an EMA authorization.¹ The announcement states that TEV-'749 has not been approved by the EMA at this time.¹ This European regulatory update is separate from the FDA decision on WELTRUZA in the United States.¹ The facts given establish an accepted European application and the absence of EMA approval, without stating a decision date or outcome.¹

Teva scheduled an investor call and live webcast for 8:00 a.m. ET on Friday, October 9, 2026.¹ The announcement identifies that event as an investor call and webcast, rather than as part of the FDA’s approval process.¹ Taken together, the U.S. action authorizes WELTRUZA as a monthly injection for adults with schizophrenia, while the European application remains unapproved.¹ The evidence described for the U.S. decision comes from SOLARIS and includes reported symptom, severity, functioning, and safety findings.¹ The announcement also gives dose pairings, trial discontinuation figures, common adverse events, and important safety warnings, each addressing a different aspect of the medicine’s use.¹