Drug Watch

The FDA's removal of clozapine REMS enhances access to treatment, while new educational initiatives empower clinicians to improve patient care.

Check out the pipeline updates from May!

Cariprazine shows promise as a long-term adjunctive treatment for anhedonia in major depressive disorder, according to new poster data presented at the ASCP Annual Meeting.

Neurocrine Biosciences reveals promising phase 2 results for NBI-1117568, a novel treatment for schizophrenia, showing significant symptom improvement over placebo.

Promising results from a phase 2 study of CPL'36, a novel PDE10A inhibitor, for acute schizophrenia exacerbation was presented at the APA annual meeting.

New analyses reveal valbenazine (Ingrezza) significantly enhances quality of life and functional outcomes for patients with tardive dyskinesia, supporting its long-term efficacy.

Newron Pharmaceuticals launches pivotal ENIGMA-TRS trials for evenamide, targeting treatment-resistant schizophrenia with promising efficacy and safety outcomes.

Adial Pharmaceuticals advances its treatment for alcohol use disorder, AD04, with FDA meetings and promising genetic insights for targeted therapy.

NRx Pharmaceuticals secures FDA fee waiver for NRX-100, a preservative-free ketamine aimed at treating suicidal depression, enhancing accessibility for patients.

Check out the pipeline updates from April!

A groundbreaking study explores innovative neuroassessment technology to enhance understanding and treatment of borderline personality disorder symptoms.

Transneural Therapeutics launches innovative neuroplastogens to revolutionize treatment for neuropsychiatric diseases, promising safer, effective alternatives to psychedelics.

Cobenfy as an adjunctive treatment to atypical antipsychotics did not reach the primary endpoint of the phase 3 ARISE trial, or a statistically significant difference compared with placebo with an atypical antipsychotic.

Cybin partners with Osmind to enhance mental health treatment access, focusing on innovative therapies for depression and anxiety disorders.

The first patient has been dosed in MindMed’s phase 3 Emerge study evaluating the efficacy of MM120 ODT.

Does trontinemab represent the next generation of anti-amyloid monoclonal antibodies thanks to Brainshuttle technology? New research looks encouraging.

Vanda Pharmaceuticals has submitted an NDA for approval of Bysanti for the treatment of acute bipolar I disorder and schizophrenia.

What percentage of 2025 psychiatric pipeline news was positive vs negative? What disease states are most prominently featured in recent research? Learn more in this exclusive article.

LB Pharmaceuticals presented additional positive data from NOVA1 exploring LB-102 in patients with acutely exacerbated schizophrenia, at the 2025 Annual Congress of the Schizophrenia International Research Society.

Spinogenix announced open enrollment for the phase 2 trial of SPG302, the first synaptic regenerative approach to treat schizophrenia with the potential to improve outcomes across all symptom domains.

The FOCUS phase 3 trial of solriamfetol for the treatment of ADHD demonstrated statistically significant improvements in ADHD symptoms and disease severity.

Check out new data from the long-term, open-label KINECT 4 study on Ingrezza capsules for the treatment of tardive dyskinesia.

Alzamend announced a late 2025 initiation for the phase 2 clinical study of AL001, a novel lithium-delivery system for the treatment of patients with major depressive disorder.

In a survey capturing the lived experiences of individuals with schizophrenia on antipsychotic medications, 27% of participants reported that antipsychotics had done “more harm than good.”

Neurocrine Biosciences has initiated a phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of NBI-1140675 for certain neurological and neuropsychiatric conditions, such as tardive dyskinesia.

BLP-003, currently being evaluated for treatment-resistant depression and alcohol use disorder, today announced their global phase 2b clinical trial has completed patient enrollment.

Pipeline drug BHV-7000 failed to meet primary endpoint in a pivotal phase 2/3 trial for bipolar disorder; meanwhile, BHV-1300 sees success in sustained Reductions in Total IgG.

Check out the pipeline updates from February!

Newly shared top-line phase 4 data demonstrates clinically meaningful and sustained effects of Ingrezza capsules on the physical, social, and emotional impacts experienced with tardive dyskinesia.

The FDA has accepted the supplemental New Drug Application for Uzedy extended-release injectable suspension for the maintenance treatment of bipolar I disorder in adults.