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CAPLYTA®

(lumateperone)

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CAPLYTA® (lumateperone)
Medical Information

CAPLYTA - Adverse Events - Dyskinesia

Last Updated: 05/28/2026

SUMMARY

  • If signs and symptoms of tardive dyskinesia appear in CAPLYTA-treated patients, consider drug discontinuation.1
  • In 3 placebo-controlled, 4- to 6-week trials, dyskinesia was reported in 0 patients receiving CAPLYTA 42 mg (n=406), 1 patient (0.2%) receiving placebo (n=412), and 0 patients receiving risperidone (n=255) (narrow standardized Medical Dictionary for Regulatory Activities query [SMQ]). Tardive dyskinesia was reported in 2 patients (0.5%) receiving CAPLYTA 42 mg, 0 patients receiving placebo, and 0 patients receiving risperidone (narrow SMQ).2 
  • In a long-term, open-label, 1-year study, dyskinesia and tardive dyskinesia were reported in 1 patient each (0.2%; N=602) receiving CAPLYTA 42 mg (narrow SMQ).3 
  • In a 6-week, phase 3, randomized, double-blind, placebo-controlled study, 1 patient (0.5%; n=188) in the CAPLYTA 42 mg group experienced mild dyskinesia.4 
  • In a pooled analysis of two 6-week, placebo-controlled trials of CAPLYTA 42 mg monotherapy and a placebo-controlled trial of CAPLYTA 42 mg adjunctive to lithium or valproate, dyskinesia was reported in 1 patient (0.3%) receiving CAPLYTA 42 mg monotherapy (n=372).5 
  • In a 6-week, placebo-controlled trial of CAPLYTA 42 mg adjunctive to antidepressant therapy (ADT), dyskinesia was reported in 0 patients receiving CAPLYTA 42 mg + ADT (n=241) and in 1 patient (0.4%) receiving placebo + ADT (n=243) (narrow SMQ).6,7 
  • In a 26-week, open-label trial of CAPLYTA 42 mg adjunctive to ADT, dyskinesia was reported in 2 patients (0.2%; N=809) (narrow SMQ).8,9 

PRODUCT LABELING

Tardive dyskinesia may develop in patients treated with antipsychotic drugs, including CAPLYTA. Tardive dyskinesia can develop after a relatively brief treatment period at low dosages and may also occur after discontinuation of treatment. If antipsychotic treatment is discontinued, tardive dyskinesia may partially or completely remit. Antipsychotic treatment, however, may suppress or partially suppress the signs and symptoms of tardive dyskinesia, and may mask the underlying process. The effect that symptomatic suppression has upon the long-term course of tardive dyskinesia is unknown.1

The tardive dyskinesia risk appears to be highest among the elderly, especially elderly women, but it is not possible to predict which patients are likely to develop tardive dyskinesia. The tardive dyskinesia risk and the likelihood that tardive dyskinesia will become irreversible increase with the duration of antipsychotic drug treatment and the cumulative dosage.1

Periodically reassess the need for continued treatment. If signs and symptoms of tardive dyskinesia appear in CAPLYTA-treated patients, consider drug discontinuation. However, some patients may require CAPLYTA treatment despite the presence of tardive dyskinesia.1

CLINICAL DATA


Summary of Clinical Studies
Study
Patients and Treatment Groups
Outcomes
Schizophrenia
Three placebo-controlled, 4- to 6-week trials evaluated the safety of CAPLYTA in adult patients with schizophrenia.2
  • CAPLYTA 42 mg (n=406)
  • Placebo (n=412)
  • Risperidone (n=255)
  • Dyskinesia was reported in 0 patients receiving CAPLYTA 42 mg, 1 patient (0.2%) receiving placebo, and 0 patients receiving risperidone (narrow SMQ).
  • Tardive dyskinesia was reported in 2 patients (0.5%) receiving CAPLYTA 42 mg, 0 patients receiving placebo, and 0 patients receiving risperidone (narrow SMQ).
An open-label, multicenter study (Study 303), evaluated the safety of CAPLYTA in patients with schizophrenia, comprising of a 1-year treatment period followed by a 2-week safety follow-up and an extended treatment period.3 
  • Patients received CAPLYTA 42 mg (n=602)
  • Dyskinesia and tardive dyskinesia were reported in 1 patient each (0.2%) (narrow SMQ).
Bipolar Depression
Calabrese et al (2021)4 conducted a 6-week, phase 3, randomized, double-blind, placebo-controlled study (Study 404), which included 6 weeks of treatment followed by a 2-week safety follow-up period in patients with bipolar I or bipolar II disorder experiencing an MDE. 
  • Safety population comprised CAPLYTA 42 mg (n=188) and placebo (n=189) groups.
  • Mild dyskinesia was reported in 1 patient (0.5%) in the CAPLYTA 42 mg group on day 43 and was considered drug-related.
Escher et al (2022)5 conducted a pooled clinical analysis of patients with bipolar I or bipolar II disorder who were experiencing an MDE that included data from two 6-week, placebo-controlled trials of CAPLYTA monotherapy (Studies 401 and 404) and a placebo-controlled trial of CAPLYTA 42 mg adjunctive to lithium or valproate (Study 402). 
  • Safety population from the pooled monotherapy trials comprised CAPLYTA 42 mg monotherapy (n=372) and Placebo monotherapy (n=374) groups, while patients in the adjunctive trials comprised CAPLYTA 42 mg adjunctive to lithium or valproate (n=177) and Placebo adjunctive to lithium or valproate (n=175) groups.
  • One patient (0.3%) on CAPLYTA 42 mg monotherapy experienced mild dyskinesia.
Major Depressive Disorder
Durgam et al (2025)6 conducted a phase 3, randomized, double-blind, placebo‑controlled, fixed‑dose study (Study 501), to assess the efficacy and safety of CAPLYTA adjunctive to ADT in patients with MDD who had an inadequate response to ADT, comprising of a 6-week treatment period followed by a 2-week safety follow-up.7
  • Safety population comprised of CAPLYTA 42 mg (n=241) and placebo (n=243) groups
  • Dyskinesia was reported in 0 patients receiving CAPLYTA 42 mg + ADT and in 1 patient (0.4%) receiving placebo + ADT (narrow SMQ).
Durgam et al (2026)8 conducted an open-label, multicenter study (Study 503) to evaluate the safety and tolerability of CAPLYTA as adjunctive treatment to ADT in patients with MDD, comprising of a 26-week treatment period followed by a 2-week safety follow-up.9
  • Patients received CAPLYTA 42 mg (n=809) as adjunctive treatment to ADT.
  • Dyskinesia was reported in 2 patients (0.2%) (narrow SMQ).
Abbreviations: ADT, antidepressant therapy; MDD, major depressive disorder; MDE, major depressive episode; SMQ, standard Medical Dictionary for Regulatory Activities query.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 06 May 2026.

 

References

Show
1 CAPLYTA (lumateperone) [Prescribing Information]. Titusville, NJ: Intra-Cellular Therapies, Inc; https://www.intracellulartherapies.com/docs/caplyta_pi.pdf
2 Data on File. CAPLYTA. Integrated Summary of Safety. Intra-Cellular Therapies, Inc; 2025.  
3 Data on File. CAPLYTA. Clinical Study Report of Study 303. Intra-Cellular Therapies, Inc; 2025.  
4 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.  
5 Escher T, Durgam S, Kozauer SG, et al. Lumateperone in the treatment of major depressive episodes associated with bipolar I or bipolar II disorder: evaluation of extrapyramidal and motor symptoms in late-phase clinical trials [abstract]. Neuropsychopharmacology. 2022;47(Suppl. 1):202-203. Abstract P243.  
6 Durgam S, Earley WR, Kozauer SG, et al. Lumateperone as adjunctive therapy in patients with major depressive disorder: results from a randomized, double-blind, phase-3 trial. J Clin Psychiatry. 2025;86(4):25m15848.  
7 Data on File. CAPLYTA. Clinical Study Report of Study 501. Intra-Cellular Therapies, Inc; 2024.  
8 Durgam S, Earley WR, Kozauer SG, et al. Long-term adjunctive lumateperone 42 mg treatment in major depressive disorder: results from a 6-month open-label extension study. Eur Neuropsychopharmacol. 2026;108:112786.  
9 Data on File. CAPLYTA. Clinical Study Report of Study 503. Intra-Cellular Therapies, Inc; 2025.  

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