Last reviewed 2026-04-20 · How we verify

Latuda (LURASIDONE)

Latuda works by blocking the action of serotonin at the 5-hydroxytryptamine receptor 2A, which helps to regulate mood and reduce symptoms of psychosis.

Latuda (Lurasidone) is a small molecule atypical antipsychotic medication developed by Sunovion Pharms Inc. It targets the 5-hydroxytryptamine receptor 2A to treat bipolar affective disorder, current episode depression, and schizophrenia. Latuda is commercially available as a branded and generic medication, with 19 generic manufacturers. Key safety considerations include the risk of QT interval prolongation and orthostatic hypotension. As a patented medication, its commercial status is subject to change.

At a glance

Mechanism of action

The mechanism of action of lurasidone in the treatment of schizophrenia and other indication is unclear. However, its efficacy in schizophrenia and other indication could be mediated through combination of central dopamine D2 and serotonin Type (5HT2A) receptor antagonism.

Approved indications

• Schizophrenia
• Bipolar Depression (Monotherapy)
• Bipolar Depression (Adjunctive Therapy)

Boxed warnings

• WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Lurasidone hydrochloride is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.2 )]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Lurasidone hydrochloride is not approved for the treatment of patients with dementia-related psychosis ( 5.1 ). Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients. Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors. ( 5.2 ).

Common side effects

• Somnolence
• Akathisia
• Extrapyramidal Symptoms
• Nausea
• Diarrhea
• Vomiting
• Anxiety
• Nasopharyngitis
• Influenza
• Urinary Tract Infection
• Back Pain
• Dry Mouth

Drug interactions

• amprenavir
• aprepitant
• atazanavir
• boceprevir
• carbamazepine
• clarithromycin
• diltiazem
• enzalutamide
• erythromycin
• fluconazole
• fosamprenavir
• fosphenytoin

Key clinical trials

• An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine (PHASE4)
• Sequential Multiple Assignment Randomized Trial for Bipolar Depression (PHASE4)
• A Randomized, Double-Blind Controlled Comparison of NRX-101 vs. Placebo for Adults Being Treated With Transcranial Magnetic Stimulation for Treatment Resistant Depression (PHASE2,PHASE3)
• Maternal And Infant Antipsychotic Study
• A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group
• Sleep Quality, Cognitive Performance, and Computerized Cognitive Training
• Impact of Aripiprazole Once Monthly Medications on Changes in Brain Structure and Metabolism (PHASE4)
• High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia (PHASE4)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Latuda CI brief — competitive landscape report
• Latuda updates RSS · CI watch RSS
• Sunovion Pharms Inc portfolio CI