Q3 2026 Recap: Psychiatry News and Updates

Psychiatry regulatory and pipeline activity from July through September 2026 centered on new mechanisms and psychedelic therapies. The US Food and Drug Administration (FDA) approved centanafadine (Simtriyo), the first norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI), for ADHD. Resilient Pharmaceuticals resubmitted its MDMA-assisted therapy new drug application (NDA) for PTSD, and Definium Therapeutics' DT120 received a second Breakthrough Therapy designation in major depressive disorder (MDD).

Phase 3 data advanced the psychedelic pipeline, including 26-week COMP006 results for COMP360 psilocybin in treatment-resistant depression (TRD) and positive Voyage results for DT120 in generalized anxiety disorder (GAD). A September FDA public hearing also raised the question of whether the clinical workforce is ready for its first psychedelic approval.

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

On July 24, 2026, the FDA approved once-daily extended-release centanafadine for ADHD in adults and in pediatric patients aged ≥ 6 years who weigh ≥ 20 kg. The approval was based on 4 randomized, placebo-controlled phase 3 trials. In the pediatric trials, improvement on the ADHD Rating Scale-5 appeared by week 1 and lasted through week 6.

The label has boxed warnings for suicidal ideation and behaviors in children aged 6 to 12 years and for abuse, misuse, and addiction. Commercial availability depends on scheduling by the Drug Enforcement Administration (DEA).

MDMA-Assisted Therapy NDA Resubmitted to FDA for PTSD

Resilient Pharmaceuticals, formerly Lykos Therapeutics, resubmitted its NDA for MDMA-assisted therapy in PTSD without running a new phase 3 trial. The Multidisciplinary Association for Psychedelic Studies (MAPS) confirmed the resubmission on August 10, 2026. The FDA's August 2024 complete response letter (CRL) had asked for more data on durability of response, safety characterization, and bias mitigation.

In July 2026, the FDA issued final guidance on clinical investigations of psychedelic drugs, which covers those same areas.

DT120 ODT Receives Second FDA Breakthrough Therapy Designation in MDD

On September 8, 2026, the FDA granted DT120 (lysergide) orally disintegrating tablet (ODT) Breakthrough Therapy designation for MDD. The drug already held the designation for GAD. Definium has not disclosed a submission timeline for either indication.

Voyage: DT120 ODT Reduces Anxiety in Phase 3 GAD Trial

Voyage randomized 214 adults with GAD to a single 100 µg dose of DT120 ODT or placebo. At week 12, scores on the Hamilton Anxiety Rating Scale (HAM-A) fell 5.4 points more with DT120 than with placebo (P < .0001; Cohen's d = 0.81). Response rates were 43% vs 16%, and remission rates were 14% vs 4%.

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

In COMP006, 39% of participants given COMP360 25 mg had a MADRS reduction of ≥ 25% by week 6, and that response was maintained on average through week 26. Among week 6 responders who had not yet remitted, nearly 30% reached remission after a second dose. Boadie Dunlop, MD, MSC, of the Medical College of Georgia at Augusta University, said serious adverse event rates were similar in the 1 mg and 25 mg arms (6.3% vs 5.7%).

Compass Pathways plans to submit an NDA in the fourth quarter of 2026.

Related:

COMP360 Psilocybin Sustains Depression Benefit Through 26 Weeks

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

Phase 3 PARADIGM: HLP003 (Psilocibin-d10) for Adjunctive MDD Use

At Psych Congress 2026, Helus Pharma presented the design of PARADIGM, a phase 3 program for HLP003, a deuterated psilocin analog. Patients with MDD and an inadequate response to antidepressants receive 2 doses given 21 days apart as add-on treatment. The program includes APPROACH (n = 223; enrollment complete), EMBRACE (n = ~ 330), and a 43-week extension, with change in MADRS at day 42 as the primary endpoint.

APPROACH topline data are expected in the fourth quarter of 2026. Helus is targeting a possible NDA in 2028.