First Half 2026 Recap – Psychiatry

The first half of 2026 delivered significant regulatory and clinical momentum across psychiatry. The US Food & Drug Administration (FDA) expanded lumateperone (Caplyta) for schizophrenia relapse prevention, approved milsaperidone (Bysanti) for bipolar I disorder and schizophrenia, cleared ProlivRx as the first at-home neuromodulation device for major depressive disorder (MDD), and accepted centanafadine's NDA for priority review in ADHD.

Psychedelic-assisted therapy also gained ground. A White House executive order accelerated federal research pathways, while 3 separate pivotal trials reported positive data. DT120 (lysergide), COMP360 psilocybin, and GH001 each showed rapid, durable antidepressant effects in difficult-to-treat depression.

This half-year recap gathers HCPLive's most notable psychiatry coverage from January through June 2026, spanning new drug approvals, phase 3 trial results, and shifting federal policy on mental health treatment.

FDA Regulatory Roundup: Schizophrenia, Bipolar Disorder, ADHD, and MDD Approvals

FDA Approves Lumateperone sNDA With 63% Relapse Risk Reduction In Schizophrenia

The FDA approved a supplemental New Drug Application for lumateperone (Caplyta, Intra-Cellular Therapies), adding relapse prevention to its schizophrenia indication. Phase 3 Study 304 showed a 63% reduction in relapse risk versus placebo over 26 weeks, with 84% of patients relapse free at 6 months. Christoph U. Correll, MD, of the Zucker School of Medicine at Hofstra/Northwell, said in a statement that relapse often reverses treatment gains and drives hospitalization. Lumateperone is also approved for bipolar depression and adjunctive MDD.

FDA Approves Milsaperidone for Acute Bipolar I Disorder, Schizophrenia

The FDA approved milsaperidone (Bysanti, Vanda Pharmaceuticals), a new atypical antipsychotic and active iloperidone (Fanapt) metabolite, for first-line acute bipolar I mania and adult schizophrenia. Approval leveraged bioequivalence to iloperidone and its existing efficacy database. The drug carries a boxed warning for dementia-related psychosis mortality and requires QTc monitoring, with commercial availability expected in Q3 2026.

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

The FDA approved ProlivRx (Neurolief), the first at-home, physician-directed neuromodulation therapy for MDD unresponsive to antidepressants. The device delivers external combined occipital and trigeminal afferent stimulation (eCOT-AS) through a wearable headset. In the multicenter MOOD trial, led by Linda Carpenter, MD, of Brown University and Butler Hospital, ProlivRx achieved 21.3% remission versus 6.0% for sham.

Related: TMS for MDD Is Changing Fast. Here's What Psychiatrists Need to Know

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

The FDA accepted Otsuka's New Drug Application for centanafadine, a first-in-class norepinephrine-dopamine-serotonin reuptake inhibitor (NDSRI), for priority review in pediatric and adult ADHD, with a July 24, 2026, PDUFA date. Four phase 3 trials showed significant ADHD-RS-5 and AISRS improvements across children, adolescents, and adults versus placebo

Psychedelic Momentum: White House Policy and Phase 3 & 2b Data in Depression

White House Order Accelerates Psychedelic Research for Mental Illness, With Gus Alva, MD

A White House executive order directed the FDA and DEA to accelerate psychedelic drug research for serious mental illness, authorizing national priority vouchers, Right to Try access, and > $50 million in state-level research funding. Gus Alva, MD, medical director of ATP Clinical Research, told HCPLive that patient interest in psychedelics reflects an unmet treatment need rather than a trend to dismiss. Alva cautioned that therapist training and clinical infrastructure must keep pace with expanding federal policy.

Emerge Phase 3 Data Show DT120 Lysergide Delivers Rapid, Durable MDD Relief, Says John Sonnenberg, PhD

Definium Therapeutics' phase 3 Emerge trial showed DT120 (lysergide) ODT produced rapid, durable relief in MDD, meeting its primary endpoint with an 8.1-point placebo-adjusted MADRS improvement at week 6. Remission occurred in 24% of patients versus 3% on placebo, with no suicidality signals. Investigator John Sonnenberg, PhD, of Northwestern University Feinberg School of Medicine, said the results confirmed genuine antidepressant efficacy for psychedelics. A second phase 3 study, Ascend, is underway.

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

Compass Pathways' synthetic psilocybin COMP360 met the primary endpoint in its second phase 3 trial, COMP006, for treatment-resistant depression (TRD). Two 25-mg doses, given 3 weeks apart, produced a statistically significant MADRS reduction versus 1-mg control at week 6. Compass Pathways holds FDA Breakthrough Therapy designation and plans a Q4 2026 NDA submission following rolling review discussions with the FDA.

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

GH Research's phase 2b trial of inhaled GH001 (mebufotenin) showed rapid, durable relief in treatment-resistant depression, with 57.5% remission by day 8 versus 0% on placebo. Michael E. Thase, MD, of the Perelman School of Medicine at the University of Pennsylvania, called the single-day, individualized dosing regimen a wonderful and clinically meaningful result. The short psychoactive duration, 9 to 14 minutes, allows outpatient administration, with retreatment anticipated roughly every 6 weeks.