Clinical Trials

Numerous clinical trials spanning Phase I through Phase IV have evaluated the safety, pharmacokinetics, and therapeutic efficacy of loxapine succinate for schizophrenia, bipolar I disorder, psychomotor agitation, emergence delirium, and refractory chemotherapy-induced neuropathic pain. Conducted by both industry sponsors, such as Alexza Pharmaceuticals and Teva, and academic institutions, including Assistance Publique - Hôpitaux de Paris, these studies encompass completed, recruiting, terminated, and suspended recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05324852 TERMINATED
Emergence Delirium
Assistance Publique - Hôpitaux de Paris
 2023-04-09 PHASE3
NCT05324852 Recruiting
Emergence Delirium
Assistance Publique - Hôpitaux de Paris|Lariboisière-Saint Louis clinical research unit
 2023-04-14 Phase 3
NCT04148963 UNKNOWN
Psychomotor Agitation; Schizophrenia; Bipolar Disorder
Lee's Pharmaceutical Limited
 2019-12-01 PHASE3
NCT02525991 COMPLETED
Agitation
Ferrer Internacional S.A.
 2016-09-08 PHASE4
NCT03110900 TERMINATED
Agitation,Psychomotor; Haloperidol Causing Adverse Effects in Therapeutic Use; Lorazepam Causing Adverse Effects in Therapeutic Use; Loxapine Causing Adverse Effects in Therapeutic Use
University of Arkansas
 2017-09-30 PHASE4
NCT02820519 TERMINATED
Neuropathic Pain
University of Witten/Herdecke
 2016-06-07 PHASE2
NCT02820519 Terminated
Neuropathic Pain
University of Witten/Herdecke
 2016-06-07 Phase 2
NCT02184767 COMPLETED
BiPolar
Teva Branded Pharmaceutical Products R&D, Inc.
 2014-07 PHASE1
NCT01193816 COMPLETED
Restlessness
Assistance Publique - Hôpitaux de Paris
 2011-05 PHASE4
NCT01877642 COMPLETED
Healthy Volunteers
Alexza Pharmaceuticals, Inc.
 2013-06 PHASE4
NCT00890175 COMPLETED
Asthma
Alexza Pharmaceuticals, Inc.
 2009-05 PHASE1
NCT00889837 COMPLETED
Chronic Obstructive Pulmonary Disease
Alexza Pharmaceuticals, Inc.
 2009-06 PHASE1
NCT00825500 COMPLETED
Migraine Headache
Alexza Pharmaceuticals, Inc.
 2009-01 PHASE2
NCT00874237 COMPLETED
Thorough QT/QTc Study
Nova Pneuma Inc.
 2009-04 PHASE1
NCT00873769 COMPLETED
Smoking, Cigarette
Alexza Pharmaceuticals, Inc.
 2009-04 PHASE1
NCT00789360 COMPLETED
Healthy
Alexza Pharmaceuticals, Inc.
 2008-11 PHASE1
NCT00789360 Completed
Healthy
Alexza Pharmaceuticals Inc.
 2008-11 Phase 1
NCT00721955 COMPLETED
Bipolar I Disorder
Alexza Pharmaceuticals, Inc.
 2008-07 PHASE3
NCT00628589 COMPLETED
Patients With Schizophrenia and Acute Agitation
Alexza Pharmaceuticals, Inc.
 2008-02 PHASE3
NCT00489476 COMPLETED
Migraine
Alexza Pharmaceuticals, Inc.
 2007-06 PHASE2
NCT00555412 COMPLETED
Volunteers on Chronic, Stable Antipsychotic Regimens
Alexza Pharmaceuticals, Inc.
 2007-10 PHASE1
NCT00290082 TERMINATED
Acute Agitated Patients
University Hospital, Rouen
 2005-12 PHASE3
NCT00369577 COMPLETED
Schizophrenia
Alexza Pharmaceuticals, Inc.
 2006-08 PHASE2
NCT00444028 COMPLETED
Schizophrenia
Alexza Pharmaceuticals, Inc.
 2005-09 PHASE1
NCT00648778 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2003-01 PHASE1
NCT00122733 COMPLETED
Respiratory Insufficiency; Psychomotor Agitation
Assistance Publique - Hôpitaux de Paris
 2005-12

(data from https://clinicaltrials.gov, updated on 2024-05-28)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Loxapine succinate acts as a dibenzoxazepine antipsychotic by binding to and inhibiting dopamine D2 and D4 receptors while antagonizing serotonergic receptors, thereby blocking downstream G-protein-coupled signaling cascades and altering central neurotransmitter flux. This inhibition dampens hyperactive dopaminergic neurotransmission in limbic structures to suppress neuronal hyperexcitability, providing clinical efficacy in mitigating psychomotor agitation, schizophrenia, and bipolar disorder symptoms.

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>).

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