World Schizophrenia Day 2026: New Data, Tests & Treatment Targets

Investigational drug candidates for the treatment of schizophrenia are in mid- to late-stage development, including a Phase II muscarinic M1/M4 agonist, a PDE10A inhibitor moving toward Phase III and a Phase III glutamate-focused program.

World Schizophrenia Day 2026 will be observed on May 24. The day draws attention to schizophrenia, a serious neuropsychiatric condition that can involve hallucinations, delusions, disordered thinking and cognitive impairment.

Unlike Alzheimer’s disease, which is tied to memory and thinking decline, or Parkinson’s disease, which is more known for movement symptoms, schizophrenia mainly affects how a person perceives reality and functions day to day. 

In the US, about 3.07 million adults were living with schizophrenia spectrum disorders in 2024, according to a JAMA Psychiatry study. Further, data from a 2026 Ontario study found that annual diagnoses of psychotic disorders rose by 60% among young people aged 14 to 20 between 1997 and 2023, while the age of diagnosis declined in more recent birth groups. 

Schizophrenia patients may face delayed diagnosis, difficulty staying on treatment, housing instability and long-term support needs. Like with most neuropsychiatric disorders, caregivers often carry much of the daily burden.

Patients also suffer from anosognosia, meaning they are unaware of their condition. The Schizophrenia & Psychosis Action Alliance estimates that about 50% of patients do not take prescribed medications as directed, often because of anosognosia.

With an added burden of co-occurring medical conditions such as heart disease, liver disease and diabetes contributing to higher premature mortality, patients suffer much more than a gradual decline of their perception. 

Below, we highlight some of the latest updates in schizophrenia research.

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A Blood-Based Test for Schizophrenia and Bipolar I Disorder

A new blood-based test designed to help differentiate schizophrenia from bipolar I disorder in symptomatic patients was recently given FDA Breakthrough Device designation. 

Laguna Diagnostics’ mRNA Gene Biomarker Test uses mRNA biomarker signatures from a venous blood sample to generate a probability score. 

Laguna said the FDA asked it to recheck its main study data using updated analysis methods. In that analysis, the test correctly identified 96.7% of schizophrenia cases, correctly ruled out bipolar I disorder in 100% of cases and had 98.3% overall accuracy.

The test is still under FDA review. If cleared, it could give clinicians a more objective way to support diagnosis, alongside interviews, observation and patient history. 

Schizophrenia Drug Programs Test New Targets

Nxera Pharma’s partner Neurocrine Biosciences dosed the first patient in a Phase II trial of NBI-1117570 in adults with schizophrenia. The investigational oral therapy, NBI-1117570, is a dual muscarinic M1/M4 receptor agonist discovered using Nxera’s NxWave drug discovery platform.

The double-blind, placebo-controlled study is expected to enroll about 120 adults with schizophrenia requiring inpatient treatment. Its primary endpoint is change from baseline in Positive and Negative Syndrome Scale total score, a commonly used measure of schizophrenia symptom severity.

Axsome Therapeutics also added a schizophrenia program in 2026 by acquiring global rights to balipodect, also known as TAK-063, from Takeda. Balipodect is an oral selective phosphodiesterase 10A inhibitor. Axsome plans to begin Phase III trial-enabling activities for schizophrenia in 2026.

Balipodect has completed a 164-patient proof-of-concept Phase II trial in schizophrenia and has been studied in more than 360 people to date.

Treatment-Resistant Schizophrenia: Updates and Setbacks

Last month, Newron Pharmaceuticals said a participant in its evenamide clinical program died suddenly at a study site outside the US, prompting the FDA to pause enrollment of new patients at US sites in ENIGMA-TRS 2.

Newron said the investigator assessed the death as unrelated to treatment, and an independent safety monitoring board recommended that the broader ENIGMA-TRS program continue as planned. 

Evenamide is designed to act on glutamate, one of the brain’s main signaling chemicals. ENIGMA-TRS 1 is continuing globally, with more than 400 patients enrolled.

Amani Therapeutics is taking another approach through AM-01, a fixed-dose combination that includes clozapine and a Phase III-ready novel chemical entity in-licensed from AstraZeneca. Clozapine’s current use is limited by the risk of severe neutropenia and blood-monitoring requirements.

Amani closed a $25 million Series A financing in March 2026 to advance AM-01. The program is intended to preserve clozapine’s efficacy while addressing safety and monitoring barriers that limit its use.