The US Food and Drug Administration (FDA) has approved once-monthly subcutaneous olanzapine (Weltruza) as a subcutaneous long-acting injectable suspension for treatment of adults with schizophrenia, Teva announced in a press release.
The long-acting formulation does not require loading doses, oral supplementation, or routine post-injection monitoring. Approval was supported by SOLARIS (NCT05693935), a multinational, multicenter, randomized, double-blind, placebo-controlled phase 3 trial evaluating efficacy and safety in adults aged 18 to 64 years with schizophrenia.
During the initial 8-week treatment period, 675 patients were randomly assigned to receive 1 of 3 monthly olanzapine doses (318 mg, 425 mg, or 531 mg) or placebo. The primary end point was change from baseline in Positive and Negative Syndrome Scale (PANSS) total score.
All 3 doses met the primary end point. At week 8, mean differences in PANSS score changes versus placebo were −9.69 points with 318 mg, −11.25 points with 425 mg, and −9.71 points with 531 mg, according to previously reported SOLARIS findings. Improvements in illness severity and personal and social functioning were also reported.
During the placebo-controlled period, weight gain was reported in 35% of olanzapine-treated patients versus 8% receiving placebo. Other commonly reported adverse events included somnolence, headache, constipation, and injection-site reactions. Weight gain and metabolic abnormalities were consistent with the known safety profile of oral olanzapine. Adverse event–related discontinuations occurred in 1% to 3% of patients in both groups.
No cases of post-injection delirium/sedation syndrome (PDSS) were reported during the initial 8 weeks. No suspected or confirmed PDSS cases across 3,470 injections through week 56 were reported. However, the prescribing information states that whether PDSS can occur with olanzapine remains unknown.
Olanzapine carries a boxed warning for increased mortality in older adults with dementia-related psychosis and is not approved for this population. Other clinically important risks include hyperglycemia, dyslipidemia, weight gain, neuroleptic malignant syndrome, tardive dyskinesia, orthostatic hypotension, and drug reaction with eosinophilia and systemic symptoms.
The 3 monthly strengths correspond to oral olanzapine doses of 10 mg, 15 mg, and 20 mg daily, respectively. Teva expects US availability in the coming weeks. The company advises assessing metabolic risk before treatment and monitoring blood glucose and other metabolic parameters during therapy.
Sources
Teva Pharmaceutical Industries Ltd. Teva announces U.S. Food and Drug Administration (FDA) approval of WELTRUZA (olanzapine) for extended-release injectable suspension, as the first and only once-monthly subcutaneous injectable olanzapine for adults with schizophrenia. Published October 9, 2026.
Teva Pharmaceutical Industries Ltd. Teva presents new phase 3 efficacy, safety and tolerability data from SOLARIS trial evaluating TEV-'749 (olanzapine) as a once-monthly subcutaneous long-acting injectable for adult patients diagnosed with schizophrenia. Published 2024.
Teva Pharmaceutical Industries Ltd. New long-term safety data from the completed phase 3 SOLARIS trial support the potential of olanzapine LAI (TEV-'749) as the first long-acting olanzapine treatment option for schizophrenia with no PDSS observed. Published 2025.
ClinicalTrials.gov. Study of olanzapine extended-release injectable suspension in patients with schizophrenia (SOLARIS). NCT05693935.
