Weltruza Becomes the First Monthly Under-the-Skin Olanzapine Shot Approved for Adults with Schizophrenia, No Post-Injection Monitoring Needed

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Most of the evidence was low certainty. cottonbro studio | Pexels Share on Twitter Share on Facebook Share on Pocket Adults with schizophrenia who take olanzapine, one of the most widely prescribed antipsychotics, now have a once-a-month injection option that does not require hours of observation after each shot. The FDA approved Weltruza, an extended-release olanzapine given under the skin, Teva Pharmaceuticals announced on Oct. 9.

Teva says the drug requires no loading doses, no oral pills alongside the injection and no post-injection monitoring. The company expects it to reach the U.S. market in the coming weeks in three strengths, 318, 425 and 531 milligrams, which correspond to daily oral doses of 10, 15 and 20 milligrams.

For patients and the families who help manage their care, the change addresses a practical problem. Daily pills are easy to miss, and missed doses raise the risk of relapse, emergency visits, and hospital stays. Teva estimates that about 2.1 million people in the United States are diagnosed with schizophrenia.

A long-acting olanzapine injection already exists. Zyprexa Relprevv, approved in 2009, is injected into muscle and carries a risk of post-injection delirium/sedation syndrome (PDSS), a reaction that can cause heavy sedation or confusion within hours of a dose. Under an FDA safety program, patients receiving it must be monitored at a certified facility for at least three hours after each injection, according to an FDA drug safety communication.

That link to PDSS has considerably limited the older drug’s use, Fierce Pharma reported. Removing the wait could make a monthly injection easier to fit into a clinic schedule, a work shift or a caregiver’s day.

Teva’s chief medical officer, Eric Hughes, said the formulation is designed to “eliminate the need for monitoring after each injection.” Weltruza uses a polymer technology from French partner Medincell that releases olanzapine slowly under the skin.

The approval rests on the phase 3 SOLARIS trial, a randomized, double-blind, placebo-controlled study of 675 adults ages 18 to 64 whose schizophrenia had acutely worsened. For eight weeks, participants received one of three monthly doses or placebo. Those on placebo were then switched to active treatment for up to 48 more weeks.

All three doses improved symptoms more than placebo on the Positive and Negative Syndrome Scale, a standard measure of schizophrenia symptoms. As reported by AJMC, the differences from placebo at week eight were about 9.8 points for the low dose, 11.3 for the middle dose and 9.8 for the high dose. The doses also improved illness-severity and social-functioning scores.

The trial was sponsored by Teva, and those efficacy figures come from a conference poster rather than a peer-reviewed journal article. Christoph Correll, a psychiatrist at the Zucker School of Medicine at Hofstra/Northwell, led the poster and was quoted in Teva’s announcement. He said “adherence continues to be a major barrier to stability,” as HCP Live reported.

Several limits matter. The placebo-controlled phase lasted only eight weeks, and adults over 64 were not enrolled. The trial was not designed to compare Weltruza with daily olanzapine pills or other long-acting injections, so it cannot show that the new shot works better than existing options.

The injection carries the same body-wide risks as olanzapine pills. The most common side effects in SOLARIS were weight gain, sleepiness, headache, constipation, and injection-site reactions, and Teva reported weight and metabolic changes consistent with oral olanzapine, including clinically significant weight gain.

In a longer-term analysis, increased weight was reported in 36% of participants on the injection, and injection-site hardening and pain each occurred in 12%, according to Patient Care. Discontinuations because of common side effects were 5% with Weltruza and 4% with placebo, AJMC reported.

PDSS remains an open question. No suspected or confirmed cases were reported across more than 3,400 injections in the SOLARIS program, but Teva’s safety information says it is not known whether PDSS can occur with Weltruza. Like other antipsychotics, the drug carries a boxed warning about increased risk of death in older adults with dementia-related psychosis, a use for which it is not approved.

Teva did not disclose a price in the approval announcements reviewed. Long-acting injectables are often billed through a clinic or medical benefit rather than a retail pharmacy, so patients may want to ask early about prior authorization, copays and where the shot will be given.

Patients who are stable on daily olanzapine should not stop or switch medication on their own. A psychiatrist can weigh whether a monthly injection fits, including weight, blood sugar and cholesterol history, since olanzapine can raise all three. Regular checks of weight, glucose and lipids are worth discussing before and after any switch.

Caregivers may also want to ask practical questions at the first visit, including who will give the injection, how a missed monthly appointment is handled, and whether transportation or telehealth follow-up is available between shots. Community mental health centers and Medicaid plans may help cover visits for eligible patients.

Families should seek urgent care if a person becomes extremely drowsy, confused, or hard to wake after any injection. Anyone in a mental health crisis can call or text 988 for immediate support.

The drug remains under review in Europe, where the European Medicines Agency accepted Teva’s application in May 2026. In the United States, the next milestones are commercial availability and real-world safety reporting as more patients begin treatment.

Weltruza is a once-monthly extended-release olanzapine injection given under the skin for adults with schizophrenia. It comes in 318, 425, and 531 milligram doses that correspond to daily oral doses of 10, 15, and 20 milligrams.

What makes it different from the older olanzapine shot?

Weltruza does not require loading doses, oral supplementation or post-injection monitoring. The older intramuscular version, Zyprexa Relprevv, requires at least three hours of observation at a certified facility after each dose.

In the phase 3 SOLARIS trial of 675 adults, all three doses improved symptom scores more than placebo after eight weeks. The trial did not compare Weltruza with other treatments.

Common side effects include weight gain, sleepiness, headache, constipation, and injection-site reactions. Olanzapine can also raise blood sugar and cholesterol.

Is post-injection delirium/sedation syndrome still possible?

No cases were reported in the SOLARIS program, but Teva says it is not known whether PDSS can occur with Weltruza. Families should seek urgent care for extreme drowsiness or confusion after an injection.

Teva expects Weltruza to be available in the United States in the coming weeks. Pricing had not been disclosed in the announcements reviewed.