FDA approves Teva's Weltruza, a once-monthly under-the-skin olanzapine shot for schizophrenia

Teva said on 9 October 2026 that the FDA approved Weltruza (olanzapine) extended-release injectable suspension for adults with schizophrenia.

Key facts

• A once-monthly subcutaneous long-acting injectable (LAI) — the first such olanzapine product, according to Teva.
• No loading doses, no oral supplementation and no post-injection monitoring are required, per the company.
• Three strengths: 318 mg, 425 mg and 531 mg; US launch expected in the coming weeks.
• Based on the Phase 3 SOLARIS trial, which showed improvements on PANSS symptoms, illness severity (CGI-S) and personal and social functioning (PSP), with systemic safety consistent with oral olanzapine.
• It is the second product from Teva’s partnership with French biotech Medincell, after risperidone LAI Uzedy (2023); Medincell may receive up to $112 million in further milestones, CNBC reports.

Why it matters

Missing doses is a major driver of relapse in schizophrenia; long-acting injections aim to address adherence.

Limitations

Trial details here come from Teva’s announcement; full SOLARIS results and long-term real-world data should be reviewed. Olanzapine is associated with metabolic side effects such as weight gain.