Schizophrenia is a severe mental disorder characterized by psychosis and major disturbances in perception, thinking, and behavior, often causing substantial functional impairment across life domains. It is associated with persistent delusions, hallucinations, and disorganized thought or behavior.
Helus Pharma announced publication in Nature Medicine of Phase 2a trial results showing its short-acting psychedelic SPL026 met its primary endpoint with significant reductions in depressive symptoms at two weeks in moderate-to-severe MDD patients. The company also appointed a new SVP of Medical Affairs and is advancing HLP003 (Breakthrough Therapy Designation from FDA) and HLP004 in its pipeline.
Advances in precision mental health research include TMS findings published in Nature Molecular Psychiatry showing targeted brain stimulation can address specific depression and anxiety symptoms, the launch of the three-year GlobalMinds NHS genomic study analyzing 49,000 DNA samples, and the new $1 million Wellcome Prize for Mental Health Science.
The global schizophrenia drugs market is projected to grow from USD 9.1 billion in 2026 to USD 15.8 billion by 2036 at a 5.8% CAGR. Long-acting injectables and second-generation antipsychotics lead the market.
Laguna won FDA Breakthrough Device Designation for a blood-based schizophrenia test, while Neurocrine dosed the first patient in a Phase 2 trial of NBI-1117570.
Eli Lilly has launched two Phase 2 trials for brenipatide (LY3537031): RENEW-Op-1 for opioid use disorder and RENEW-Scz-1 for schizophrenia. Both are randomized, double-blind, placebo-controlled studies that are not yet recruiting as of February 2026.
Evidence on ketogenic diets remains limited for psychiatric disorders and diabetes, while a systematic review in overweight and obese women with PCOS found significant short-term improvements. Experts said more controlled, long-term studies are needed.
Teva said the FDA accepted its New Drug Application for long-acting olanzapine for schizophrenia, with a decision expected later this year. The company also reported Austedo sales of $2.26 billion in 2025 and plans six biosimilar launches in 2026 and 2027.
Neurocrine Biosciences initiated and dosed the first patients in a Phase 2 trial of NBI-1117570 in adults with schizophrenia. Nxera Pharma said it will receive US$22.5 million in milestone payments to be recognised as Q1 FY2026 revenue.
The FDA approved milsaperidone for bipolar I disorder and schizophrenia, while COMP360 psilocybin met its primary endpoint in a second phase 3 trial for treatment-resistant depression. Phase 2a data showed intravenous DMT (SPL026) significantly reduced depressive symptoms in major depressive disorder patients.
A longitudinal study of 460,000 teenagers found that adolescent cannabis use increases the risk of developing bipolar and psychotic disorders by twofold, as well as raising risks for depression and anxiety.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07616999 |
A 20-Year Follow-up of First Episode Psychosis: Longitudinal Effects of Early Treatment Strategies and Relapse |
NOT_YET_RECRUITING | |
| NCT07615426 |
A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia |
RECRUITING | PHASE1 |
| NCT07615075 |
Clinical Trial of an IL-23 Inhibitor for Immune Activation in Clinical Trial of an IL-23 Inhibitor for Immune Activation in People With Schizophrenia |
NOT_YET_RECRUITING | PHASE4 |
| NCT07609953 |
Cognitive Behavioral Therapy Added to Risperidone for Schizophrenia |
COMPLETED | NA |
| NCT07608250 |
Research Sense of Familiarity in Psychotic Patients |
COMPLETED | |
| NCT07604129 |
Transcranial Sonography and Machine Learning for Schizophrenia Identification |
NOT_YET_RECRUITING | |
| NCT07592884 |
Rochester Forensic Assertive Community Treatment Model in Minnesota |
COMPLETED | NA |
| NCT07586150 |
Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN) |
NOT_YET_RECRUITING | NA |
| NCT07585383 |
A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of KR23248 Capsules in Healthy Adult Subjects |
NOT_YET_RECRUITING | PHASE1 |
| NCT07571148 |
Real-world Patient Characteristics, Treatment Patterns, and Healthcare Utilization Among KarXT Users |
ACTIVE_NOT_RECRUITING |
