MedPath

Loxapine

Generic Name
Loxapine
Brand Names
Adasuve, Xylac
Drug Type
Small Molecule
Chemical Formula
C18H18ClN3O
CAS Number
1977-10-2
Unique Ingredient Identifier
LER583670J

Overview

An antipsychotic agent used in schizophrenia. [PubChem]

Background

An antipsychotic agent used in schizophrenia. [PubChem]

Indication

For the management of the manifestations of psychotic disorders such as schizophrenia

Associated Conditions

  • Acute Agitation
  • Schizophrenia

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine
2022/04/12
NCT05324852
Phase 3
Terminated
Assistance Publique - Hôpitaux de Paris
A Study of Staccato Loxapine (ADASUVE®) for Inhalation
2019/11/04
NCT04148963
Phase 3
UNKNOWN
Lee's Pharmaceutical Limited
Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder
2018/05/01
NCT03513549
N/A
UNKNOWN
Alexza Pharmaceuticals, Inc.
Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation
2017/04/12
NCT03110900
Phase 4
Terminated
University of Arkansas
Tolerability and Analgesic Efficacy of Loxapine in Patients With Refractory, Chemotherapy-induced Neuropathic Pain
2016/07/01
NCT02820519
Phase 2
Terminated
University of Witten/Herdecke
Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)
2015/11/09
NCT02600741
N/A
Completed
Janssen Scientific Affairs, LLC
Outcomes of Antipsychotic Medication Used in the Emergency Department
2015/07/22
NCT02504450
N/A
Completed
Wake Forest University Health Sciences
Study to Assess the Safety and Pharmacokinetics of ADASUVE® at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication
2014/07/09
NCT02184767
Phase 1
Completed
Teva Branded Pharmaceutical Products R&D, Inc.
ADASUVE-Lorazepam Drug-Drug Interaction
2013/06/14
NCT01877642
Phase 4
Completed
Alexza Pharmaceuticals, Inc.
ADASUVE 2-dose Thorough QT/QTc Study
2013/05/15
NCT01854710
Phase 4
Completed
Alexza Pharmaceuticals, Inc.

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Loxapine
Actavis Pharma, Inc.
0591-0370
ORAL
10 mg in 1 1
12/30/2016
Loxapine
Chartwell RX, LLC
62135-493
ORAL
10 mg in 1 1
3/1/2023
Loxapine
Marlex Pharmaceuticals Inc
10135-586
ORAL
10 mg in 1 1
2/10/2016
Loxapine
Marlex Pharmaceuticals Inc
10135-587
ORAL
25 mg in 1 1
2/10/2016
Loxapine
ATLANTIC BIOLOGICALS CORP.
17856-1397
ORAL
50 mg in 1 1
8/5/2020
Loxapine
Lannett Company, Inc.
0527-1397
ORAL
50 mg in 1 1
5/28/2020
Loxapine
Elite Laboratories, Inc.
64850-893
ORAL
50 mg in 1 1
12/20/2022
Adasuve
Alexza Pharmaceuticals, Inc.
51097-001
RESPIRATORY (INHALATION)
10 mg in 1 1
1/9/2024
Loxapine
Burel Pharmaceuticals, LLC
35573-437
ORAL
10 mg in 1 1
9/7/2021
Loxapine
Proficient Rx LP
82804-051
ORAL
5 mg in 1 1
12/1/2023

EMA Drug Approvals

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Loxapine for Inhalation
FERRER INTERNACIONAL SA
国药准字HJ20230129
化学药品
吸入制剂
11/21/2023
Loxapine Succinate Capsules
瀚晖制药有限公司
国药准字H20056302
化学药品
胶囊剂
5/22/2020
Loxapine Succinate Capsules
瀚晖制药有限公司
国药准字H10980276
化学药品
胶囊剂
5/22/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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