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CAPLYTA®

(lumateperone)

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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

CAPLYTA® (lumateperone)

Medical Information

CAPLYTA - Adverse Event - Burning Sensation

Last Updated: 02/06/2026

SUMMARY

  • Lumateperone 28 mg is not an approved dose. Johnson & Johnson does not recommend the use of CAPLYTA in a manner that is inconsistent with the approved labelling.
  • In 2 clinical studies in patients with schizophrenia, burning sensation and skin burning sensation were reported in <1% of patients treated with CAPLYTA 42 mg.1-3
  • In 3 clinical trials in patients with bipolar I or II disorder, burning sensation and skin burning sensation were reported in ≤2% of patients treated with lumateperone. In 1 clinical trial that evaluated patients with bipolar I or II disorder or major depressive disorder (MDD), burning sensation was reported in 2 patients in the CAPLYTA 42 mg group.4-11
  • In an openlabel clinical study in patients with major depressive disorder, burning sensation was reported in 1 patient treated with CAPLYTA 42 mg.12,13
  • In a retrospective pharmacovigilance analysis study that characterized post-marketing adverse event signals for CAPLYTA 42 mg in patients with schizophrenia using the US Food and Drug Administration’s Adverse Event Reporting System (FAERS) over a 4-year period, there were 71 cases of burning sensation and 36 cases of skin burning sensation reported.14

PRODUCT LABELING

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.15

CLINICAL DATA


Summary of Adverse Events in Clinical Studies of CAPLYTA
Study Objective
Patients and Treatment Groups
Outcomes
Schizophrenia
Correll et al (2020)1,2 conducted a randomized, double‑blind, placebo‑controlled, multicenter, phase 3 study (Study 301) that evaluated the efficacy and safety of CAPLYTA in patients with schizophrenia.
  • Patients were randomized (1:1:1) to receive lumateperone 28 mg, CAPLYTA 42 mg, or placebo for 4 weeks. A safety follow-up occurred 2 weeks after the end of treatment period.
  • Safety population: lumateperone 28 mg (n=150), CAPLYTA 42 mg (n=150), placebo (n=149)
  • During the treatment period, burning sensation was reported in 1 patient (0.7%) in the CAPLYTA 42 mg group.
  • The event was mild in severity and considered related to the study drug.
A long-term, open-label, multicenter study (Study 303) evaluated the safety and effectiveness of CAPLYTA 42 mg in patients with schizophrenia.3
  • Patients received CAPLYTA 42 mg (safety population, n=602) for 1 year; this was followed by a 2‑week safety follow-up period and an extended treatment period.
  • During the 1-year treatment period:
    • Burning sensation was reported in 2 patients (0.3%) and skin burning sensation was reported in 1 patient (0.2%).
    • Both burning sensation events were mild in severity and considered related to the study drug.
    • The skin burning sensation event was moderate in severity and considered related to study drug.
    • All events were resolved and none of them led to dose changes or study discontinuation.
Bipolar Depression
A randomized, double‑blind, placebo‑controlled, multicenter, phase 3 study (Study 401, Part A) and its OLE (Part B) evaluated the efficacy, safety, and tolerability of CAPLYTA in patients with MDEs associated with bipolar I or II disorder.4-6
  • In Part A, patients were randomized to receive lumateperone 28 mg, CAPLYTA 42 mg, or placebo for 6 weeks; this was followed by a 2‑week safety follow-up period.
  • Safety population: lumateperone 28 mg (n=180), CAPLYTA 42 mg (n=184), placebo (n=185)
  • In Part B, eligible patients received CAPLYTA 42 mg (n=127) for 6 months, followed by 2‑week safety follow-up period.
  • Part A:
    • During the treatment period, burning sensation was reported in 2 (1.1%) and 2 (1.1%) patients in the lumateperone 28 mg and CAPLYTA 42 mg groups, respectively.
    • In the CAPLYTA 42 mg group, both events were mild in severity and considered related to the study drug. Both events were resolved without any dose changes or study discontinuation.
    • In the lumateperone 28 mg group, both events were moderate in severity while only one of them was related to study drug. Both events were resolved without any dose changes or study discontinuation.
    • Skin burning sensation was reported in 1 patient (0.6%) in the lumateperone 28 mg group.
    • The single skin burning sensation event was mild in severity and considered related to the study drug. The event was not resolved; however, it did not lead to dose changes or study discontinuation.
  • Part B:
    • During the open-label treatment period, emergence of skin burning sensation was reported in 1 patient (0.8%).
    • This event was moderate in severity, related to study drug and led to dose reduction.
    • The event was resolved and did not lead to study discontinuation.
Suppes et al (2023)7,8 conducted a randomized, double‑blind, placebo‑controlled, multicenter, phase 3 study (Study 402) that evaluated the efficacy and safety of CAPLYTA as adjunctive treatment to lithium or valproate in patients with MDEs associated with bipolar I or II disorder.
  • Patients were randomized to receive lumateperone 28 mg, CAPLYTA 42 mg, or placebo for 6 weeks; this was followed by a 2-week safety follow-up period.
  • Safety population: lumateperone 28 mg (n=176), CAPLYTA 42 mg (n=177), placebo (n=175)
  • During the treatment period, burning sensation was reported in 1 patient (0.6%) in the CAPLYTA 42 mg group.
  • The event was moderate in severity and related to study drug. The event led to withdrawal of the drug, and it was resolved after study discontinuation.
A randomized, double‑blind, placebo‑controlled, multicenter, phase 3 study (Study 403) evaluated the efficacy and safety of CAPLYTA monotherapy in patients with MDEs associated with bipolar I or II disorder or MDD.9
  • Patients were randomized to receive CAPLYTA 42 mg or placebo for 6 weeks; this was followed by a 2‑week safety follow-up period
  • Safety population: CAPLYTA 42 mg (n=240), placebo (n=241)
  • During the treatment period, burning sensation was reported in 2 patients (0.8%) in the CAPLYTA 42 mg group.
  • Both burning sensation events were considered related to the study drug.
  • One of the events was mild and the other event was moderate in severity.
  • Both events were resolved and none of them led to dose changes or study discontinuation.
Calabrese et al (2021)10,11 conducted a phase 3, randomized, double-blind, placebo‑controlled study (Study 404) to evaluate the efficacy and safety of CAPLYTA for the treatment of MDEs associated with bipolar I or bipolar II disorder.
  • Patients were randomized (1:1) to receive CAPLYTA 42 mg or placebo for 6 weeks; this was followed by a 2week safety follow-up period.
  • Safety population: CAPLYTA 42 mg (n=188), placebo (n=189)
  • During the treatment period, burning sensation was reported in 1 patient (0.5%) in the CAPLYTA 42 mg group.
  • The event was mild in severity and considered related to the study drug.
  • The event did not lead to dose change or discontinuation, and the event was resolved without any medication.
MDD
Earley et al (2025)12,13 presented an open-label, multicenter study (Study 503) to evaluate the safety and tolerability of CAPLYTA 42 mg as adjunctive treatment to ADT in patients with MDD.
  • Patients received CAPLYTA 42 mg (safety population, n=809) as adjunctive treatment to ADT for 26 weeks; this was followed by a 2-week safety follow-up period.
  • Burning sensation was reported in 1 patient (0.1%).
  • The event was mild in severity and considered related to the study drug.
  • The event occurred in a patient who received placebo during the lead-in study, and the time of first onset of the event was ≤4 weeks of OLE.
  • The event was resolved and it did not lead to dose change in the study drug or in ADT.
Abbreviations: ADT, antidepressant therapy; AE, adverse event; CI, confidence interval; MDD, major depressive disorder; MDE, major depressive episode; OLE, open-label extension.

Post-Marketing FAERS Study

Sun et al (2024)14 conducted a retrospective pharmacovigilance analysis to characterize post‑marketing AE signals for CAPLYTA 42 mg in patients with schizophrenia using FAERS, and to identify potential AEs not listed in labeling to inform clinical safety monitoring.

There were 1762 CAPLYTA-related AEs reported from Quarter 4 (Q4) 2019 to Q4 2023 in the FAERS database.

  • There were 71 cases of burning sensation reported with a reporting odds ratio (ROR) of 15.25 (95% confidence interval [CI]: 12.06–19.28), a proportional reporting ratio (PRR) of 15.05 (chi-square [χ²]: 928.38), an empirical Bayes geometric mean (EBGM) of 14.99 (lower limit of the 95% CI of EBGM [EBGM05]: 12.32) and an information component (IC) of 3.91 (lower limit of the 95% CI of the IC [IC025]: 2.24).
  • There were 36 cases of skin burning sensation reported with a ROR of 5.89 (95% CI: 4.248.18), a PRR of 5.86 (χ²: 144.92), an EBGM of 5.85 (EBGM05: 4.44), and an IC of 2.55 (IC025: 0.88)
  • Limitations of the FAERS database include its voluntary reporting nature, limitations of the quality of information reported and inability to determine causality between drug use and AEs.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 19 January 2026.

 

References

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1 Correll CU, Davis RE, Weingart M, et al. Efficacy and safety of lumateperone for treatment of schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2020;77(4):349-358.  
2 Data on File. CAPLYTA. Clinical Study Report of Study 301. Intra-Cellular Therapies, Inc; 2016.  
3 Data on File. CAPLYTA. Clinical Study Report of Study 303. Intra-Cellular Therapies, Inc; 2025.  
4 Correll CU, Durgam S, Kozauer SG, et al. Lumateperone monotherapy for major depressive episodes associated with bipolar disorder: efficacy and safety in a randomized placebo-controlled trial. [published online ahead of print July 23, 2025]. Int Clin Psychopharmacol. doi:10.1097/yic.0000000000000597.  
5 Tohen M, Durgam S, Kozauer SG, et al. Long-term safety and tolerability of lumateperone 42 mg in patients with bipolar disorder: results from a 6-month open-label extension study. [Nov 6, 2025]. Int Clin Psychopharmacol. doi:10.1097/yic.0000000000000596.  
6 Data on File. CAPLYTA. Clinical Study Report of Study 401. Intra-Cellular Therapies, Inc; 2021.  
7 Suppes T, Durgam S, Kozauer SG, et al. Adjunctive lumateperone (ITI‐007) in the treatment of bipolar depression: results from a randomized placebo‐controlled clinical trial. Bipolar Disord. 2023;25(6):478-488.  
8 Data on File. CAPLYTA. Clinical Study Report of Study 402. Intra-Cellular Therapies, Inc; 2021.  
9 Data on File. CAPLYTA. Clinical Study Report of Study 403. Intra-Cellular Therapies, Inc; 2023.  
10 Data on File. CAPLYTA. Clinical Study Report of Study 404. Intra-Cellular Therapies, Inc; 2020.  
11 Calabrese JR, Durgam S, Satlin A, et al. Efficacy and safety of lumateperone for major depressive episodes associated with bipolar I or bipolar II disorder: a phase 3 randomized placebo-controlled trial. Am J Psychiatry. 2021;178(12):1098-1106.  
12 Earley WR, Durgam S, Kozauer SG, et al. Long-term adjunctive lumateperone treatment in major depressive disorder: results from a six-month open-label extension study. Poster presented at: American Society of Clinical Psychopharmacology (ASCP) Annual Meeting; May 27-30, 2025; Scottsdale, AZ.  
13 Data on File. CAPLYTA. Clinical Study Report of Study 503. Intra-Cellular Therapies, Inc; 2025.  
14 Sun S, Zhang Y, Wu H, et al. Analysis of lumateperone data for patients with schizophrenia using related adverse events from the FDA adverse reporting system. Expert Opin Drug Saf. 2025;24(9):1083-1093.  
15 CAPLYTA (lumateperone) [Prescribing Information]. Bedminster, NJ: Intra-Cellular Therapies, Inc; https://www.intracellulartherapies.com/docs/caplyta_pi.pdf