Drug Watch

New phase 3 data highlights seltorexant's potential as a safer adjunctive treatment for major depressive disorder with insomnia, despite not meeting primary end points. Andrew J. Cutler, MD, shares his thoughts.

INmune Bio reveals phase 2 trial results for XPro1595, a novel treatment targeting neuroinflammation in early Alzheimer disease.

Anebulo Pharmaceuticals initiates a phase 1 trial for selonabant, targeting acute cannabis toxicity in children with promising IV treatment potential.

A new study reveals tasimelteon (Hetlioz) significantly improves sleep onset in chronic insomnia patients.

Synendos Therapeutics reveals promising phase 1 results for SYT-510, a novel ECS modulator targeting anxiety and CNS disorders with potential for improved patient outcomes.

A phase 2 study reveals osavampator significantly reduces depression severity in adults with major depressive disorder, showing promise for treatment-resistant cases.

New analysis reveals Ingrezza achieves rapid symptomatic remission in tardive dyskinesia, enhancing patient quality of life and reducing disease burden.

New phase 2a study reveals promising results for BPL-003, with a 2-dose regimen improving outcomes for patients with treatment-resistant depression.

New phase 3 data reveals seltorexant's potential as a safer adjunctive treatment for major depressive disorder with insomnia, despite not meeting its primary end point.

Esketamine nasal spray shows significant improvement in emotional blunting for treatment-resistant depression, offering hope for affected patients.

Adial Pharmaceuticals has received feedback from FDA on the AD04 phase 3 adaptive clinical trial design and broader clinical development strategy.

New research reveals ART12.11, a cannabidiol:tetramethylpyrazine cocrystal, significantly enhances mood regulation, outperforming traditional cannabidiol in treating mood and anxiety disorders.

Alto Neuroscience reveals EEG biomarkers effectively distinguish patients with schizophrenia, enhancing treatment precision and advancing psychiatric research.

Tonmya, the first new FDA-approved fibromyalgia treatment in 15 years, shows promise in reducing pain and improving patient outcomes according to newly released data.

FDA approves Amneal Pharmaceuticals' new long-acting injectable risperidone for schizophrenia, enhancing treatment options and potentially patient adherence.

Alixorexton shows promise as a treatment for narcolepsy type 1, and is the first orexin 2 receptor agonist to demonstrate clinically meaningful and statistically significant impact on wakefulness, cognition, and fatigue with once-daily dosing across a range of doses.

Cognition Therapeutics advances zervimesine phase 2 trial, exploring its potential to slow cognitive decline in Alzheimer disease patients.

Neuphoria Therapeutics announces successful enrollment in a pivotal trial for BNC-210, a promising treatment for social anxiety disorder.

Achieve Life Sciences gains FDA acceptance for cytisinicline, a promising new drug for smoking cessation, showing significant abstinence rates in trials.

The FDA has approved the Leqembi subcutaneous autoinjector for at-home Alzheimer disease treatment.

Check out the pipeline updates from August!

NRX-100, a preservative-free ketamine, is granted expanded access for treatment of suicidal ideation in depression, offering new hope for patients.

BioXcel Therapeutics reveals promising phase 3 results from the SERENITY trial, paving the way for potential at-home treatment of agitation in bipolar disorder and schizophrenia.

Incannex Healthcare shared positive data from its phase 2 clinical trial of PSX-001, a psilocybin-assisted psychotherapy treatment for generalized anxiety disorder.

Leqembi for the treatment of Alzheimer disease has been launched in Austria on August 25, 2025, and will be launched in Germany on September 1, 2025—the first launches in the EU.