Ulotaront

(Lumateperone)

ApprovedSmall molecule

Lumateperone is used to treat depression and schizophrenia by helping to restore balance in certain brain chemicals that affect mood and thinking.[2] Ulotaront is currently approved and in use across 12 indications[4].[1]

Ulotaront is one of 338 small molecule programs targeting Depressive Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

337

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Depressive DisorderApproved

Schizoaffective DisorderActive, not recruiting

Alzheimer DiseaseApproved

InsomniaApproved

ApathyActive, not recruiting

PsychosisActive, not recruiting

Autism Spectrum DisorderActive, not recruiting

Major Depressive DisorderApproved

SchizophreniaApproved

Bipolar DisorderApproved

Depressive DisorderApproved

Approved

Schizoaffective DisorderPhase 1

Active, not recruiting

Alzheimer DiseaseApproved

Approved

InsomniaApproved

Approved

ApathyPhase 3

Active, not recruiting

PsychosisApproved

Active, not recruiting

Autism Spectrum DisorderPhase 1

Active, not recruiting

Major Depressive DisorderApproved

Approved

SchizophreniaApproved

Approved

Bipolar DisorderApproved

Approved

Showing 10 of 12 indications

Competition

Competitive Landscape

583 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Ulotaront

IIntra-Cellular Therapies, Inc.

Approved

5 2

Celexa

AbbVie

Preclinical

4 3

Ozempic

Novo Nordisk

Preclinical

1 4

Resotran

Takeda

Preclinical

1 5

Inapsine

Alnylam Pharmaceuticals

Preclinical

1 6

Ibrance

Catapres

1 8

Compazine

GGlaxo Dba Glaxosmithkline

Preclinical

1 9

Rapamune

PPrism Pharmaceuticals

Preclinical

1 10

Persantine

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1Recruiting

Autism Spectrum Disorder

NCT06557902

Q4 2026

Post-ApprovalRecruiting

Schizophrenia

NCT06174116

Phase 3Recruiting

Apathy

NCT06482554

Q2 2027

Phase 3Recruiting

Major Depressive Disorder

NCT05850689

Phase 3Recruiting

Irritability Associated With Autism Spectrum Disorder

NCT06706674

Q3 2027

Phase 3Recruiting

Irritability Associated With Autism Spectrum Disorder

NCT06690398

Clinical

Trials by Indication[1]

Major Depressive Disorder6 trials

Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Completed·IIntra-Cellular Therapies, Inc.·Phase 3·NCT04985942·485 enrolled

An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Completed·IIntra-Cellular Therapies, Inc.·Phase 3·NCT05061719·812 enrolled

Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

Completed·IIntra-Cellular Therapies, Inc.·Phase 3·NCT04285515·488 enrolled

Show 3 more trials

Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Completed·IIntra-Cellular Therapies, Inc.·Phase 3·NCT05061706·480 enrolled

Neurocircuitry Mechanisms and Efficacy of Lumateperone as Adjunctive Therapy for Major Depressive Disorder and History of Early Life Abuse

Not yet recruiting·UUniversity of Texas at Austin·Phase 4·NCT07369115·50 enrolled

A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Recruiting·IIntra-Cellular Therapies, Inc.·Phase 3·NCT05850689·470 enrolled

Schizophrenia5 trials

Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia

Recruiting·UUniversity of Massachusetts, Worcester·Phase 4·NCT06174116·50 enrolled

Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

Completed·IIntra-Cellular Therapies, Inc.·Phase 3·NCT04959032·228 enrolled

Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia

Completed·IIntra-Cellular Therapies, Inc.·Phase 1·NCT04709224·37 enrolled

Show 2 more trials

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

Recruiting·IIntra-Cellular Therapies, Inc.·Phase 3·NCT06229210·300 enrolled

A Phase 1b, Open-label Study to Determine the Pharmacokinetics, Safety, and Tolerability of Single, Ascending Doses of Lumateperone Long-acting Injectable Formulations Administered Intramuscularly to Patients With Schizophrenia or Schizoaffective Disorder

Completed·IIntra-Cellular Therapies, Inc.·Phase 1·NCT06627413·52 enrolled

Bipolar Depression4 trials

Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

Completed·IIntra-Cellular Therapies, Inc.·Phase 3·NCT03249376·381 enrolled

Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

Completed·IIntra-Cellular Therapies, Inc.·Phase 3·NCT02600507·529 enrolled

The Effects of Lumateperone on Obesity and Physiologic Aging and Their Correlation With Antidepressant Response in Bipolar Depression

Not yet recruiting·MMassachusetts General Hospital·Approved·NCT07699445·25 enrolled

Show 1 more trial

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years

Recruiting·IIntra-Cellular Therapies, Inc.·Phase 3·NCT06372964·384 enrolled

Treatment2 trials

Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania

Recruiting·IIntra-Cellular Therapies, Inc.·Phase 3·NCT06462586·350 enrolled

Study of Lumateperone in the Treatment of Patients With Bipolar Mania

Recruiting·IIntra-Cellular Therapies, Inc.·Phase 3·NCT06462612·350 enrolled

Irritability Associated With Autism Spectrum Disorder2 trials

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age

Recruiting·IIntra-Cellular Therapies, Inc.·Phase 3·NCT06706674·160 enrolled

Recruiting·IIntra-Cellular Therapies, Inc.·Phase 3·NCT06690398·160 enrolled

5 more indications

Efficacy1 trial

Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine

Withdrawn·UUniversity of New Mexico·Phase 4·NCT05890768

Apathy1 trial

Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.

Recruiting·LLouisiana State University Health Sciences Center Shreveport·Phase 3·NCT06482554·80 enrolled

Schizoaffective Disorder1 trial

Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder

Completed·IIntra-Cellular Therapies, Inc.·Phase 1·NCT04779177·26 enrolled

Autism Spectrum Disorder1 trial

Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder

Recruiting·IIntra-Cellular Therapies, Inc.·Phase 1·NCT06557902·26 enrolled

Depression1 trial

Comparison Of Efficacy And Safety Of Lumateperone And Cariprazine as Adjunctive Treatment in Bipolar I Depression

Not yet recruiting·WWatim Medical & Dental College·Approved·NCT07676669·140 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 22, 2022

CAPLYTA

NDA NDA209500

Sources

References

[1]
ClinicalTrials.gov — 24 trial records for Lumateperone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ulotaront drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Lumateperone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Lumateperone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA209500). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Ulotaront. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Intra-Cellular Therapies, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serotonin Transporter Inhibitor; Dopamine D2 Receptor Antagonist; Serotonin 2a (5-Ht2a) Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: IIntra-Cellular Therapies, Inc.

Patent Landscape[6]

Patent Cliff

Mar 12, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10464938Mar 12, 2028

9199995Mar 12, 2029

RE48825Mar 12, 2029

9586960Mar 12, 2029

10117867May 27, 2029

20 more patents

9168258May 27, 2029

9616061May 27, 2029

8648077Dec 1, 2029

8598119Dec 28, 2029

RE48839Aug 19, 2033

9956227Dec 3, 2034

10960009Dec 3, 2034

11026951Dec 3, 2034

12409176Mar 15, 2039

11052084Aug 30, 2039

12070459Aug 30, 2039

11806348Aug 30, 2039

12128043Aug 30, 2039

10695345Aug 30, 2039

11690842Aug 30, 2039

11980617Oct 27, 2039

12090155Jul 7, 2040

12122792Dec 10, 2040

12410195Dec 10, 2040

11753419Dec 10, 2040

Ulotaront

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q2 2027

Q3 2027

Trials by Indication[1]

Major Depressive Disorder6 trials

Schizophrenia5 trials

Bipolar Depression4 trials

Treatment2 trials

Irritability Associated With Autism Spectrum Disorder2 trials

Efficacy1 trial

Apathy1 trial

Schizoaffective Disorder1 trial

Autism Spectrum Disorder1 trial

Depression1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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