Clinical Trials

Asenapine maleate has been evaluated across Phase I through Phase IV in numerous clinical trials investigating its therapeutic utility in psychiatric conditions—including schizophrenia, bipolar I disorder, and major depressive disorder—alongside exploratory indications like stuttering. Sponsored by major pharmaceutical corporations and academic institutions, these studies encompass completed evaluations, such as comparative efficacy and open-label switch protocols, as well as active, suspended, terminated, and unknown statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07047651 ACTIVE_NOT_RECRUITING
Treatment Resistant Schizophrenia; Treatment Resistant Bipolar Disorder
Dr. Stavroula Rakitzi
 2025-06-04 PHASE4
NCT02876900 COMPLETED
Schizophrenia
Noven Pharmaceuticals, Inc.
 2016-08 PHASE3
NCT01807741 TERMINATED
Bipolar Depression
University of Cincinnati
 2013-09 PHASE2
NCT01587118 COMPLETED
Posttraumatic Stress Disorder
Lori Davis, MD
 2012-06 PHASE4
NCT01142596 COMPLETED
Schizophrenia
Organon and Co
 2010-05-25 PHASE3
NCT01396291 COMPLETED
Bipolar 1 Disorder
Forest Laboratories
 2011-12 PHASE3
NCT01617200 COMPLETED
Schizophrenia
Forest Laboratories
 2012-12 PHASE3
NCT01395992 COMPLETED
Bipolar I Disorder
Forest Laboratories
 2012-04 PHASE3
NCT01349907 COMPLETED
Bipolar Disorder
Organon and Co
 2011-06-16 PHASE3
NCT01244828 COMPLETED
Schizophrenia
Organon and Co
 2011-04-05 PHASE3
NCT01617187 COMPLETED
Schizophrenia
Organon and Co
 2012-12-04 PHASE3
NCT01670019 COMPLETED
Major Depressive Disorder Without Psychotic Features
Duke University
 2012-10 PHASE4
NCT01684657 SUSPENDED
Stuttering
University of California, Irvine
 2012-09 PHASE3
NCT00764478 COMPLETED
Bipolar 1 Disorder
Organon and Co
 2012-04-06 PHASE3
NCT01098110 COMPLETED
Schizophrenia
Organon and Co
 2010-05-25 PHASE3
NCT01460290 COMPLETED
Bipolar Disorder
University Hospitals Cleveland Medical Center
 2011-10 PHASE4
NCT00806234 COMPLETED
Psychotic Disorders
Johns Hopkins University
 2009-01 PHASE4
NCT02072954 COMPLETED
Schizophrenia
Amneal Pharmaceuticals, LLC
 2013-11 PHASE2; PHASE3
NCT01968161 UNKNOWN
Schizophrenia and Disorders With Psychotic Features; Disorders
Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
 2013-10 PHASE4
NCT01190267 COMPLETED
Schizophrenia, Paranoid; Schizophrenia, Disorganized; Schizophrenia, Undifferentiated
Organon and Co
 2010-09-28 PHASE3
NCT01968161 Unknown status
Schizophrenia and Disorders With Psychotic Features|Disorders
Centre de Recherche de l''Institut Universitaire en Santé Mentale de Québec
 2013-10 Phase 4
NCT01244815 COMPLETED
Bipolar Disorder, Pediatric
Organon and Co
 2011-06-16 PHASE3
NCT01948024 COMPLETED
Schizophrenia; Bipolar Disorder
Sun Pharmaceutical Industries Limited
 2013-07 PHASE1
NCT01549041 COMPLETED
Schizophrenia
Duke University
 2012-04 PHASE4
NCT01190254 COMPLETED
Schizophrenia, Paranoid; Schizophrenia, Disorganized; Schizophrenia, Undifferentiated
Organon and Co
 2010-09-28 PHASE3
NCT01400113 COMPLETED
Agitation
Unity Health Toronto
 2012-04 PHASE4
NCT01734278 Completed
Manic Disorder
Professor Saad Shakir|Merck Sharp & Dohme LLC|Drug Safety Research Unit Southampton UK
 2012-10 --
NCT01206517 COMPLETED
Schizophrenia; Bipolar I Disorder
Organon and Co
 2010-07-18 PHASE1
NCT00174265 COMPLETED
Schizophrenia
Organon and Co
 2005-07 PHASE3
NCT00281320 COMPLETED
Psychosis
Organon and Co
 2006-02 PHASE3
NCT00145496 COMPLETED
Schizophrenia
Organon and Co
 2004-12 PHASE3
NCT00150176 COMPLETED
Schizophrenia
Organon and Co
 2005-04 PHASE3
NCT00265343 COMPLETED
Schizophrenia
Organon and Co
 2005-12 PHASE3
NCT00145509 COMPLETED
Bipolar Disorder
Organon and Co
 2005-08 PHASE3
NCT00156065 COMPLETED
Schizophrenia
Organon and Co
 2005-09 PHASE3
NCT00212836 COMPLETED
Schizophrenia
Organon and Co
 2005-04-21 PHASE3
NCT00156091 COMPLETED
Schizophrenia
Organon and Co
 2005-04 PHASE3
NCT00159783 COMPLETED
Bipolar Disorder
Organon and Co
 2005-07 PHASE3
NCT00145470 COMPLETED
Bipolar Disorder
Organon and Co
 2005-06-02 PHASE3
NCT00212771 COMPLETED
Schizophrenia; Schizoaffective Disorder
Organon and Co
 2004-09 PHASE3
NCT00156104 COMPLETED
Schizophrenia
Organon and Co
 2005-07-01 PHASE3
NCT00143182 COMPLETED
Bipolar Disorder
Organon and Co
 2005-01-07 PHASE3
NCT00159744 COMPLETED
Bipolar Disorder
Organon and Co
 2004-11-30 PHASE3
NCT00156117 COMPLETED
Schizophrenia
Organon and Co
 2005-05-12 PHASE3
NCT00159796 COMPLETED
Bipolar Disorder
Organon and Co
 2004-12-14 PHASE3
NCT00212784 COMPLETED
Schizophrenia; Schizoaffective Disorder
Organon and Co
 2003-09-04 PHASE3
NCT00281320 Completed
Psychosis
Organon and Co
 2006-02 Phase 3
NCT00151424 COMPLETED
Schizophrenia
Organon and Co
 2005-02-15 PHASE3
NCT00878462 COMPLETED
Psychosis
Organon and Co
 2005-06-29 PHASE2
NCT01101464 COMPLETED
Schizophrenia; Schizoaffective Disorder
Organon and Co
 2002-10 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-05-01)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Asenapine maleate functions as a multi-target antagonist with high affinity for serotonin (such as 5-HT2A and 5-HT2C), dopamine (D2 and D3), adrenergic, and histamine H1 receptors, thereby blocking downstream monoaminergic receptor-mediated signaling pathways. This receptor blockade alters postsynaptic neurotransmission within central nervous system circuits, ultimately attenuating psychotic and manic symptoms in clinical conditions such as schizophrenia and bipolar 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.