Psychiatry in 2025 has seen major FDA approvals and clinical advances in treatments for depression, bipolar disorder, ADHD, schizophrenia, and anxiety, transforming care options for patients.
FDA Approvals and Treatments
The FDA cleared BrainsWay Ltd’s Deep TMS system for adolescents aged 15 to 21 years with major depressive disorder on November 13, 2025. The noninvasive device delivers daily 20-minute sessions over 4 to 6 weeks, demonstrating significant reductions in depressive symptoms and comorbid anxiety, supported by extensive real-world data.
On October 10, 2025, the FDA approved Teva Pharmaceuticals’ UZEDY, a once-monthly subcutaneous extended-release risperidone using SteadyTeq technology, for adults with bipolar I disorder. The approval provides a controlled drug release option for maintenance therapy.
The FDA initiated a label change for acetaminophen citing evidence linking prenatal use to increased autism and ADHD risk, while collaborating with GSK on approving leucovorin (Wellcovorin) for cerebral folate deficiency to enhance safety awareness and expand treatment options for neurological conditions.
On February 24, 2025, the FDA approved expanded use of Indivior’s SUBLOCADE, a buprenorphine extended-release injection for opioid use disorder, adding thigh, buttock, and upper arm injection sites. The approval reduced induction to a single dose with one-hour observation, improving adherence and supporting flexible, patient-centered treatment.
On January 21, 2025, the FDA approved Johnson & Johnson’s esketamine (SPRAVATO) nasal spray as the first monotherapy for adults with treatment-resistant depression. Phase 4 trials demonstrated rapid, superior improvement in MADRS scores within 4 weeks.
Clinical Trial Advances
Teva Pharmaceuticals submitted a New Drug Application for TEV-749, a once-monthly subcutaneous olanzapine extended-release injection for adult schizophrenia. Phase 3 SOLARIS trial data demonstrated efficacy, safety, and high satisfaction among patients, nurses, and physicians.
Otsuka Pharmaceuticals submitted an application for centanafadine, a novel NDSRI, for ADHD in patients aged 4 to 55 years. Four phase 3 trials showed significant, clinically meaningful improvements with once-daily extended-release centanafadine.
Johnson & Johnson submitted a supplemental application for lumateperone (CAPLYTA) to prevent schizophrenia relapse. Phase 3 data showed a 63% reduction in relapse risk, characterized by high serotonin 5-HT2A receptor occupancy and lower dopamine D2 receptor occupancy.
Axsome Therapeutics’ FOCUS Phase 3 trial showed solriamfetol significantly reduced ADHD symptoms in adults, achieving a 45% mean reduction in AISRS scores versus placebo, with improvement observed as early as week 1.
MindMed’s phase 2b trial demonstrated a single 100 micrograms dose of MM120 (LSD) significantly reduced anxiety in adults with generalized anxiety disorder, with effects sustained through 12 weeks and rapid improvements seen by day 2.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.hcplive.com/view/-psychiatry-in-2025-year-in-review