New mechanisms reach the market
STUDY: Tan W, Pharmaceut Med 2026
STUDY TYPE: Report on posters and presentations at APA meting (most trials have not been peer reviewed or published)
FUNDING: Review is independent; the trials are industry-funded
Background
This report in Pharmaceutical Medicine summarized five drug updates from the May 2026 American Psychiatric Association meeting.
ADHD
Centanafadine (Simtriyo) for ADHD. This first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor won FDA approval in July 2026 for patients 6 and older. In two pooled pediatric trials (898 youth), the high dose lowered the ADHD scale (ADHD-RS-5) 5 points more than placebo over 6 weeks; the low dose failed. A separate trial in adults with ADHD and anxiety found it improved both symptoms. More coverage here.
Schizophrenia
Lumateperone (Caplyta) for relapse prevention. Adults with stable schizophrenia who responded to 18 weeks of open-label lumateperone 42 mg were randomized to stay on it or switch to placebo for 26 weeks. Lumateperone lowered relapse risk by 63% (NNT 5), with no change in weight, prolactin, or movement side effects.
Olanzapine-samidorphan (Lybalvi) for negative symptoms. A post hoc analysis of a 4-week trial and its 52-week open-label extension found steady gains on a Negative Symptom scale (Marder factor) through 56 weeks. In clinical records, hospitalizations fell in the 6 months after patients started it. The study lacked a control group.
A methylated form of amisulpride (LB-102) for acute schizophrenia. Amisulpride is one of the most effective antipsychotics for schizophrenia, but is not available in the US. It blocks D2, D3, and 5-HT7 receptors. In a 4-week phase 2 trial, scores on the schizophrenia scale (PANSS) fell about 14 points on 50 or 75 mg versus 9 points on placebo. Weight gain was minimal; a few patients had prolactin-related side effects. Phase 3 results are expected in late 2027.
Dementia
Dextromethorphan-bupropion (Auvelity) for Alzheimer’s agitation. Approved in April 2026, it’s the first non-antipsychotic for this use. It eased agitation on the Agitation scale (CMAI) at 5 weeks. Responders who stayed on it had a 3.6-fold lower risk of relapse than those switched to placebo, with no rise in falls, sedation, or cognitive decline. Learn more about a generic alternative.
—Chris Aiken, MD
Director, Psych Partners
Editor in Chief, Carlat Psychiatry Report
