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Jump to Key Points This digest highlights FDA activity in October related to therapeutics for psychiatric illness. For information on approvals in other specialties during 2026, see our FDA Drug Approvals page.
Schizophrenia Drug Now in Monthly Injection
Olanzapine extended-release injectable suspension (Weltruza, Teva Pharmaceuticals) received approval as the first once-monthly subcutaneous long-acting injectable for adults with schizophrenia. The injection requires no loading doses, oral supplementation, or post-injection monitoring, the company said. The approval was based on positive results of the phase 3 SOLARIS trial, where patients showed overall symptom improvement with monthly doses of the injection. Weight gain and metabolic changes were consistent with oral olanzapine.
First Authorized Treatment for Negative Schizophrenia Symptoms
The prescription digital therapeutic Motivista (CT-155, Click Therapeutics, Inc.) received 510(k) clearance as an adjunctive treatment for negative symptoms of schizophrenia in adults. The app, which is meant to be delivered alongside clinical outpatient care, is the first treatment authorized specifically for these symptoms, the company said. The clearance was supported by data from a phase 3 study that showed patients who used Motivista experienced greater improvements in negative symptoms, such as anhedonia and social withdrawal, than those using a digital control app.
FDA Seeks Input on Psychedelic Trial Design
The FDA issued a request for information on how to design early-phase clinical trials of the psychedelic ibogaine. The agency is seeking comments and data on drug dose selection and escalation, as well as safety monitoring and oversight. The US Department of Health and Human Services is prioritizing therapeutics for adults with opioid use disorder and posttraumatic stress disorder for federally supported research.
- Olanzapine ER SC approved: first once-monthly LAI for adult schizophrenia.
- No loading dose, oral overlap, or post-injection monitoring required.
- SOLARIS phase 3: monthly dosing improved overall schizophrenia symptoms.
- Weight gain, metabolic effects similar to oral olanzapine.
- Motivista (CT-155) cleared for negative schizophrenia symptoms adjunctively.
- Phase 3 data: improved anhedonia, social withdrawal vs digital control app.
- FDA requested ibogaine trial-design input: dose escalation, safety monitoring, oversight.
- Evenamide US phase 3 enrollment remains on hold after FDA arrhythmic safety concern.
Treatment-Resistant Schizophrenia Trial Hold Stays
A phase 3 study of evenamide (Newron Pharmaceuticals S.p.A.) for treatment-resistant schizophrenia remains under an FDA clinical hold on enrollment at US study sites. The FDA feedback cited four deaths across all clinical studies of evenamide, compared to one death with placebo, a potential safety signal because the possibility of a fatal arrhythmic mechanism could not be definitively excluded. The study investigators considered three of the deaths unrelated to evenamide and one possibly related as two autopsies were inconclusive. The company said they are reviewing the FDA’s feedback and safety data from the evenamide development program.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
