Otsuka presents phase 3b results for centanafadine showing improvements in ADHD and anxiety symptoms

Otsuka presents Phase 3b clinical trial results for centanafadine (SIMTRIYO) at Psych Congress 2026, demonstrating consistent, statistically significant improvements in both ADHD and anxiety symptoms among 315 adults with comorbid anxiety disorders. The drug, a first-in-class NDSRI stimulant approved by the FDA for patients aged 6 and older, is currently undergoing DEA scheduling review. While showing efficacy across executive function and global severity scales, its safety profile includes common side effects like nausea and boxed warnings for pediatric suicidal ideation and abuse potential.

Phase 3b centanafadine trial results

• ▪Otsuka presented Phase 3b clinical trial results for centanafadine in adults with ADHD and comorbid anxiety disorders at Psych Congress 2026 on September 21, 2026.
• ▪The Phase 3b clinical trial of centanafadine enrolled 315 adults aged 18 to 65 with attention-deficit/hyperactivity disorder and comorbid generalized anxiety disorder or social anxiety disorder.

ADHD symptom improvement measures

• ▪Centanafadine showed greater improvement than placebo on the Behavior Rating Inventory of Executive Function-Adult Version Global Executive Composite at Week 8, with statistically significant separation starting at Week 1.
• ▪At Week 8, centanafadine demonstrated a statistically significant improvement compared to placebo on the Adult ADHD Investigator Symptom Rating Scale, with a treatment difference of -5.87.

Comorbid anxiety disorder outcomes

• ▪Centanafadine treatment resulted in statistically significant improvements compared to placebo on both clinician-rated and patient-rated global severity measures for anxiety at Week 8.
• ▪Centanafadine demonstrated statistically significant improvements versus placebo in change from baseline on the Hamilton Anxiety Rating Scale total score at Week 8, with a treatment difference of -1.92.

SIMTRIYO FDA approval status

• ▪SIMTRIYO is the first approved norepinephrine, dopamine, serotonin reuptake inhibitor and central nervous system stimulant for attention-deficit/hyperactivity disorder, and is currently under U.S. Drug Enforcement Administration scheduling review.
• ▪The U.S. Food and Drug Administration approved SIMTRIYO, the brand name for centanafadine, for the treatment of attention-deficit/hyperactivity disorder in adults and pediatric patients aged 6 years and older weighing at least 20 kg.

Centanafadine safety profile

• ▪The prescribing information for SIMTRIYO contains boxed warnings for suicidal ideation and behaviors in pediatric patients aged 6 years and older, as well as risks of abuse, misuse, and addiction.
• ▪The most common treatment-emergent adverse events for centanafadine versus placebo in the Phase 3b trial were nausea, decreased appetite, and diarrhea.

Otsuka CNS research portfolio

• ▪Otsuka's presentations at Psych Congress 2026 included clinical development research for ulotaront, an investigational TAAR1/5-HT1A agonist being studied for the treatment of schizophrenia.
• ▪Otsuka presented 26 sponsored abstracts at Psych Congress 2026, which included data characterizing centanafadine's safety, pharmacokinetics, and human abuse potential.

Debatable claims

• ▪Clinicians should avoid prescribing SIMTRIYO to pediatric patients
• ▪The DEA should place strict scheduling restrictions on SIMTRIYO