TheraRadar
Data updated: May 26, 2026

CAPLYTA (lumateperone tosylate)

Trial Activity: Expansion 6 active trials
Fast Track
CNS Approved 2019-12-20

CAPLYTA is indicated for the treatment of Schizophrenia; Bipolar Disorder; Major Depressive Disorder.

Source: FDA Label • INTRA-CELLULAR • Atypical Antipsychotic
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How CAPLYTA Works

The exact mechanism of action for lumateperone in the treatment of schizophrenia, bipolar depression, and major depressive disorder is unknown. However, its therapeutic effects may be mediated through its activity on specific neurotransmitter receptors within the central nervous system. The drug acts as an antagonist at central serotonin 5-HT2A receptors and as a partial agonist at central dopamine D2 receptors.

Source: FDA Label

Development Insights

Intra-Cellular Therapies, Inc. conducting 10 trials (83%)
8 indications explored (Moderate)
→ major depressive disorder (5 trials)
→ bipolar depression (3 trials)
→ schizophrenia (2 trials)
4
Indications
--
Phase 3 Trials
6
Years on Market

Details

Status
Prescription
First Approved
2019-12-20
Patent Cliff
2040

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE

Companies

INTRA-CELLULAR
Active Ingredient: LUMATEPERONE TOSYLATE

CAPLYTA Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
24 FDA actions from 2019 to 2026 · 3 indication expansions
Apr 2026 SUPPL
Efficacy
FDA Letter Label
Nov 2025 SUPPL
Efficacy
FDA Letter Label
Jun 2023 SUPPL
Label · Labeling
FDA Letter Label

What CAPLYTA Treats

3 indications

CAPLYTA is approved for 3 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Schizophrenia
  • Bipolar Disorder
  • Major Depressive Disorder
Source: FDA Label

CAPLYTA Boxed 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 suicida...

CAPLYTA Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

10

Same target(s) AND same indication — head-to-head.

ERZOFRI
LUYE INNOMIND
2024 2 indic.
OPIPZA
XIAMEN LP
2024 4 indic.

MoA expansion candidates

4

Same target(s), different indications — where else is this mechanism being explored?

ONAPGO
MDD US
2025 1 indic.
BARHEMSYS
ACACIA
2020 1 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

SUBVENITE
OWP PHARMS
2025 5 indic.
RALDESY
KAMAT
2024 1 indic.
Unlock 18 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to CAPLYTA

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

SEROQUEL XR
QUETIAPINE FUMARATE
3 shared
CHEPLAPHARM
Shared indications:
SchizophreniaBipolar DisorderMajor Depressive Disorder
IGALMI
DEXMEDETOMIDINE HYDROCHLORIDE
2 shared
BIOXCEL
Shared indications:
SchizophreniaBipolar Disorder
LATUDA
LURASIDONE HYDROCHLORIDE
2 shared
SUNOVION PHARMS INC
Shared indications:
SchizophreniaBipolar Disorder
View all 20 similar drugs Pro
📋

Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT05356013 results posted IRB21-0974 Ph 2 completed Caplyta in Borderline Personality Disorder
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CAPLYTA FDA Label Details

Indications & Usage

FDA Label (PDF)

CAPLYTA is indicated for the treatment of Schizophrenia; Bipolar Disorder; Major Depressive Disorder.

⚠️ 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 ...

View full patent landscape →
23 OB patents · 8 families · 310 international docs across 21 countries

CAPLYTA Patents & Exclusivity

Latest Patent: Dec 2040
Exclusivity: Nov 2028

Patents (23 active)

US12122792 Expires Dec 10, 2040
US12410195 Expires Dec 10, 2040
US12090155 Expires Jul 7, 2040
US11980617 Expires Oct 27, 2039
US10695345 Expires Aug 30, 2039
US12128043 Expires Aug 30, 2039
US11806348 Expires Aug 30, 2039
US12070459 Expires Aug 30, 2039
US11690842 Expires Aug 30, 2039
US11052084 Expires Aug 30, 2039
US12409176 Expires Mar 15, 2039
US9956227 Expires Dec 3, 2034
US10960009 Expires Dec 3, 2034
US11026951 Expires Dec 3, 2034
USRE48839 Expires Aug 19, 2033
US8648077 Expires Dec 1, 2029
US10117867 Expires May 27, 2029
US9616061 Expires May 27, 2029
US9168258 Expires May 27, 2029
US9199995 Expires Mar 12, 2029
USRE48825 Expires Mar 12, 2029
US9586960 Expires Mar 12, 2029
US10464938 Expires Mar 12, 2028

Exclusivity

I-904 Until Nov 2028
I-904 Until Nov 2028
I-904 Until Nov 2028
I-904 Until Nov 2028
I-904 Until Nov 2028
I-904 Until Nov 2028
I-904 Until Nov 2028
I-904 Until Nov 2028
I-904 Until Nov 2028
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for CAPLYTA

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2040
  • • 279 active patents

Trial Analysis

  • • 12 total trials
  • • Stage: Expansion

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA209500 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment