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Caplyta (LUMATEPERONE)
Caplyta works by binding to the 5-hydroxytryptamine receptor 2A, which helps to regulate dopamine and serotonin levels in the brain.
Caplyta (LUMATEPERONE) is a small molecule atypical antipsychotic developed by Intra-Cellular Therapies. It targets the 5-hydroxytryptamine receptor 2A to treat schizophrenia. Caplyta was FDA-approved in 2019 and is currently patented. Key safety considerations include its potential to cause QT interval prolongation and orthostatic hypotension. It has a half-life of 18 hours.
At a glance
| Generic name | LUMATEPERONE |
|---|---|
| Sponsor | Intra-Cellular |
| Drug class | Atypical Antipsychotic [EPC] |
| Target | 5-hydroxytryptamine receptor 2A |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2019 |
| Annual revenue | 900 |
Mechanism of action
The mechanism of action of lumateperone in the treatment of schizophrenia and depressive episodes associated with bipolar or II disorder is unknown. However, the efficacy of lumateperone could be mediated through combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.
Approved indications
- Schizophrenia
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. CAPLYTA 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 behaviors 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) ]. The safety and effectiveness of CAPLYTA have not been established in pediatric patients [see Use in Specific Populations (8.4) ]. 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. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 ) Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients. Closely monitor all antidepressant-treated patients for worsening and emergence of suicidal thoughts and behaviors. Safety and effectiveness of CAPLYTA have not been established in pediatric patients . ( 5.2 , 8.4 )
Common side effects
- Somnolence/Sedation
- Nausea
- Dry Mouth
- Dizziness
- Creatine Phosphokinase Increased
- Vomiting
- Fatigue
- Hepatic Transaminases Increased
- Decreased Appetite
- Headache
- Diarrhea
- Abdominal Pain
Key clinical trials
- Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder (PHASE1)
- Caplyta in Borderline Personality Disorder (PHASE2)
- Neurocircuitry Mechanisms and Efficacy of Lumateperone as Adjunctive Therapy for Major Depressive Disorder and History of Early Life Abuse (PHASE4)
- Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder (PHASE1)
- An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder (PHASE3)
- Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression (PHASE3)
- Study of a Novel Antipsychotic ITI-007 in Schizophrenia (PHASE2)
- A Trial to Assess the Antipsychotic Efficacy of ITI-007 (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Caplyta CI brief — competitive landscape report
- Caplyta updates RSS · CI watch RSS
- Intra-Cellular portfolio CI