April in Review: Updates on the Psychiatric Treatment Pipeline

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Take a look at this month’s developments in the psychiatric treatment pipeline. We compiled a recap of the latest news here, just in case you missed any of the updates.

New NDA Submitted: Bysanti to Treat Acute Bipolar I and Schizophrenia

Vanda Pharmaceuticals has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) requesting marketing approval of milsaperidone (Bysanti, also known as VHX-896 and P-88) for the treatment of patients with acute bipolar I disorder and schizophrenia. The NDA is supported by several clinical studies assessing the efficacy and safety of Bysanti. Bysanti is an active metabolite of iloperidone and atypical antipsychotic drug that researchers believe achieves its therapeutic effect by interacting with a host of neurotransmitter receptors in the brain, targeting 5-hydroxytryptamine receptor 2 (HTR2) and D2 dopamine receptor (DRD2). If approved, Bysanti could be available for sale in the US in 2026.

Positive Interim Results on Trontinemab Validate Brainshuttle Technology for Alzheimer Disease Treatment

Roche shared interim trial data for trontinemab to clinically validate its proprietary Brainshuttle technology for the treatment of prodromal or mild to moderate Alzheimer disease (AD). Trontinemab is a reformulation of anti–beta-amyloid antibody gantenerumab, modified with the Brainshuttle platform to bind to transferrin receptors on endothelial cells and cross the blood-brain-barrier. Results from the phase 1B/2A Brainshuttle AD study showed that trontinemab achieved rapid and robust amyloid plaque reduction at low systemic doses. Roche aims to utilize Brainshuttle to deliver higher antibody concentrations to the brain while reducing the risk of amyloid-related imaging abnormalities. The encouraging results prompted Roche to initiate a phase 3 study of trontinemab, expected to begin later this year.

MindMed Begins Phase 3 Emerge Study of MM120 in Patients With Major Depressive Disorder

MindMed announced that the first patient has been dosed in its phase 3 Emerge study evaluating MM120 ODT for treatment of major depressive disorder (MDD). MM120 ODT is a proprietary, pharmaceutically optimized form of lysergic acid diethylamide (LSD). MindMed will also test the efficacy and safety of MM120 ODT 100 µg compared with a placebo, with an expected enrollment of approximately 140 participants in the United States. Previous trials showed MM120's rapid, long-lasting effects and superior efficacy over SSRIs and benzodiazepines for generalized anxiety disorder (GAD).

Cybin Announces Partnership With Osmind to Advance Clinical-Stage Psychiatry Programs

Cybin, a late-stage breakthrough neuropsychiatry company, announced a strategic partnership with Osmind, a leading service provider advancing psychiatry through technology, services, and real-world evidence. Cybin is currently developing 2 main potential treatments: CYB003, a deuterated psilocybin molecule, in phase 3 development for the adjunctive treatment of MDD, and CYB004, a proprietary deuterated N, N-dimethyltryptamine program in a phase 2 study for GAD.

Cobenfy as Add-On Treatment for Schizophrenia Fails to Meet Primary Endpoint in Phase 3 ARISE Trial

According to topline results from the phase 3 ARISE study, xanomeline and trospium chloride (Cobenfy) as an adjunctive treatment to atypical antipsychotics did not show a statistically significant difference compared with placebo in adults with inadequately controlled symptoms of schizophrenia. Despite not meeting the primary endpoint, Cobenfy's safety profile and potential benefits suggest further investigation is warranted.

Transneural Therapeutics: A New Company to Develop Novel Neuroplastogens

Transneural Therapeutics, a new preclinical-stage biotechnology company, announced its launch on April 22, 2025. Transneural aims to transform the treatment of neuropsychiatric and neurodegenerative diseases with novel neuroplastogens, in particular recognizing the potential of 5-HT2A agonism to treat these conditions. The company's lead asset is TN-001, a dual 5-HT2A partial agonist/5-HT2B antagonist with serotonergic receptor engagement created to deliver rapid and enduring antidepressant effects that rival psychedelic treatment without the risk of hallucinations or dissociative adverse effects. Its lack of adverse effects could potentially eliminate the need for clinical supervision and offer the possibility of traditional dosing. TN-001 is currently in preclinical development for MDD and posttraumatic stress disorder.

First-of-its-Kind Study: Using a Novel Platform to Assess Patients With Borderline Personality Disorder

Boehringer Ingelheim, the University of Oxford, and Cumulus Neuroscience are teaming up for a first-of-its-kind study that will use the novel NeuLogiq neuroassessment platform to quantify brain activity, mood, and behavior at home in individuals who have been diagnosed with borderline personality disorder (BPD). Investigators will recruit 30 young adult participants who have been diagnosed with BPD and 20 young adult participants with no diagnosed mental health disorder, all aged 18 to 35. Participants use a tablet to perform gamified versions of established objective behavioral tasks while wearing the NeuLogiq headset, which records EEG brain waves that are precisely time-synced to the tasks. Investigators thus capture data that will provide a more accurate picture of brain network activity.

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