Clinical Trials

Lumateperone tosylate is evaluated across Phase I through IV clinical trials sponsored by corporate entities such as Intra-Cellular Therapies, Inc., alongside academic and institutional investigators. Primary research targets psychiatric conditions—including major depressive disorder, treatment-resistant depression, bipolar depression, schizophrenia, psychosis, and apathy—as well as exploratory indications like adult stuttering and autism spectrum disorder. Spanning actively recruiting, completed, terminated, and withdrawn statuses, these numerous clinical trials include completed Phase III studies assessing adjunctive therapy in major depressive disorder.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06229210 RECRUITING
Schizophrenia; Bipolar Disorder; Autism Spectrum Disorder
Intra-Cellular Therapies, Inc.
 2024-01-25 PHASE3
NCT06372964 RECRUITING
Bipolar Depression
Intra-Cellular Therapies, Inc.
 2024-05-14 PHASE3
NCT07369115 NOT_YET_RECRUITING
Major Depressive Diorder; Early Life Trauma
University of Texas at Austin
 2026-02 PHASE4
NCT07747389 NOT_YET_RECRUITING
Depressive Disorder, Major
Intra-Cellular Therapies, Inc.
 2026-10-20 PHASE3
NCT07623135 RECRUITING
Treatment Resistant Depression (TRD); Late Life Depression (LLD); Depression / Major Depressive Disorder
Eric Lenze
 2026-08 PHASE3
NCT07799493 NOT_YET_RECRUITING
Social Anxiety Disorder (SAD)
Jason Careri
 2026-08-18 PHASE4
NCT07699445 NOT_YET_RECRUITING
Bipolar Depression Depressed Phase; Obesity & Overweight
Massachusetts General Hospital
 2026-07-31 PHASE4
NCT07734103 RECRUITING
Stuttering, Adult
CSTrials Inc.
 2026-04-18 PHASE2
NCT06706674 RECRUITING
Irritability Associated With Autism Spectrum Disorder
Intra-Cellular Therapies, Inc.
 2024-12-06 PHASE3
NCT06690398 RECRUITING
Irritability Associated With Autism Spectrum Disorder
Intra-Cellular Therapies, Inc.
 2024-11-22 PHASE3
NCT05850689 RECRUITING
Major Depressive Disorder
Intra-Cellular Therapies, Inc.
 2023-05-02 PHASE3
NCT07676669 NOT_YET_RECRUITING
Bipolar 1 Depression
Watim Medical & Dental College
 2026-12 PHASE4
NCT06482554 RECRUITING
Apathy; Schizophrenia; Schizophrenia; Psychosis
Louisiana State University Health Sciences Center Shreveport
 2024-06 PHASE3
NCT06174116 RECRUITING
Schizophrenia; Schizo Affective Disorder
University of Massachusetts, Worcester
 2024-04-02 PHASE4
NCT06462612 COMPLETED
Bipolar Disorder, Manic
Intra-Cellular Therapies, Inc.
 2024-07-17 PHASE3
NCT06462586 COMPLETED
Bipolar Disorder, Manic
Intra-Cellular Therapies, Inc.
 2024-06-19 PHASE3
NCT06557902 COMPLETED
Autism Spectrum Disorder
Intra-Cellular Therapies, Inc.
 2024-05-10 PHASE1
NCT06627413 COMPLETED
Schizophrenia or Schizoaffective
Intra-Cellular Therapies, Inc.
 2024-08-23 PHASE1
NCT05061719 COMPLETED
Major Depressive Disorder
Intra-Cellular Therapies, Inc.
 2021-10-08 PHASE3
NCT04959032 COMPLETED
Schizophrenia
Intra-Cellular Therapies, Inc.
 2021-07-08 PHASE3
NCT05061706 COMPLETED
Major Depressive Disorder
Intra-Cellular Therapies, Inc.
 2021-09-30 PHASE3
NCT05890768 WITHDRAWN
Psychosis
University of New Mexico
 2023-05-11 PHASE4
NCT04985942 COMPLETED
Major Depressive Disorder
Intra-Cellular Therapies, Inc.
 2021-07-30 PHASE3
NCT04285515 COMPLETED
Bipolar Depression; Major Depressive Disorder
Intra-Cellular Therapies, Inc.
 2020-02-27 PHASE3
NCT04779177 COMPLETED
Schizophrenia; Pediatric
Intra-Cellular Therapies, Inc.
 2021-03-12 PHASE1
NCT04709224 COMPLETED
Schizophrenia
Intra-Cellular Therapies, Inc.
 2020-12-30 PHASE1
NCT03817528 TERMINATED
Schizophrenia
New York State Psychiatric Institute
 2019-03-01 PHASE2
NCT02600507 COMPLETED
Bipolar Depression
Intra-Cellular Therapies, Inc.
 2016-03-07 PHASE3
NCT03249376 COMPLETED
Bipolar Depression
Intra-Cellular Therapies, Inc.
 2017-11-27 PHASE3
NCT02600494 COMPLETED
Bipolar Depression
Intra-Cellular Therapies, Inc.
 2015-12-15 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-28)

Check the Lumateperone Tosylate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lumateperone tosylate acts as a potent 5-HT2A receptor antagonist, postsynaptic D2 receptor antagonist, presynaptic D2 partial agonist, and dopamine D1 modulator, thereby regulating monoaminergic neurotransmission and downstream intracellular signaling cascades in cortical and subcortical neuronal circuits. This multi-target receptor modulation restores balanced dopaminergic and serotonergic signaling within central neural pathways, mitigating the neurobiological dysfunction associated with clinical conditions such as schizophrenia, bipolar depression, and major depressive disorder.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.