Schizophrenia is a chronic, severe disorder that affects more than 20 millions people worldwide. The disorder is associated with considerable functional impairment as it has the potential to impact all aspects of a patient's life. Patients with schizophrenia may not only experience delusions and hallucinations, but they may also experience limited speech, social withdrawal, disorganized behavior, and more. While an estimated one out of every three people with schizophrenia achieve sustained recovery (based on World Health Organization [WHO] estimates), that still leaves millions dealing with the side effects of the disorder.
Nearly two years ago, we featured schizophrenia in a real-time look at the (at the time) current guidelines and FDA approvals. A lot has changed since then. Today, we are taking a look at the latest regarding schizophrenia in relation to clinical guidance, FDA approvals, and clinical trials since our previous 2024 article.
Current Schizophrenia Guidelines
- INTEGRATE: International Guidelines for the Algorithmic Treatment of Schizophrenia
- Consensus and Physician Experts
- March 2025
- Management of First-Episode Psychosis and Schizophrenia
- Veterans Health Administration (VA) / Department of Defense (DoD)
- May 2023
- Assessment of Cognitive Impairment in Schizophrenia
- European Psychiatric Association (EPA)
- August 2022
- Treatment of Cognitive Impairment in Schizophrenia
- European Psychiatric Association (EPA)
- August 2022
- Treatment of Patients With Schizophrenia
- American Psychiatric Association (APA)
- August 2020
- Pharmacological Treatment of Schizophrenia
- British Association for Psychopharmacology (BAP)
- December 2019
- Schizophrenia
- Neuroscience Education Institute
- June 2013
Recent FDA Approvals for Schizophrenia
Below are the medications and therapies recently approved (since our 2024 article) by the FDA that we anticipate being incorporated into future clinical guidelines:
- Lumateperone (Caplyta)
- Janssen
- April 2026
- Approved for the prevention of relapse in schizophrenia.
- Milsaperidone (Bysanti)
- Vanda Pharmaceuticals
- February 2026
- For the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults.
- Aripiprazole (Mezofy)
- CMG Pharmaceuticals
- April 2025
- For the treatment of schizophrenia in adult and pediatric patients ages 13 years and older.
- Xanomeline and Trospium Chloride (Cobenfy)
- Bristol Myers Squibb
- September 2024
- For oral use for the treatment of schizophrenia in adults.
- Paliperidone Palmitate (Erzofri)
- Luye Pharma
- July 2024
- For treating schizophrenia in adults and treating schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.
Ongoing Clinical Trials Related to Schizophrenia
The following are ongoing, Phase 3 clinical trials based in the United States that we anticipate may impact future schizophrenia clinical guidelines.
- Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications
- Minerva Neurosciences
- Anticipated Primary Completion: December 2027
- A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively
- Karuna Therapeutics
- Anticipated Primary Completion: March 2030
- Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia (NOVA2)
- LB Pharmaceuticals
- Anticipated Primary Completion: June 2027
Check out our other psychiatry-related content and be sure to sign up for alerts to keep up with the latest guidelines and insights.