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 261 small molecule programs targeting Major Depressive Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

260

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Major Depressive DisorderRecruiting

InsomniaApproved

Depressive DisorderApproved

Bipolar DisorderApproved

Alzheimer DiseaseApproved

PsychosisActive, not recruiting

DepressionNot yet recruiting

Bipolar DepressionRecruiting

Stuttering, AdultRecruiting

Depressive Disorder, MajorNot yet recruiting

Major Depressive DisorderApproved

Recruiting

InsomniaApproved

Approved

Depressive DisorderApproved

Approved

Bipolar DisorderApproved

Approved

Alzheimer DiseaseApproved

Approved

PsychosisApproved

Active, not recruiting

DepressionApproved

Not yet recruiting

Bipolar DepressionApproved

Recruiting

Stuttering, AdultPhase 2

Recruiting

Depressive Disorder, MajorPhase 3

Not yet recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Ulotaront

IIntra-Cellular Therapies, Inc.

Approved

5 2

Ozempic

Novo Nordisk

Preclinical

1 3

Resotran

Takeda

Preclinical

1 4

Inapsine

Jazz Pharmaceuticals

Preclinical

1 5

Depakote

Ibrance

Lunesta

3 8

Luvox

SSolvay Pharmaceuticals

Preclinical

1 9

Catapres

Boehringer Ingelheim

Preclinical

1 10

Rapamune

PPrism Pharmaceuticals

Preclinical

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

Timeline

Expected Milestones

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

ApprovedNot yet recruiting

Depression

NCT07676669

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

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

Show 3 more trials

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

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

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

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

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

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

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

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

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

Bipolar Disorder, Manic2 trials

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)

Completed·IIntra-Cellular Therapies, Inc.·Phase 3·NCT06462586·354 enrolled

Completed·IIntra-Cellular Therapies, Inc.·Phase 3·NCT06462612·351 enrolled

9 more indications

Efficacy1 trial

Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine

Withdrawn·UUniversity of New Mexico·Phase 4·NCT05890768

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

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

Treatment Resistant Depression (TRD)1 trial

Lumateperone for Late-Life Depression

Recruiting·EEric Lenze·Phase 3·NCT07623135·100 enrolled

Social Anxiety Disorder (SAD)1 trial

Caplyta® in the Treatment of Social Anxiety Disorder: A Double-Blind Study

Recruiting·JJason Careri·Approved·NCT07799493·40 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

Depressive Disorder, Major1 trial

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Fixed Doses of Lumateperone Administered as Monotherapy in Participants With Major Depressive Disorder and an Open-label Long-term Extension Treatment With Lumateperone

Not yet recruiting·IIntra-Cellular Therapies, Inc.·Phase 3·NCT07747389·585 enrolled

Stuttering, Adult1 trial

A Single-Center, Double-Blind, Placebo-Controlled, Study to Evaluate Lumateperone, Flexible Doses of 21mg or 42mg in Patients With Moderate to Severe Childhood Onset Fluency Disorder, Stuttering.

Recruiting·CCSTrials Inc.·Phase 2·NCT07734103·24 enrolled

Autism Spectrum Disorder1 trial

An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumateperone in Pediatric Patients, Ages 5 to Less Than 13 Years, Diagnosed With Autism Spectrum Disorder

Completed·IIntra-Cellular Therapies, Inc.·Phase 1·NCT06557902·33 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 22, 2022

CAPLYTA

NDA NDA209500

Sources

References

[1]
ClinicalTrials.gov — 28 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

Q4 2026

Q2 2027

Q3 2027

Trials by Indication[1]

Major Depressive Disorder6 trials

Schizophrenia5 trials

Bipolar Depression4 trials

Irritability Associated With Autism Spectrum Disorder2 trials

Bipolar Disorder, Manic2 trials

Efficacy1 trial

Schizoaffective Disorder1 trial

Apathy1 trial

Treatment Resistant Depression (TRD)1 trial

Social Anxiety Disorder (SAD)1 trial

Depression1 trial

Depressive Disorder, Major1 trial

Stuttering, Adult1 trial

Autism Spectrum Disorder1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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