Caplyta (Lumateperone)

Brand Name

Caplyta

Generic Name

Lumateperone

View Brand Information

FDA approval date: February 01, 2020

Classification: Atypical Antipsychotic

Form: Capsule

What is Caplyta (Lumateperone)?

Navigating the complexities of a serious mental health condition like schizophrenia or bipolar depression is a profound challenge, both for the person diagnosed and their loved ones. The journey toward stability often involves finding the right medication, one that effectively manages symptoms without causing disruptive side effects. In the search for better-tolerated treatments, modern psychiatry has evolved, leading to the development of newer medications. One of these important advancements is Caplyta (lumateperone).

Caplyta is a newer-generation prescription medication that belongs to the class of drugs known as atypical antipsychotics. It is a once-daily oral treatment designed to manage the complex symptoms of schizophrenia and the depressive episodes associated with bipolar disorder. What sets Caplyta apart is its unique and targeted mechanism of action, which is thought to provide effective symptom control with a lower risk of certain side effects commonly seen with older antipsychotic medications, such as weight gain and movement disorders. For many, Caplyta represents a sophisticated and hopeful option in their long-term mental health journey.

What does Caplyta do?

Caplyta is approved by the U.S. Food and Drug Administration (FDA) for two specific mental health conditions in adults:

Treatment of schizophrenia: It helps to manage the symptoms of schizophrenia, including “positive” symptoms like hallucinations and delusions, and “negative” symptoms like social withdrawal and lack of motivation.
Treatment of depressive episodes associated with bipolar I or II disorder: It can be used either as a standalone treatment (monotherapy) or as an add-on therapy with lithium or valproate to lift the symptoms of bipolar depression.

Caplyta aims to rebalance brain chemistry, reducing symptoms and improving overall functioning and quality of life. Clinical studies show its effectiveness; trials for schizophrenia and bipolar depression demonstrated statistically significant symptom improvement compared to placebo (Intra-Cellular Therapies, Inc., 2022).

How does Caplyta work?

The symptoms of schizophrenia and bipolar disorder are believed to be linked to an imbalance of key chemical messengers in the brain, particularly dopamine and serotonin. These neurotransmitters are vital for regulating thoughts, mood and perception. Many antipsychotic medications work by blocking the receptors for these chemicals.

Caplyta restores balance by acting on three key pathways: blocking specific serotonin receptors (5-HT2A) for antipsychotic/antidepressant effects; uniquely modulating dopamine receptors (D2) as a “smart volume control” to reduce high dopamine activity without full shutdown, potentially avoiding movement side effects; and indirectly enhancing glutamate, vital for learning and memory.

This multi-targeted mechanism is designed to provide robust symptom relief while having a minimal impact on the pathways that are associated with common side effects like weight gain, elevated cholesterol, and involuntary movements.

Caplyta side effects

While Caplyta is designed to have a favorable side effect profile, it can still cause side effects, and it’s important to be aware of the risks.

The most common side effects include:

Sleepiness or drowsiness
Dizziness
Nausea
Dry mouth

Caplyta and all antipsychotics carry an FDA boxed warning: increased death risk for elderly dementia-related psychosis patients. Caplyta is not approved for this condition.

Other serious but less common risks include:

Neuroleptic Malignant Syndrome (NMS): A rare but life-threatening reaction with symptoms like very high fever, severe muscle stiffness, and confusion.
Tardive Dyskinesia (TD): A condition that can cause uncontrollable, repetitive movements of the face, tongue, or body, which may become permanent.
Metabolic Changes: While the risk is considered low with Caplyta, it can potentially cause changes in blood sugar, cholesterol, and weight.
Orthostatic Hypotension: A sudden drop in blood pressure when standing up, which can cause dizziness or fainting.

You should contact your doctor immediately if you experience a high fever with stiff muscles, uncontrollable body movements, or any thoughts of harming yourself.

Caplyta dosage

Caplyta is an oral capsule that is taken once a day. A key feature of Caplyta is that it does not require a slow “titration” or gradual increase in dose. The treatment starts and stays at the same therapeutic dose, which simplifies the treatment process. It should be taken with food to ensure it is properly absorbed.

Even though Caplyta has a lower risk of metabolic side effects, your doctor will still monitor your weight, blood pressure, diabetes history, and cholesterol. They will also assess you for movement disorders and schedule regular follow-up appointments to discuss your symptoms and any side effects. This ongoing monitoring ensures the medication works safely and effectively.

Does Caplyta have a generic version?

No, there is no generic version of Caplyta (lumateperone) currently available. However, international versions may exist in other markets. As a newer brand-name medication, it is protected by patents that prevent other manufacturers from producing a generic equivalent for several years. Once these patents expire, the FDA may approve generic versions, which could provide more affordable options.

Conclusion

Caplyta represents a significant step forward in the treatment of schizophrenia and bipolar depression, offering a unique and targeted mechanism of action designed to maximize benefits while minimizing some of the most burdensome side effects of older medications. Its ability to effectively manage symptoms with a low impact on metabolic health and movement makes it a valuable option for many adults on their path to recovery.

While it is a powerful tool, it must be used under the careful supervision of a healthcare provider. A strong, open line of communication with your doctor about your progress and any side effects is essential for success. For the right patient, Caplyta can provide a solid foundation for stability, helping them to take control of their condition and move forward with their lives.

References

Intra-Cellular Therapies, Inc. (2022). CAPLYTA® (lumateperone) Prescribing Information. U.S. Food and Drug Administration. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209500s007lbl.pdf
Mayo Clinic. (2024). Lumateperone (Oral Route). Retrieved from https://www.mayoclinic.org/drugs-supplements/lumateperone-oral-route/symptoms/drg-20492823
National Alliance on Mental Illness (NAMI). (n.d.). Lumateperone (Caplyta). Retrieved from https://www.nami.org/About-Mental-Illness/Treatments/Mental-Health-Medications/Types-of-Medication/Lumateperone-Caplyta

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Brand Information

CAPLYTA (lumateperone)

WARNING:INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDALTHOUGHTS 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

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

1INDICATIONS AND USAGE

CAPLYTA is indicated for:

Treatment of schizophrenia in adults
Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate
Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults

2DOSAGE FORMS AND STRENGTHS

CAPLYTA capsules are available in three strengths:

42 mg: Blue cap and opaque white body imprinted with “ITI-007 42 mg”
21 mg: Opaque white cap and body imprinted with “ITI-007 21 mg”
10.5 mg: Opaque light pink cap and body imprinted with “ITI-007 10.5 mg”

3CONTRAINDICATIONS

CAPLYTA is contraindicated in patients with history of hypersensitivity reaction to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.

4ADVERSE REACTIONS

The following adverse reactions are discussed in detail in other sections of the labeling:

Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Suicidal Thoughts and Behaviors
Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-related Psychosis
Neuroleptic Malignant Syndrome
Tardive Dyskinesia
Metabolic Changes
Leukopenia, Neutropenia, and Agranulocytosis
Orthostatic Hypotension and Syncope
Falls
Seizures
Potential for Cognitive and Motor Impairment
Body Temperature Dysregulation
Dysphagia

4.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of CAPLYTA has been evaluated in placebo-controlled clinical trials that included 3575 adult patients with schizophrenia, bipolar depression, or major depressive disorder, exposed to one or more CAPLYTA doses. A total of 852 CAPLYTA-treated patients had at least 6 months of treatment and 108 had at least 1 year of treatment with the 42-mg once daily dosage.

Adverse Reactions in Patients with Schizophrenia

The following adverse reactions are based on the pooled short-term (4- to 6-week), placebo-controlled studies in adult patients with schizophrenia in which CAPLYTA was administered at a dosage of 42 mg once daily (N=406)

There was no single adverse reaction that led to discontinuation that occurred at a rate of >2% in CAPLYTA-treated patients. The most common adverse reactions (incidence of at least 5% of CAPLYTA-treated patients and greater than twice the rate of placebo-treated patients) were somnolence/sedation and dry mouth. Adverse reactions (incidence of at least 2% in CAPLYTA-treated patients and greater than in placebo-treated patients) are shown in Table 2.

¹ Dizziness, dizziness postural
² ALT, AST, “hepatic enzymes” increased, or liver function test abnormal

Adverse Reactions in Patients with Bipolar Depression (CAPLYTA Monotherapy)

The following adverse reactions are based on the pooled short-term (6-week), placebo-controlled monotherapy bipolar depression studies in adult patients treated with CAPLYTA 42 mg once daily (N=372)

There was no single adverse reaction leading to discontinuation that occurred at a rate of >2% in CAPLYTA-treated patients.

The most common adverse reactions (incidence of at least 5% of CAPLYTA-treated patients and greater than twice the rate in placebo-treated patients) were somnolence/sedation, dizziness, nausea, and dry mouth.

Adverse reactions associated with CAPLYTA (incidence of at least 2% in CAPLYTA-treated patients and greater than placebo-treated patients) are shown in Table 3.

¹Dizziness, dizziness postural
²Abdominal discomfort, abdominal pain, abdominal pain upper and lower

Adverse Reactions in Patients with Bipolar Depression (Concomitant Treatment with CAPLYTA and Lithium or Valproate)

The adverse reactions below are based on a 6-week, placebo-controlled adjunctive therapy bipolar depression study in adult patients treated with CAPLYTA 42 mg once daily + lithium or valproate OR placebo + lithium or valproate (N=177)

There was no single adverse reaction leading to discontinuation that occurred at a rate of >2% in patients in the CAPLYTA + lithium or valproate group.

The most common adverse reactions (incidence of at least 5% in patients treated with CAPLYTA + lithium or valproate and greater than twice the rate of patients treated with placebo + lithium or valproate) were somnolence/sedation, dizziness, nausea, and dry mouth.

Adverse reactions associated with CAPLYTA + lithium or valproate (incidence of at least 2% in patients treated with CAPLYTA + lithium or valproate and greater than with patients treated with placebo + lithium or valproate) are shown in Table 4.

¹Dizziness, dizziness postural

Adverse Reactions in Studies for Adjunctive Treatment of Major Depressive Disorder

The following adverse reactions are based on pooled short-term (6-week), placebo-controlled adjunctive therapy MDD studies in adult patients treated with CAPLYTA 42 mg orally once daily and background antidepressant therapy (ADT) or placebo and background ADT (N=483)

There was no single adverse reaction leading to discontinuation that occurred at an incidence of >2% in patients treated with CAPLYTA and background ADT.

The most common adverse reactions (incidence of at least 5% of patients treated with CAPLYTA and background ADT and greater than twice the incidence in patients treated with placebo and background ADT) were dizziness, dry mouth, somnolence/sedation, nausea, fatigue, and diarrhea.

Adverse reactions in the adjunctive therapy MDD studies (incidence of at least 2% of patients treated with CAPLYTA and background ADT and greater than in patients treated with placebo and background ADT) are shown in Table 5.

¹Headache, migraine, tension headache
²Dizziness, postural dizziness

Additional Adverse Reactions

Dystonia: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. Although these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and higher doses of first-generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Extrapyramidal Symptoms: In the short-term, placebo-controlled schizophrenia, bipolar depression, and adjunctive MDD studies, extrapyramidal (EPS) symptom data was objectively collected on the Simpson-Angus Scale (SAS) for EPS (total score ranges from 0 to 40), the Barnes Akathisia Rating Scale (BARS) for akathisia (total score ranges from 0 to 14), and the Abnormal Involuntary Movement Scale (AIMS) for dyskinesia (total score ranges from 0 to 28).

In the 4- to 6-week, placebo-controlled schizophrenia trials, the frequency of EPS-related reported events including akathisia, extrapyramidal disorder, muscle spasms, restlessness, musculoskeletal stiffness, dyskinesia, dystonia, muscle twitching, tardive dyskinesia, tremor, drooling, and involuntary muscle contractions was 6.7% for the CAPLYTA-treated patients and 6.3% for placebo-treated patients. In these trials, the mean changes from baseline for CAPLYTA-treated patients and placebo-treated patients were 0.1 and 0 for the SAS, -0.1 and 0 for the BARS, and 0.1 and 0 for the AIMS, respectively.
In the 6-week, monotherapy bipolar depression trials, the frequency of reported EPS-related reactions including muscle spasms, dyskinesia, extrapyramidal disorder, movement disorder, tremor, restlessness, and akathisia was 1.3% for CAPLYTA-treated patients and 1.1% for placebo-treated patients. In these trials, the mean changes from baseline for CAPLYTA-treated patients and placebo-treated patients were 0 and 0 for the SAS, -0.1 and -0.1 for the BARS, and 0 and 0 for the AIMS, respectively.
In a 6-week, adjunctive therapy bipolar depression trial, the frequency of reported EPS-related reactions, including tremor, muscle spasms, akathisia, extrapyramidal disorder, gait disturbance, and restlessness was 4% for CAPLYTA-treated patients and 2.3% for placebo-treated patients. In the 6-week, monotherapy bipolar depression trials, the mean changes from baseline for CAPLYTA-treated patients and placebo-treated patients were 0 and 0 for the SAS, -0.1 and -0.1 for the BARS, and 0 and 0 for the AIMS, respectively. In this trial, the mean changes from baseline for CAPLYTA-treated patients and placebo-treated patients were 0 and 0 for the SAS, 0 and -0.1 for the BARS, and 0 and 0 for the AIMS, respectively.
In the 6-week, adjunctive MDD trials, the frequency of reported EPS-related adverse reactions (tremor, bradykinesia, muscle spasms, gait disturbance, tongue spasm, muscle tightness and dyskinesia), excluding akathisia and restlessness, was 5% for CAPLYTA-treated patients and 0.8% for placebo-treated patients. The combined incidence of akathisia and restlessness was 1% for CAPLYTA-treated patients and 0.8% for placebo-treated patients. In these trials, the mean changes from baseline for CAPLYTA-treated patients and placebo-treated patients were 0 and 0 for the SAS, 0 and -0.1 for the BARS, and 0 and 0 for the AIMS, respectively.

4.2Postmarketing Experience

The following adverse reaction has been identified during post-approval use of CAPLYTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.

Central and Peripheral Nervous System Disorders: burning sensation, including skin burning sensation

5OVERDOSAGE

No specific antidotes for CAPLYTA are known. In managing an CAPLYTA overdose, provide supportive care, including close medical supervision and monitoring and consider the possibility of multiple drug involvement. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

6DESCRIPTION

Lumateperone is an atypical antipsychotic present as lumateperone tosylate salt with the chemical name 4-((6b

CAPLYTA (lumateperone) capsules are for oral administration. Each capsule contains:

42 mg of lumateperone (equivalent to 60 mg of lumateperone tosylate), or
21 mg of lumateperone (equivalent to 30 mg of lumateperone tosylate), or
10.5 mg of lumateperone (equivalent to 15 mg of lumateperone tosylate).

The capsules include the following inactive ingredients: croscarmellose sodium, gelatin, magnesium stearate, mannitol, and talc. Colorants include FD&C blue #1 and red #3 (42 mg), FDA/E172 black iron oxide, FDA/E172 red iron oxide and FD&C red #3 (10.5 mg), and titanium dioxide (42 mg, 21 mg and 10.5 mg).

7HOW SUPPLIED/ STORAGE AND HANDLING

CAPLYTA (lumateperone) capsules are supplied as follows:

Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)

8PATIENT COUNSELING INFORMATION

Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide).

Suicidal Thoughts and Behavior

Advise patients and caregivers to look for the emergence of suicidal thoughts and behaviors, especially early during CAPLYTA treatment and instruct them to report such symptoms to their healthcare provider

Neuroleptic Malignant Syndrome

Counsel patients about a potentially fatal neuroleptic malignant syndrome (NMS), that has been reported with administration of antipsychotic drugs. Advise patients, family members, or caregivers to contact the healthcare provider or to report to the emergency room if they experience signs and symptoms of NMS

Tardive Dyskinesia

Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their healthcare provider if these abnormal movements occur

Metabolic Changes

Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for specific monitoring, including blood glucose, lipids, and weight

Leukopenia/Neutropenia

Advise patients with a pre-existing low WBC or a history of drug induced leukopenia/ neutropenia that they should have their CBC monitored while taking CAPLYTA

Orthostatic Hypotension and Syncope

Educate patients about the risk of orthostatic hypotension and syncope, especially early in treatment, and also at times of re-initiating treatment

Effects on Driving and Operating Heavy Machinery

Caution patients about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that CAPLYTA therapy does not affect them adversely

Heat Exposure and Dehydration

Educate patients regarding appropriate care in avoiding overheating and dehydration

Concomitant Drugs

Advise patients to inform their health care providers of any changes to their current prescription or over-the-counter drugs because there is a potential for clinically significant interactions

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with CAPLYTA. Advise patients that CAPLYTA used during the third trimester may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in the neonate. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to CAPLYTA during pregnancy

Infertility

Advise males and females of reproductive potential that CAPLYTA may impair fertility

Distributed by Intra-Cellular Therapies, Inc.

Bedminster, NJ 07921

CAPLYTA is a registered trademark of Intra-Cellular Therapies, Inc.

9PRINCIPAL DISPLAY PANEL

42 mg 30 Count Bottle Label

Rx Only

30 capsules

NDC 72060-142-40

21 mg 30 Count Bottle Label

Rx Only

30 capsules

NDC 72060-121-40

10.5 mg 30 Count Bottle Label

Rx Only

30 capsules

NDC 72060-110-40

42 mg 7 Count Sample Carton

Professional Sample.

Not for Sale.

NDC 72060-142-07

21 mg 7 Count Sample Carton

Professional Sample.

Not for Sale.

NDC 72060-121-07

10.5 mg 7 Count Sample Carton

Professional Sample.

Not for Sale.

NDC 72060-110-07