{
 "query": "lumateperone",
 "ingredient": "lumateperone",
 "slug": "lumateperone",
 "rxcui": "2275602",
 "brands": [
  "Caplyta"
 ],
 "names": [
  "lumateperone",
  "lumateperone tosylate"
 ],
 "classes": [
  {
   "id": "N05AD",
   "name": "Butyrophenone derivatives"
  }
 ],
 "alternatives": [
  "benperidol",
  "bromperidol",
  "droperidol",
  "haloperidol",
  "metylperon",
  "pipamperone",
  "trifluperidol"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 1
  },
  "boxed_warning": "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 app...",
  "indications_and_usage": "is indicated for: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ] . 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 [see Clinical Studies (14.2) ] . Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14.3 ) ]. CAPLYTA is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 ) 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. ( 1 ) Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. ( 1 )",
  "contraindications": "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. CAPLYTA is contraindicated in patients with history of hypersensitivity reaction to lumateperone or any components of CAPLYTA. ( 4 )",
  "warnings_and_cautions": "Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke and transient ischemic attack). ( 5.3 ) Neuroleptic Malignant Syndrome: If NMS is suspected, immediately discontinue CAPLYTA and provide intensive symptomatic treatment and monitoring. ( 5.4 ) Tardive Dyskinesia: If signs and symptoms of TD occur consider discontinuing CAPLYTA treatment. ( 5.5 ) Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain. ( 5.6 ) Leukopenia, Neutropenia, and Agranulocytosis : In patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia, perform complete blood counts (CBC). Consider discontinuing CAPLYTA if clinically significant decline in WBC occurs in absence of other causative factors. Discontinue CAPLYTA in patients with clinically significant neutropenia or ANC < 1000/mm 3 and monitor closely until the neutropenia resolve. ( 5.7 ) Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure in patients who are vulnerable to hypotension. ( 5.8 ) Seizures: Use cautiously in patients with a history of s...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning , Warnings and Precautions (5.1) ] Suicidal Thoughts and Behaviors [see Boxed Warning , Warnings and Precautions (5.2) ] Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-related Psychosis [see Warnings and Precautions (5.3) ] Neuroleptic Malignant Syndrome [see Warnings and Precautions (5.4) ] Tardive Dyskinesia [see Warnings and Precautions (5.5) ] Metabolic Changes [see Warnings and Precautions (5.6) ] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.7) ] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.8) ] Falls [see Warnings and Precautions (5.9) ] Seizures [see Warnings and Precautions (5.10) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.11) ] Body Temperature Dysregulation [see Warnings and Precautions (5.12) ] Dysphagia [see Warnings and Precautions (5.13) ] Most common adverse reactions in clinical trials (incidence \u2265 5% and greater than twice placebo) were ( 6.1 ): Schizophr...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage, adjunctive treatment of major depressive disorder ( 1 ) 11/2025",
  "information_for_patients": "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 [see Boxed Warning, Warnings and Precautions (5.2) ]. 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 [see Warnings and Precautions (5.4) ]. Tardive Dyskinesia Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their healthcare provider if these abnormal movements occur [see Warnings and Precautions (5.5) ]. 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 [see Warnings and...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 04/2026 MEDICATION GUIDE CAPLYTA (kap-LITE-ah) (lumateperone) capsules, for oral use What is the most important information I should know about CAPLYTA? CAPLYTA may cause serious side effects, including : Increased risk of death in elderly people with dementia related psychosis. Medicines like CAPLYTA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). CAPLYTA is not approved for the treatment of people with dementia-related psychosis. Increased risk of suicidal thoughts and actions. CAPLYTA and antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important...",
  "clinical_studies": "14.1 Schizophrenia CAPLYTA was evaluated for the treatment of schizophrenia in adults in two placebo-controlled trials (i.e., Studies 1 and 2). Study 1 (Adults with Schizophrenia) Study 1 Design: Study 1 (NCT01499563) was a four-week, randomized, double-blind, placebo-controlled, multi-center study in adult patients with a diagnosis of schizophrenia according to the DSM-IV-TR criteria. The primary efficacy measure was change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 4. The PANSS is a 30-item scale used to measure symptoms of schizophrenia. Each item is rated by a clinician on a seven-point scale. A score of 1 indicates the absence of symptoms, and a score of 7 indicates extremely severe symptoms. The PANSS total score ranges from 30 to 210 with higher scores reflecting greater overall symptom severity. A total of 335 patients were randomized to receive oral CAPLYTA 42 mg, CAPLYTA 84 mg (two times the recommended daily dose), an active comparator, or placebo once daily. The study was not designed to allow for efficacy comparison of CAPLYTA and the active comparator. Study 1 Baseline Demographics: Demographic and baseline disease characteri...",
  "brand_name": "CAPLYTA",
  "manufacturer": "Intra-Cellular Therapies, Inc",
  "application_number": "NDA209500",
  "pharm_class_epc": [
   "Atypical Antipsychotic [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250620",
  "set_id": "db730b06-6351-47fd-8183-e61e61bbead5",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 7091,
  "serious": 2010,
  "death": 61,
  "hospitalization": 570,
  "primary_suspect": 7065,
  "top_reactions": [
   [
    "Dizziness",
    719
   ],
   [
    "Nausea",
    549
   ],
   [
    "Headache",
    488
   ],
   [
    "Somnolence",
    416
   ],
   [
    "Off Label Use",
    379
   ],
   [
    "Drug Ineffective",
    325
   ],
   [
    "Mania",
    284
   ],
   [
    "Anxiety",
    282
   ],
   [
    "Sedation",
    274
   ],
   [
    "Feeling Abnormal",
    272
   ],
   [
    "Insomnia",
    252
   ],
   [
    "Fatigue",
    249
   ],
   [
    "Vomiting",
    238
   ],
   [
    "Suicidal Ideation",
    224
   ],
   [
    "Burning Sensation",
    216
   ]
  ],
  "by_year": {
   "2019": 1,
   "2020": 170,
   "2021": 363,
   "2022": 980,
   "2023": 621,
   "2024": 1997,
   "2025": 1614,
   "2026": 1344
  },
  "by_year_primary": {
   "2019": 1,
   "2020": 170,
   "2021": 363,
   "2022": 973,
   "2023": 613,
   "2024": 1994,
   "2025": 1609,
   "2026": 1341
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 6,
  "nda": 1,
  "anda": 0,
  "first_approval": "20191220",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 1,
  "labeling_recent": 1,
  "sponsors": [
   "ALKEM LABS LTD",
   "AUROBINDO PHARMA LIMITED",
   "DR. REDDY'S LABORATORIES LIMITED",
   "HETERO LABS LIMITED",
   "INTRA-CELLULAR",
   "MSN LABORATORIES PRIVATE LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/20/2019"
 },
 "trials": {
  "total": 38,
  "completed": 20,
  "terminated": 3,
  "with_results": 15,
  "industry": 32,
  "phase3": 21,
  "results_share": 0.75,
  "terminated_share": 0.07894736842105263
 },
 "pubmed": {
  "rct": 15,
  "meta": 8,
  "recent_rct": 14,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 10760096.7,
  "records": 137081,
  "by_name": [
   [
    "Caplyta",
    10760096.7
   ]
  ],
  "names_checked": [
   "lumateperone",
   "Caplyta"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 159224,
  "beneficiaries": 27010,
  "spend": 268479293.41,
  "by_brand": [
   {
    "brand": "Caplyta",
    "claims": 159224,
    "per_claim": 1686.1735254,
    "is_generic": false
   }
  ],
  "per_claim": 1686.1735254107423
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4944,
  "fills": 159224,
  "per_million": 31050.595387630005,
  "ratio": 11.213852958192744,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 50,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "31,051 FDA reports naming it as the suspect drug per million Medicare fills, 11.2x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (0.1x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 40,
   "letter": "F",
   "why": [
    "15 randomized trials and 8 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 55,
   "letter": "D",
   "why": [
    "Pharma paid doctors $10,760,097 tied to this drug last year (-45)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 57,
 "grade": "D",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are dizziness, nausea, headache, somnolence. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over benperidol, bromperidol, droperidol? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}