Health · Pharma & Biotech · 22 hrs ago
US approves monthly injection for adults with schizophrenia
The FDA approved Weltruza for adults with schizophrenia in the United States.
The drug is a long-acting form of olanzapine, which is also available as a daily pill.
Weltruza is injected under the skin once a month, without extra starting doses or required medical observation after the injection.
The approval was based on a trial involving 675 adults, and Teva said treatment reduced symptoms and improved patients’ personal and social functioning.
Common side effects included weight gain and sleepiness, as well as headache, constipation and injection-site reactions.
The monthly schedule is intended to make ongoing treatment easier, since taking pills every day can make it harder to stay on treatment and may raise the risk of relapse.
US sales are expected to start in the coming weeks, while a European Union application is still under review.
The US Food and Drug Administration approved Weltruza, a long-acting olanzapine injection for adults with schizophrenia.
The drug is injected under the skin once a month, instead of requiring daily tablets.
The approval was based on the phase 3 SOLARIS clinical trial, which included 675 patients.
Teva said the medicine is expected to reach the US market in the coming weeks.
- Who
- The US Food and Drug Administration approved the drug, which Teva makes.
- What
- Weltruza, a monthly olanzapine injection, was approved to treat adults with schizophrenia.
- When
- The article was published on October 13, 2026. The exact date of approval is not stated.
- Where
- The United States.
- Why
- Teva said the monthly injection is intended to address difficulties with following daily treatment.
This story does not have two clearly opposing sides.
The European Medicines Agency accepted an application to register Weltruza.
Vedomosti reported that the FDA had approved Weltruza.
Teva expected Weltruza to become available on the US market.
- Drug
- Weltruza (WELTRUZA)
- Treatment schedule
- One subcutaneous injection per month
- Trial
- Phase 3 SOLARIS; 675 patients aged 18 to 64
- Dosages
- 318 mg, 425 mg and 531 mg
- US prevalence estimate
- About 2.1 million people diagnosed with schizophrenia