The FDA has approved Weltruza, a once-monthly olanzapine injection for adults with schizophrenia, Teva Pharmaceuticals announced on Oct. 9. It goes under the skin, not into the muscle. For a drug this widely used, that is a bigger change than it sounds.
What Weltruza actually is
Weltruza is an extended-release injectable suspension. In practice, doctors give it once a month. According to Teva, it needs no loading doses, no oral pills on the side, and no monitoring after the shot.
That last point is the headline feature. Teva calls Weltruza the “first and only” once-monthly subcutaneous olanzapine. However, keep in mind that this is Teva’s own marketing claim, not something we could confirm independently.
The drug uses a copolymer technology called SteadyTeq, which belongs to Medincell. As a result, it releases the medicine slowly over the month.
Why a monthly olanzapine injection matters
Teva describes olanzapine as the most widely prescribed atypical antipsychotic for schizophrenia. The pitch for a long-acting version is simple. Daily pills are easy to skip, and skipped doses can set a patient back.
The older long-acting olanzapine shot goes into the muscle. According to Psychiatric Times, it carries a safety program that requires a certified health care facility and three hours of monitoring after each injection. By contrast, Teva markets Weltruza as avoiding that routine.
So here’s the thing. For patients and families, fewer clinic hours and fewer daily decisions could make treatment easier to stick with. That is the promise, anyway.
What the trial showed about this schizophrenia injection
The approval rests on the Phase 3 SOLARIS trial. It randomized 675 patients to low, medium or high doses of the injection, or to placebo. An 8-week phase came first, followed by a 48-week phase.
Teva says patients improved on symptom scores, illness severity and personal and social functioning. Also, a summary of the company’s release reports that stopping treatment because of common side effects was similar for both groups: 5% on Weltruza and 4% on placebo.
Weight gain and metabolic changes were consistent with oral olanzapine, according to that same summary. In other words, the familiar trade-offs are still there.
The warnings patients and doctors should know
The label carries a boxed warning for higher death risk in elderly patients with dementia-related psychosis. It also includes a warning for post-injection delirium sedation syndrome, or PDSS.
Doctors have seen PDSS with the muscle-injected version. Psychiatric Times notes that how often it occurs with the subcutaneous form is unknown. That is exactly the kind of question doctors will be watching as real-world use of this long-acting olanzapine begins.
The business angle for Teva’s olanzapine shot
This is the second FDA-approved product from Teva’s partnership with Medincell. Reuters reported that the first, Uzedy, a long-acting risperidone, was approved in 2023.
Medincell says the approval triggers a $4 million milestone payment, with up to $105 million more in commercial milestones and royalties on sales. Reuters reported Teva shares up about 2% in Tel Aviv on the news. Meanwhile, the broader fight over what Americans pay for drugs keeps heating up, as in the latest drug-price deals with nine more pharmaceutical companies. Elsewhere in the industry, Viatris placed a $1.65 billion bet on non-opioid pain relief.
What to watch next for Weltruza
Teva says Weltruza will be available in the coming weeks in three strengths: 318 mg, 425 mg and 531 mg. The company has not given an exact launch date.
We also don’t have a U.S. price or insurance coverage details yet. Nor is there head-to-head data against other long-acting antipsychotics, so nobody can say yet how it stacks up.
So the real question is not whether a monthly olanzapine shot works. It’s whether the price and coverage make it a practical option for the people who need it.
