3 Psychiatry Headlines You Missed in July 2026

Psychiatry saw significant movement in July 2026 across drug approvals and late-stage trial data. The US Food & Drug Administration (FDA) approved centanafadine (SIMTRIYO), the first-in-class NDSRI for ADHD in adults and children aged ≥ 6 years, offering clinicians a new mechanism of action distinct from existing stimulant and nonstimulant therapies.

Psychedelic-assisted treatments for depression also advanced on 2 fronts. John Sonnenberg, PhD, detailed the design of the phase 3 EMERGE trial evaluating DT120 (lysergide) ODT in major depressive disorder (MDD), which met its primary endpoint with durable symptom improvement through week 12. Separately, Boadie Dunlop, MD, MSC, discussed new 26-week data from Compass Pathways' COMP006 trial, showing sustained benefit and meaningful remission rates following retreatment with COMP360 psilocybin in treatment-resistant depression (TRD).

These updates reflect continued diversification in psychiatric treatment options, from novel small-molecule mechanisms to next-generation psychedelic therapies moving closer to potential FDA submission.

FDA Approves Centanafadine for ADHD in Adults, Children Aged ≥ 6 Years

The FDA approved centanafadine (SIMTRIYO) on July 24, 2026, for ADHD in adults and pediatric patients aged ≥ 6 years weighing ≥ 20 kg. Developed by Otsuka Pharmaceutical, centanafadine is the first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) approved for ADHD, offering a mechanism distinct from existing stimulant and nonstimulant therapies. The once-daily extended-release capsule is expected to reach the market later in 2026, pending DEA scheduling.

Approval was supported by 4 phase 3 trials across children, adolescents, and adults, showing statistically significant symptom improvements versus placebo, with benefits emerging as early as week 1. A phase 3b study in adults with comorbid anxiety also showed positive results, with full data forthcoming.

The drug carries boxed warnings for suicidal ideation in patients aged 6 to 12 years and for abuse/misuse potential as a CNS stimulant. Common adverse effects included decreased appetite, nausea, headache, and insomnia. Experts say the approval expands individualized treatment options for the estimated 22.5 million Americans living with ADHD.

Sonnenberg Breaks Down EMERGE Phase 3 Trial Design for DT120 in MDD

John Sonnenberg, PhD, of the Uptown Research Institute and Northwestern's Feinberg School of Medicine, discussed the design of EMERGE, a phase 3 trial evaluating DT120 (lysergide) ODT 100 µg for MDD. The multicenter, randomized, placebo-controlled trial enrolled 149 adults with non-treatment-resistant MDD and met its primary endpoint, showing a placebo-adjusted MADRS reduction of 8.1 points at week 6, sustained through week 12, with a 24% remission rate versus 3% for placebo and no serious safety signals.

Sonnenberg detailed strict inclusion criteria excluding treatment-resistant patients and those with significant prior psychedelic exposure, a rigorous month-long screening process involving independent raters, and dosing sessions monitored by two dosing session monitors. Patients returned weekly for MADRS assessments through week 12 before entering an open-label extension, which tracked outcomes and eligibility for redosing over a year. Sonnenberg emphasized that patients often reported an altered relationship to residual symptoms rather than complete symptom resolution, distinguishing psychedelic treatment from conventional psychiatric approaches.

Related: Emerge Phase 3: DT120 Shows Rapid, Durable Relief in MDD.

What New 26-Week COMP006 Data Mean for TRD, With Boadie Dunlop, MD

New 6-month data from Compass Pathways' phase 3 COMP006 trial show that patients with TRD who partially responded to a single dose of COMP360 psilocybin continued improving through week 26, with nearly 30% of week-6 responders reaching remission after a second dose. Investigator Boadie Dunlop, MD, MSC, of the Medical College of Georgia at Augusta University, discussed the findings with HCPLive.

In COMP006, 39% of participants on the 25-mg dose achieved a clinically meaningful MADRS reduction by week 6, a response generally maintained through week 26, though this fell short of remission. Dunlop noted the retreatment benefit remains hard to predict, though a gap of ≥ 6 weeks between doses appeared favorable.

Serious adverse events occurred in similar rates across dose arms (5.7%–6.3%), which Dunlop said supports tolerability in specialized settings, while cautioning that safety monitoring will be critical as treatment expands into general practice. Compass Pathways plans to submit an NDA to the FDA in Q4.

Related:

COMP360 Psilocybin Sustains Depression Benefit Through 26 Weeks

COMP360 Psilocybin for TRD: What to Know Before a Possible 2027 Launch