Levosalbutamol

Overview

Levosalbutamol, or levalbuterol, is a short-acting β2 adrenergic receptor agonist used in the treatment of asthma and chronic obstructive pulmonary disease (COPD). Salbutamol has been marketed as a racemic mixture, although beta2-agonist activity resides almost exclusively in the (R)-enantiomer. The enantioselective disposition of salbutamol and the possibility that (S)-salbutamol has adverse effects have led to the development of an enantiomerically pure (R)-salbutamol formulation known as levosalbutamol (levalbuterol).

Indication

Indicated for the management of COPD (chronic obstructive pulmonary disease, also known as chronic obstructive lung disease) and asthma.

Associated Conditions

Bronchospasm

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Levalbuterol Compared to Albuterol Regarding Cardiac Side Effects and Potassium Lowering Effects.	2021/12/30	NCT05173584	Phase 4	UNKNOWN	University of Aleppo
Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults	2016/06/16	NCT02802111	Not Applicable	Completed	Children's Hospital Los Angeles
Aerosolized Beta-Agonist Isomers in Asthma	2014/06/23	NCT02170532	Phase 4	Completed	Duke University
A Study of Levalbuterol Tartrate HFA Inhalation Aerosol Metered Dose Inhaler (MDI) in Pediatric Subjects	2014/05/30	NCT02150499	Phase 3	Terminated	Sumitomo Pharma America, Inc.
COPD Assessment and Management Bundle Versus Usual Care	2013/04/16	NCT01833026	Not Applicable	Completed	University of Illinois at Chicago
A Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma	2012/08/03	NCT01656811	Phase 2	Completed	Sumitomo Pharma America, Inc.
Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma	2011/03/11	NCT01312961	Phase 2	Completed	Sanofi
Effect of Nebulized Bronchodilators on Heart Rate	2010/06/28	NCT01151579	Phase 4	Completed	Fahim Khorfan, MD
Peak Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol	2009/01/28	NCT00830882	Phase 4	Withdrawn	University of Dundee
Trough Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol	2009/01/28	NCT00831376	Phase 4	Completed	University of Dundee

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
levalbuterol inhalation	Dr. Reddys Laboratories, Inc.	43598-412	RESPIRATORY (INHALATION)	0.31 mg in 3 mL	9/16/2014
Xopenex	Akorn	17478-173	RESPIRATORY (INHALATION)	0.63 mg in 3 mL	6/30/2017
Levalbuterol	Amneal Pharmaceuticals of New York LLC	0115-9931	RESPIRATORY (INHALATION)	0.63 mg in 3 mL	6/29/2019
Levalbuterol	Ritedose Pharmaceuticals, LLC	76204-700	RESPIRATORY (INHALATION)	0.31 mg in 3 mL	12/20/2023
Levalbuterol	A-S Medication Solutions	50090-6377	RESPIRATORY (INHALATION)	0.63 mg in 3 mL	8/3/2022
Levalbuterol	NuCare Pharmaceuticals,Inc.	68071-5027	RESPIRATORY (INHALATION)	1.25 mg in 3 mL	2/19/2021
Levalbuterol	Mylan Pharmaceuticals Inc.	0378-6993	RESPIRATORY (INHALATION)	1.25 mg in 0.5 mL	8/29/2017
Levalbuterol Inhalation Solution	Sun Pharmaceutical Industries, Inc.	47335-743	RESPIRATORY (INHALATION)	0.31 mg in 3 mL	4/30/2020
Xopenex	Akorn	17478-174	RESPIRATORY (INHALATION)	1.25 mg in 3 mL	6/30/2017
Levalbuterol	Burel Pharmaceuticals, LLC	35573-443	RESPIRATORY (INHALATION)	0.31 mg in 3 mL	7/1/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

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
Levosalbutamol Hydrochloride Nebuliser Solution	湖南科伦制药有限公司	国药准字H20234008	化学药品	吸入制剂	8/1/2023
Levosalbutamol Hydrochloride Nebuliser Solution	太阳升（亳州）生物医药科技有限公司	国药准字H20223069	化学药品	吸入制剂	1/30/2022
Levosalbutamol Hydrochloride Nebuliser Solution	山东京卫制药有限公司	国药准字H20253376	化学药品	吸入制剂	2/11/2025
Levosalbutamol Hydrochloride Nebuliser Solution	健康元药业集团股份有限公司	国药准字H20193279	化学药品	吸入制剂(吸入溶液)	9/26/2019
Levosalbutamol Hydrochloride Nebuliser Solution	山西阳和医药技术有限公司	国药准字H20253611	化学药品	吸入制剂	3/11/2025
Levosalbutamol Hydrochloride Nebuliser Solution	罗欣安若维他药业（成都）有限公司	国药准字H20253617	化学药品	吸入制剂	3/11/2025
Levosalbutamol Hydrochloride Nebuliser Solution	山西阳和医药技术有限公司	国药准字H20253610	化学药品	吸入制剂	3/11/2025
Levosalbutamol Hydrochloride Nebuliser Solution	罗欣安若维他药业（成都）有限公司	国药准字H20253618	化学药品	吸入制剂	3/11/2025
Levosalbutamol Hydrochloride Nebuliser Solution	罗欣安若维他药业（成都）有限公司	国药准字H20253616	化学药品	吸入制剂	3/11/2025
Levosalbutamol Hydrochloride Nebuliser Solution	浙江恒研医药科技有限公司	国药准字H20243408	化学药品	吸入制剂	3/29/2024

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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