Observed each year on May 24, World Schizophrenia Awareness Day shines a light on one of the most misunderstood mental health conditions.
Schizophrenia is a chronic psychiatric disorder that alters how individuals perceive reality, think and relate to others.
Symptoms are typically categorized as positive (hallucinations, delusions), negative (emotional withdrawal, social disconnection) or cognitive (memory or attention deficits).
While current treatments help manage symptoms, many patients experience limited relief or struggle with tolerability — challenges that ongoing research aims to overcome.
According to DelveInsight, schizophrenia affects nearly 1.4 million people in the US and around 3.8 million across seven major global markets. Onset usually occurs in late adolescence or early adulthood, with men often affected earlier than women.
Despite more than 60 approved antipsychotics, approximately 30% to 50% of patients are treatment-resistant, with another 20% to 30% responding only partially.
In Australia, May 18 to 24 is observed as Schizophrenia Awareness Week, spotlighting efforts to improve public understanding and clinical support for those living with the condition.
XTALKS WEBINAR: Get ready for a new wave of clinical trials in Schizophrenia: how Sites and Sponsors can avoid conceptual mistakes
Live and On-Demand: Monday, June 16, 2025, at 11am EDT (4pm BST/UK)
Register for this free webinar to explore how sponsors and CROs can optimize clinical trials in schizophrenia by actively involving investigational sites.
Targeting Agitation, Cognitive Symptoms and Drug-Resistant Schizophrenia
Several research programs are advancing through pivotal stages in the US and internationally, aiming to expand treatment options and improve outcomes.
BioXcel Therapeutics is conducting the Phase III SERENITY At-Home trial of BXCL501, a dissolvable sublingual film of dexmedetomidine for self-administered agitation treatment in schizophrenia and bipolar disorder. The trial is collecting real-world safety data along with usability assessments using modified versions of standard clinical rating tools — the modified Global Impression of Severity (mCGI-S) and Global Impression of Change (mCGI-C) scales. Topline results, expected in late 2025, could support a label expansion of the currently FDA-approved formulation.
Anavex Life Sciences has completed enrollment for its Phase II trial of ANAVEX3-71, a dual SIGMAR1 receptor agonist and M1 muscarinic modulator. The investigational therapy targets positive, negative and cognitive symptoms of schizophrenia, with reduced risk of side effects linked to dopamine-based drugs. Results are expected in the second half of 2025.
Alto Neuroscience is developing ALTO-101, a PDE4 inhibitor delivered through a transdermal patch, to address cognitive impairment associated with schizophrenia (CIAS). The drug enhances theta-band EEG activity, a marker of executive function, and is currently being tested in a Phase II proof-of-concept trial as part of Alto’s biomarker-driven precision psychiatry pipeline.
For those with treatment-resistant schizophrenia (TRS), Newron Pharmaceuticals is advancing the ENIGMA-TRS Phase III program for evenamide, a glutamate modulator. Administered as an add-on to second-generation antipsychotics like clozapine, evenamide is being evaluated in over 1,000 patients across two global studies. Interim results are expected in late 2026.
Related: Cobenfy Approved as First-in-Class Treatment for Schizophrenia
Stigma, Violence and the Need for Nuance
Despite advances in treatment, schizophrenia remains heavily stigmatized — often due to the misconception that individuals with the condition are inherently violent.
While some studies have observed higher aggression among patients with comorbidities such as substance use, the overall risk of violence remains low. A 2021 study found that fewer than one in 20 women and fewer than one in four men with schizophrenia spectrum disorders (SSD) had violent arrests or convictions over a 35-year period.
Research points to external risk factors — including drug use, poverty, social exclusion and housing instability — as stronger contributors to violent behavior than schizophrenia itself.
Yet stigma persists.
In one large-scale study, 64.5% of individuals with schizophrenia reported experiencing social stigma. These experiences can delay recovery, reduce treatment adherence and influence diagnostic decisions.
Clinicians may also carry bias: some research suggests psychiatrists are more likely to suspect violence in patients with schizophrenia than in those with bipolar disorder, potentially leading to skewed diagnoses and management strategies.
Efforts to reduce stigma must prioritize public education, community interaction and equitable access to care.
Market Growth and Who Is Driving Progress
The growing demand for more effective and better-tolerated therapies is expected to drive significant market expansion. DelveInsight projects the global schizophrenia market will grow from $7.9 billion in 2023 to well beyond 2034, supported by the emergence of novel mechanisms, improved diagnostics and an increased focus on cognitive and functional outcomes.
Several late-stage (Phase III) therapies are poised to reshape care over the next decade:
- Ulotaront (SEP-363856), developed by Otsuka and Sumitomo, is a TAAR1 and 5-HT1A receptor agonist that bypasses dopamine D2 pathways entirely.
- Iclepertin (BI 425809) from Boehringer Ingelheim is a selective GlyT1 inhibitor designed to enhance NMDA receptor signaling, targeting cognitive impairment in schizophrenia.
- Brilaroxazine (RP5063) by Reviva Pharmaceuticals modulates serotonin and dopamine receptors, providing multimodal symptom relief.
These therapies, along with Newron Pharmaceuticals’ evenamide discussed above, are expected to deliver Phase III readouts between 2025 and 2026, marking a critical period for schizophrenia drug development.
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