Drugs / Lumateperone
Lumateperone
also known as
ITI-007 · Caplyta · ITI-007 tosylate · ITI-722 · Lumateperona · lumateperone tosylate · X500-E2 · X500-E3 · +2 more
Small molecule targets DRD2, HTR2A, SLC6A4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed schizophrenia 1 milestone | |||||
| Filed | US (FDA) | CAPLYTA | schizophrenia | 2025-07-08 | “CAPLYTA® with long-term data evaluating the safety and efficacy of the medication for the prevention of relapse in schizophrenia was recentlysubmittedto the FDA.” jnj.com ↗ “CAPLYTA®with long-term data evaluating the safety and efficacy of the medication for the prevention of relapse in schizophrenia wassubmittedto the FDA.” jnj.com ↗ “Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone)” jnj.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansions (3) | US (FDA) | CAPLYTA | — | 2021-12-17 – 2026-04-24 | fda.gov ↗ |
| Approved | US (FDA) | CAPLYTA | — | 2019-12-20 | fda.gov ↗ |
Trials 34
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06627413 | Aug 2024 → Nov 2025 | schizophrenia | Intra-Cellular Therapies, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06557902 | May 2024 → Jul 2026 overdue | autism spectrum disorder | Intra-Cellular Therapies, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT04779177 | Mar 2021 → Jul 2022 | schizophrenia | Intra-Cellular Therapies, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04709224 | Dec 2020 → May 2022 | schizophrenia | Intra-Cellular Therapies, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02078310 | Feb → Aug 2014 | Alzheimer disease | Intra-Cellular Therapies, Inc. | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT05356013 | May 2023 → Dec 2025 | borderline personality disorder | University of Chicago | Completed | No outcome recorded |
| Phase 2 | NCT03817528 | Mar 2019 → Sep 2020 | schizophrenia | New York State Psychiatric Institute | Terminated | No outcome recorded |
| Phase 2 | NCT02288845 | Oct 2014 → Jul 2015 | schizophrenia | Intra-Cellular Therapies, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01499563 | Dec 2011 → Aug 2013 | schizophrenia | Intra-Cellular Therapies, Inc. | Completed | Met primary |
| Phase 320 trials · 6 met primary · 2 missed | ||||||
| Phase 3 | NCT07747389 | Oct 2026 → Sep 2029 expected | major depressive disorder | Intra-Cellular Therapies, Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07623135 | Sep 2026 → Jun 2028 expected | major depressive disorder | Eric Lenze | Recruiting | No outcome recorded |
| Phase 3 | NCT06706674 | Dec 2024 → Jun 2027 expected | autism spectrum disorder | Intra-Cellular Therapies, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06690398 | Nov 2024 → Jun 2027 expected | autism spectrum disorder | Intra-Cellular Therapies, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06462612 | Jul 2024 → May 2026 overdue | manic bipolar affective disorder | Intra-Cellular Therapies, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06462586 | Jun 2024 → Mar 2026 overdue | manic bipolar affective disorder | Intra-Cellular Therapies, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06372964 | May 2024 → Oct 2031 expected | bipolar depression | Intra-Cellular Therapies, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06229210 | Jan 2024 → Apr 2032 expected | autism spectrum disorder, bipolar disorder, schizophrenia | Intra-Cellular Therapies, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05850689 | May 2023 → Apr 2027 expected | major depressive disorder | Intra-Cellular Therapies, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05061719 | Oct 2021 → Oct 2024 | major depressive disorder | Intra-Cellular Therapies, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05061706 | Sep 2021 → Apr 2024 | major depressive disorder | Intra-Cellular Therapies, Inc. | Completed | Met primary |
| Phase 3 | NCT04985942 | Jul 2021 → Feb 2024 | major depressive disorder | Intra-Cellular Therapies, Inc. | Completed | Met primary |
| Phase 3 | NCT04959032 | Jul 2021 → Jul 2024 | schizophrenia | Intra-Cellular Therapies, Inc. | Completed | Met primary |
| Phase 3 | NCT04285515 | Feb 2020 → Nov 2022 | bipolar depression, major depressive disorder | Intra-Cellular Therapies, Inc. | Completed | Met primary |
| Phase 3 | NCT03249376 | Nov 2017 → Mar 2019 | bipolar depression | Intra-Cellular Therapies, Inc. | Completed | Met primary |
| Phase 3 | NCT02817906 | Aug 2016 → Jan 2019 | — | Intra-Cellular Therapies, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT02600507 | Mar 2016 → Jul 2020 | bipolar depression | Intra-Cellular Therapies, Inc. | Completed | Met primary |
| Phase 3 | NCT02600494 | Dec 2015 → Jan 2019 | bipolar depression | Intra-Cellular Therapies, Inc. | Completed | Missed primary |
| Phase 3 | NCT02469155 | Jun 2015 → Aug 2016 | schizophrenia | Intra-Cellular Therapies, Inc. | Completed | Missed primary |
| Phase 3 | NCT02282761 | Nov 2014 → Jul 2015 | schizophrenia | Intra-Cellular Therapies, Inc. | Completed | Mixed |
| Phase 45 trials | ||||||
| Phase 4 | NCT07676669 | Dec 2026 → Mar 2027 expected | bipolar depression | Watim Medical & Dental College | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07799493 | Sep 2026 → May 2028 expected | social phobia | Jason Careri | Recruiting | No outcome recorded |
| Phase 4 | NCT07699445 | Sep 2026 → Jan 2028 expected | bipolar depression, obesity disorder | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06174116 | Apr 2024 → Dec 2026 expected | schizoaffective disorder, schizophrenia | University of Massachusetts, Worcester | Recruiting | No outcome recorded |
| Phase 4 | NCT05890768 | May 2023 → Feb 2024 | psychotic disorder | University of New Mexico | Withdrawn | No outcome recorded Stop: Enrollment |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT06482554 Comparator | Jun 2024 → Dec 2026 expected | schizophrenia | Louisiana State University Health Sciences Center Shreveport | Recruiting | No outcome recorded |
| Phase 4 | NCT07369115 Comparator | Feb 2026 → Jan 2030 expected | major depressive disorder | University of Texas at Austin | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-09-21 | Janssen Research & Development, LLC | Results CAPLYTA® (lumateperone) shows significant and rapid improvement in bipolar mania in pivotal Phase 3 study jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced positive topline results from the pivotal Phase 3 study evaluating CAPLYTA®(lumateperone) for the treatment of manic episodes with or without mixed features in adults with bipolar I disorder. |
| 2026-09-21 | Janssen Research & Development, LLC | Results CAPLYTA® (lumateperone) shows significant and rapid improvement in bipolar mania in pivotal Phase 3 study jnj.com ↗ |
| 2026-05-04 | Janssen Research & Development, LLC | Results CAPLYTA® (lumateperone) showed greatest improvement across key efficacy outcomes among adjunctive MDD treatments in new network meta-analysis jnj.com ↗
The NMA found that CAPLYTA®was favored for the efficacy outcomes across four measures, based on indirect comparisons derived from placebo plus antidepressant therapy (ADT)-controlled trials. |
| 2026-05-04 | Janssen Research & Development, LLC | Results CAPLYTA® (lumateperone) showed greatest improvement across key efficacy outcomes among adjunctive MDD treatments in new network meta-analysis jnj.com ↗ |
| 2026-04-27 | Janssen Research & Development, LLC | Regulatory FDA approves CAPLYTA® (lumateperone) sNDA with robust new data supporting reduced risk of relapse in schizophrenia jnj.com ↗
Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) based on long-term data evaluating the safety and efficacy of CAPLYTA®(lumateperone) for the prevention of relapse in schizophrenia. |
| 2026-04-27 | Janssen Research & Development, LLC | Regulatory FDA approves CAPLYTA® (lumateperone) sNDA with robust new data supporting reduced risk of relapse in schizophrenia jnj.com ↗
Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) based on long-term data evaluating the safety and efficacy of CAPLYTA® (lumateperone) for the prevention of relapse in schizophrenia. |
| 2026-01-16 | Janssen Research & Development, LLC | Results New clinical data highlights CAPLYTA® (lumateperone) as a promising option for achieving remission in adults with major depressive disorder jnj.com ↗
CAPLYTA®(lumateperone), in combination with an antidepressant, showed significantly greater remission rates in adults with major depressive disorder (MDD) than placebo plus an antidepressant at six weeks |
| 2026-01-16 | Janssen Research & Development, LLC | Results New clinical data highlights CAPLYTA® (lumateperone) as a promising option for achieving remission in adults with major depressive disorder jnj.com ↗
CAPLYTA® nearly doubled the likelihood of remission at six weeks compared to placebo as an adjunctive therapy to an antidepressant based on pooled data from two Phase 3 studies |
| 2025-11-06 | Janssen Research & Development, LLC | Regulatory FDA approval of CAPLYTA® (lumateperone) has the potential to reset treatment expectations, offering hope for remission in adults with major depressive disorder jnj.com ↗
Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved CAPLYTA®(lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. |
| 2025-11-06 | Janssen Research & Development, LLC | Regulatory FDA approval of CAPLYTA® (lumateperone) has the potential to reset treatment expectations, offering hope for remission in adults with major depressive disorder jnj.com ↗
Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved CAPLYTA (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. |
| 2025-07-08 | Janssen Research & Development, LLC | Regulatory Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo jnj.com ↗
Johnson & Johnson (NYSE:JNJ) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based upon long-term data evaluating the safety and efficacy of CAPLYTA®(lumateperone) for the prevention of relapse in schizophrenia. |
| 2025-07-08 | Janssen Research & Development, LLC | Regulatory Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo jnj.com ↗ |
All press releases naming this drug 12 releases
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 39 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lumateperone | “In the prespecified modified intent-to-treat efficacy analysis (n = 435), 42 mg of lumateperone met the primary and key secondary efficacy objectives, demonstrating a...” PMID 31913424 ↗ Apr 202030“Lumateperone for the Treatment of Schizophrenia: Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed.” PMID 36883881 ↗ Mar 2023 “40 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks” NCT02600494 ↗ “Lumateperone” NCT06482554 ↗ |
| Known as | Caplyta | “Lumateperone (Caplyta) 42 mg daily for adults with Social Anxiety Disorder” NCT07799493 ↗ |
| Known as | ITI-007 | “Adjunctive lumateperone (ITI-007) in the treatment of bipolar depression: Results from a randomized placebo-controlled clinical trial.” PMID 36779257 ↗ Feb 20237“Lumateperone 28 mg (ITI-007 40 mg Tosylate) administered orally as formulated capsules once daily for 28 days” NCT02282761 ↗ |
| Known as | ITI-007 tosylate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3306803 ↗ |
| Known as | ITI-722 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3306803 ↗ |
| Known as | Lumateperona | ChEMBL registry synonym — accepted as the source's own label CHEMBL3306803 ↗ |
| Known as | lumateperone tosylate | “INTERVENTIONS: Patients were randomized 1:1:1 (150 patients in each arm) to receive lumateperone tosylate, 60 mg; lumateperone tosylate, 40 mg (equivalent to 42 or 28 mg,...” PMID 31913424 ↗ Apr 2020 |
| Known as | X500-E2 | “Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection” NCT06627413 ↗ |
| Known as | X500-E3 | “Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection” NCT06627413 ↗ |
| Known as | X500-X2 | “Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection” NCT06627413 ↗ |
| Known as | X500-X5 | “Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection” NCT06627413 ↗ |
| Action | Inhibit | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL3306803 ↗ |
| Modality | Small molecule | — CHEMBL3306803 ↗ |
| Route | Oral | “Multiple Oral Dose Escalation” NCT02078310 ↗ |
| Target | DRD2 | “Dopamine D2 receptor antagonist” CHEMBL3306803 ↗ |
| Target | HTR2A | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL3306803 ↗ |
| Target | SLC6A4 | “Serotonin transporter inhibitor” CHEMBL3306803 ↗ |