The first quarter of 2026 brought regulatory approvals, late-stage psychedelic data, and increased use of at-home neuromodulation and artificial intelligence–supported mental health tools that reflected rapid change across psychiatry. US Food & Drug Administration (FDA) decisions expanded treatment options for acute bipolar I disorder, schizophrenia, and major depressive disorder (MDD), alongside progress toward a potential new nonstimulant therapy for ADHD.

Q1 developments emphasized faster-acting therapies, at-home treatment delivery, and technology-driven care innovation. This recap spotlights 7 psychiatry headlines in Q1.

FDA Updates in Psychiatry: New Approvals

FDA Approves Milsaperidone for Acute Bipolar I Disorder, Schizophrenia

The FDA approved Vanda Pharmaceuticals’ milsaperidone (BYSANTI) for the treatment of acute bipolar I disorder and schizophrenia, expanding pharmacologic options for patients experiencing acute psychiatric episodes. Clinical data supporting approval demonstrated significant symptom improvement across key measures, with tolerability findings consistent with expectations for second-generation antipsychotics. The approval adds another mechanism for clinicians managing acute mood and psychotic symptoms.

FDA Approves ProlivRx, First At-Home Neuromodulation Device for MDD

The FDA approved Neurolief’s ProlivRx, the first at-home neuromodulation device for MDD. The decision represents a shift toward decentralized treatment models, allowing patients to receive neuromodulation therapy outside clinic settings. Investigators highlighted potential benefits for access, adherence, and reduced logistical burden, particularly for individuals unable to attend frequent in-office sessions.

FDA Accepts NDA for Priority Review of Centanafadine to Treat Adult, Pediatric ADHD

The FDA accepted the new drug application for centanafadine for adult and pediatric ADHD and granted priority review. Centanafadine, developed by Otsuka, is a triple reuptake inhibitor targeting norepinephrine, dopamine, and serotonin, representing a potential nonstimulant option. The FDA assigned centanafadine a Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2026.

Promising Phase 2 & Phase 3 Data: Rapid-Acting Psychedelic Therapies

COMP360 Psilocybin Meets Primary Endpoint in Second Phase 3 Trial for TRD

The second phase 3 trial of Compass Pathways’ COMP360 psilocybin met its primary endpoint in treatment-resistant depression (TRD), reinforcing prior late-stage findings. Investigators reported that two 25 mg COMP360 doses administered 3 weeks apart produced a statistically significant reduction in depressive symptom severity at week 6 compared with a 1 mg dose control. The findings support the potential role of psychedelic-assisted therapy in patients with limited treatment response.

Related: COMP360 Psilocybin Shows Rapid, Durable Effect in TRD, With Steve Levine, MD

Single-Day GH001 for TRD Shows Rapid Response, With Michael E. Thase, PhD

A Phase 2b trial evaluating inhaled GH001 demonstrated rapid and clinically meaningful antidepressant effects following a single-day individualized dosing session. Michael E. Thase, MD, of the University of Pennsylvania, highlighted the rapid onset and potential scalability of a single-session psychedelic-based intervention compared with multi-session treatment models. The study showed that GH001 could improve depression severity within 1 week.

Intravenous DMT (SPL026) Demonstrates Significant MDD Reduction in Phase 2a Trial

Phase 2a data for SPL026, an intravenous formulation of dimethyltryptamine (DMT), showed significant reductions in depressive symptoms among patients with MDD. The therapy was associated with a rapid onset of action, adding to the growing body of evidence supporting short-duration psychedelic interventions.

SPL026 is a short-acting serotonergic psychedelic that acts primarily as a 5-HT2A receptor agonist. Unlike psilocybin, which can produce psychoactive effects lasting 4 to 6 hours, intravenous DMT has a shorter duration of acute subjective effects, often under 30 minutes.

Helus Pharma stated they will not be advancing the intravenous formulation in its current form but are using the trial insights to develop HLP004, a proprietary novel serotonergic agonist under investigation for generalized anxiety disorder (GAD).

Growing Use of AI in Psychiatry

Your Patient's New Therapist Is an AI. Now What?

Increasing patient use of generative artificial intelligence tools for mental health support sparked discussion around clinical oversight and safety. Experts noted that patients are turning to AI for therapy-like conversations, raising questions about accuracy, crisis management, and appropriate clinician guidance. Although AI may improve access and reduce stigma, clinicians emphasized that these tools should complement, not replace, professional mental health care, particularly for complex or high-risk cases.