Loxapine

Generic Name: Loxapine

Brand Names: Adasuve, Xylac

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₁₈ClN_₃O

CAS Number: 1977-10-2

Unique Ingredient Identifier: LER583670J

Overview

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

Approved Product	Authorization Holder	Status	Issued Date
Adasuve	Ferrer Internacional S.A.,Gran Via Carlos III,94 E-08028 Barcelona,Spain	Authorised	2/20/2013

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
No NMPA approvals found for this drug.

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.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
LOXAPAC TAB 50MG	lederle cyanamid canada inc.	00346810	Tablet - Oral	68 MG / TAB	12/31/1976
LOXAPAC TAB 10MG	lederle cyanamid canada inc.	00346799	Tablet - Oral	13.6 MG / TAB	12/31/1975
LOXAPAC TAB 25MG	lederle cyanamid canada inc.	00346802	Tablet - Oral	34 MG / TAB	12/31/1975
LOXAPAC ORL CONC 25MG/ML	lederle cyanamid canada inc.	00361364	Liquid - Oral	25 MG / ML	12/31/1976
LOXAPAC INJ 50MG/ML	lederle cyanamid canada inc.	00439819	Liquid - Intramuscular	50 MG / ML	12/31/1980
LOXAPAC TAB 5MG	lederle cyanamid canada inc.	00346780	Tablet - Oral	6.8 MG / TAB	12/31/1976

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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