Lumateperone
Also known as Caplyta, Lumateperone tosylate
Intra-Cellular Therapies, Inc. · Bipolar Depression; Major Depressive Disorder; Bipolar Disorder, Manic; Irritability Associated With Autism Spectrum Disorder; Schizophrenia
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
16
From ClinicalTrials.gov
Latest FDA action
Approved
NDA209500,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- Intra-Cellular Therapies, Inc. Source: Company record for Intra-Cellular Therapies, Inc. (opens in a new tab)
- Indications
- Bipolar Depression; Major Depressive Disorder; Bipolar Disorder, Manic; Irritability Associated With Autism Spectrum Disorder; Schizophrenia Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 209500 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 209500 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 15 Dec 201516 linked trials
- Filed Completed
- Approved Current stageFirst approval 20 Dec 2019
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Lumateperone. Editors add each one with its source.
Filed application
No filed application is on record for Lumateperone. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Lumateperone.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT07747389ClinicalTrials.gov record for NCT07747389 (opens in a new tab)CANDLE | A Study of Lumateperone Versus Placebo in Participants With Major Depressive Disorder | Phase 3 | Not yet recruiting | 585 (estimated) | 20 Sep 2029 (estimated) | No |
| NCT06706674ClinicalTrials.gov record for NCT06706674 (opens in a new tab) | Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients | Phase 3 | Recruiting | 160 (estimated) | 21 Jun 2027 (estimated) | No |
| NCT06690398ClinicalTrials.gov record for NCT06690398 (opens in a new tab) | Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients | Phase 3 | Recruiting | 160 (estimated) | 21 Jun 2027 (estimated) | No |
| NCT06462612ClinicalTrials.gov record for NCT06462612 (opens in a new tab) | Study of Lumateperone in the Treatment of Patients With Bipolar Mania | Phase 3 | Completed | 351 (actual) | 15 May 2026 (actual) | No |
| NCT06462586ClinicalTrials.gov record for NCT06462586 (opens in a new tab) | Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania | Phase 3 | Completed | 354 (actual) | 24 Feb 2026 (actual) | No |
| NCT06372964ClinicalTrials.gov record for NCT06372964 (opens in a new tab) | Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients | Phase 3 | Recruiting | 384 (estimated) | 31 Oct 2031 (estimated) | No |
| NCT06229210ClinicalTrials.gov record for NCT06229210 (opens in a new tab) | Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder | Phase 3 | Recruiting | 300 (estimated) | 28 Apr 2032 (estimated) | No |
| NCT05850689ClinicalTrials.gov record for NCT05850689 (opens in a new tab) | Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder | Phase 3 | Recruiting | 470 (estimated) | 5 Apr 2027 (estimated) | No |
| NCT05061719ClinicalTrials.gov record for NCT05061719 (opens in a new tab) | An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder | Phase 3 | Completed | 812 (actual) | 14 Oct 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT05061719 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT05061719 Serious adverse events (From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.): Lumateperone 42 mg 8 of 809 Source: ClinicalTrials.gov results for NCT05061719 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT05061706ClinicalTrials.gov record for NCT05061706 (opens in a new tab) | Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder | Phase 3 | Completed | 480 (actual) | 12 Apr 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT05061706 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT05061706
Serious adverse events (From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.): Lumateperone 42 mg 2 of 242; Placebo 0 of 238 Source: ClinicalTrials.gov results for NCT05061706 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing NCT05061706 (2), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT04985942ClinicalTrials.gov record for NCT04985942 (opens in a new tab) | Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder | Phase 3 | Completed | 485 (actual) | 22 Feb 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04985942 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT04985942
Serious adverse events (From signing ICF until end of study procedures (~9 weeks), including 6 weeks of double-blind treatment.): Lumateperone 42 mg 1 of 241; Placebo 1 of 243 Source: ClinicalTrials.gov results for NCT04985942 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing NCT04985942 (3), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT04959032ClinicalTrials.gov record for NCT04959032 (opens in a new tab) | Lumateperone for the Prevention of Relapse in Patients With Schizophrenia | Phase 3 | Completed | 592 (actual) | 25 Jul 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04959032 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT04959032
Serious adverse events (From signing ICF until end of study procedures (up to 47 weeks), including 18 weeks of open-label treatment and up to 26 weeks of double-blind treatment.): Lumateperone 42 mg Open-label Treatment Phase 23 of 592; Lumateperone 42 mg Double-blind Treatment Phase 1 of 110; Placebo Double-blind Treatment Phase 7 of 114 Source: ClinicalTrials.gov results for NCT04959032 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT04285515ClinicalTrials.gov record for NCT04285515 (opens in a new tab) | Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder | Phase 3 | Completed | 488 (actual) | 30 Nov 2022 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04285515 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT04285515
Serious adverse events (From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.): Lumateperone 42mg 0 of 240; Placebo 1 of 241 More posted outcomes or analyses are on the study page. All posted results for NCT04285515 Source: ClinicalTrials.gov results for NCT04285515 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing NCT04285515 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT03249376ClinicalTrials.gov record for NCT03249376 (opens in a new tab) | Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally | Phase 3 | Completed | 381 (actual) | 1 Mar 2019 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03249376 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT03249376
Serious adverse events (From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.): Lumateperone 1 of 188; Placebo 0 of 189 Source: ClinicalTrials.gov results for NCT03249376 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing NCT03249376 (3), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT02600507ClinicalTrials.gov record for NCT02600507 (opens in a new tab) | Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression | Phase 3 | Completed | 529 (actual) | 2 Jul 2020 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02600507 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT02600507
Serious adverse events (From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.): Lumateperone 28 mg (ITI-007 40 mg Tosylate) 0 of 176; Lumateperone 42 mg (ITI-007 60 mg Tosylate) 1 of 177; Placebo 0 of 175 Source: ClinicalTrials.gov results for NCT02600507 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing NCT02600507 (2), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT02600494ClinicalTrials.gov record for NCT02600494 (opens in a new tab) | Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression | Phase 3 | Completed | 554 (actual) | 28 Jan 2019 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02600494 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT02600494
Serious adverse events (From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment): Part A Lumateperone 28 mg (ITI-007 40 mg Tosylate) 5 of 180; Part A Lumateperone 42 mg (ITI-007 60 mg Tosylate) 0 of 184; Part A Placebo 1 of 185; Part B Lumateperone 42 mg (ITI-007 60 mg Tosylate) 4 of 127 Source: ClinicalTrials.gov results for NCT02600494 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing NCT02600494 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA209500Action letter for NDA209500 (opens in a new tab) | Supplement 17 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA209500Action letter for NDA209500 (opens in a new tab) | Supplement 16 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA209500Action letter for NDA209500 (opens in a new tab) | Supplement 5 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA209500Action letter for NDA209500 (opens in a new tab) | Supplement 6 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA209500Action letter for NDA209500 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as Lumateperone.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 209500 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07747389 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06706674 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06690398 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06462612 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06462586 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06372964 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06229210 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05850689 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05061719 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05061706 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04985942 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04959032 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04285515 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03249376 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02600507 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02600494 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA209500 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.