With a Friday go-ahead from the FDA, another key piece of Teva’s innovation revamp strategy has fallen into place, further bolstering the drugmaker’s footing in schizophrenia.
The approval comes for Teva’s long-acting formulation of the decades-old atypical antipsychotic olanzapine, which—girded by steady-release technology from partner Medincell—has now been cleared as Weltruza in an injectable formulation that can be given just once a month.
Teva has been pinning big hopes on Weltruza’s approval, and the company appears to be wasting no time getting the new medicine to market, with plans to launch at three separate strengths “in the coming weeks.”
Aside from the adherence benefits that a once-monthly schizophrenia treatment could confer, Weltruza doesn’t require post-injection monitoring, nor do patients receiving the drug need to start with loading doses or deal with oral supplementation, Teva said in an Oct. 9 release.
At present, olanzapine—which was first approved back in 1996—holds the distinction as the most widely prescribed atypical antipsychotic for schizophrenia, where it’s used as a daily oral treatment.
Nevertheless, that daily regimen can make it hard for patients to stick with their medication schedule, leading to “well-documented” adherence challenges and raising the risk of instability and relapse, according to Teva.
“This approval reflects the strength of patient-centric innovation at Teva and what our R&D organization can deliver,” said Eric Hughes, M.D., Ph.D., Teva’s CMO and EVP of global R&D, in a statement. “Weltruza combines proven science and novel formulation innovation to eliminate the need for monitoring after each injection, addressing a significant barrier to treatment and advancing care for people living with schizophrenia.”
Teva estimates that around 2.1 million people are currently diagnosed with schizophrenia in the U.S., noting that the complex mental health condition often requires patients to switch from oral options or between long-acting injectables during their treatment journeys.
The launch specifically incorporates 318-, 425- and 531-mg doses of Weltruza, which map onto the daily dose ranges of oral olanzapine at 10-, 15- and 20-mg, respectively, Teva added. The Weltruza formulation is powered by Medincell’s SteadyTeq, a copolymer technology that helps deliver a controlled steady, sustained release of olanzapine.
Teva cleared the way for its green light with the phase 3 Solaris trial. When that study read out in May 2024, Teva reported that patients all three long-acting olanzapine dosing groups achieved score changes from baseline on the Positive and Negative Syndrome Scale (PANSS) in schizophrenia at week eight, tying the high-, medium- and low-dose groups to differences of -9.71, 11.27 and -9.71 points, respectively.
Focusing on the patient adherence angle, Teva further built out its olanzapine package last March with a survey of patients, nurses and physicians involved in Solaris on their perception of the then-unapproved Weltruza. The results found that more than 92% of patients, 87% of nurses and 72% of physicians said they were either satisfied or very satisfied with the drug overall, including on metrics related to its more convenient dosing parameters.
Apart from the PANSS endpoint, Teva also tied Weltruza to improvements in schizophrenia patients’ personal and social functioning, as well as a reduction in illness severity.
In another key win for the Solaris trial, Teva previously reported that no cases of post-injection delirium/sedation syndrome (PDSS) were observed in its trial. The company did acknowledge PDSS as a potential side effect in its approval notice, while adding the caveat that it “is not known whether PDSS can happen with Weltruza.”
It’s an important distinction given that Eli Lilly actually won approval for its own version of long-acting olanzapine—marketed as Zyprexa Relprevv—back in 2009. But while the drug is still available, having changed hands to Cheplapharm in 2023, ties between that drug and PDSS have blunted its trajectory considerably. PDSS, which can occur within hours of receiving treatment, is associated with symptoms like sedation and delirium.
Teva further pointed out in its approval announcement that all three doses of Weltruza were similarly tolerated in Solaris, with the most common adverse events including increased weight, sleepiness, headache, constipation and injection site reactions. The weight gain and metabolic changes seen were consistent with olanzapine’s known profile, which can lead to “clinically significant” weight gain.
For its part, Teva figures the playing field is more or less wide open for Weltruza, with CEO Richard Francis pointing out in February that there “is no long-acting market for olanzapine,” providing ample opportunity for a successful launch. Francis’ remarks were made in the context of Teva’s other recent schizophrenia approval in Uzedy—a slow-release version of the tried-and-true risperidone that also leverages Medincell’s technology.
Uzedy has “almost doubled the size of the risperidone long-acting market” since its debut, Francis said earlier this year, while admitting that its risperidone product launched into a much more crowded market. Weltruza, on the other hand, should have significantly more commercial real estate to operate within.
For Medincell’s part, the drug delivery specialist is now entitled (PDF) to mid- to high-single digit royalties on global sales of Weltruza. The company is also in line for up to $112 million in development and commercial milestones, which includes a $4 million payment upon FDA approval.
Both Weltruza and the earlier Uzedy are essential pegs in Teva’s Pivot to Growth Strategy, in which the company has successfully implemented a turnaround under CEO Francis, who arrived at generic and innovative drugs hybrid in early 2023. Under the program, Teva is staying true to its generic and biosimilar roots, while also making a deliberate push to round out its innovative medicine bona fides, too.
As Uzedy has continued to grow, reeling in $191 million in 2025 sales at a 63% year-over-year increase, Teva has consistently noted that an approval for long-acting olanzapine will allow it to truly unlock its opportunity in schizophrenia.
Meanwhile, other facets of Teva’s innovation push, such as tardive dyskinesia drug Austedo and migraine prevention med Ajovy, have also helped correct the company’s balance sheet in recent years.