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).
Background
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 |
|---|---|---|---|---|---|
2021/12/30 | Phase 4 | UNKNOWN | |||
2016/06/16 | Not Applicable | Completed | |||
2014/06/23 | Phase 4 | Completed | |||
2014/05/30 | Phase 3 | Terminated | |||
2013/04/16 | Not Applicable | Completed | |||
2012/08/03 | Phase 2 | Completed | |||
2011/03/11 | Phase 2 | Completed | |||
2010/06/28 | Phase 4 | Completed | Fahim Khorfan, MD | ||
2009/01/28 | Phase 4 | Withdrawn | |||
2009/01/28 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Dr. Reddys Laboratories, Inc. | 43598-412 | RESPIRATORY (INHALATION) | 0.31 mg in 3 mL | 9/16/2014 | |
| Akorn | 17478-173 | RESPIRATORY (INHALATION) | 0.63 mg in 3 mL | 6/30/2017 | |
| Amneal Pharmaceuticals of New York LLC | 0115-9931 | RESPIRATORY (INHALATION) | 0.63 mg in 3 mL | 6/29/2019 | |
| Ritedose Pharmaceuticals, LLC | 76204-700 | RESPIRATORY (INHALATION) | 0.31 mg in 3 mL | 12/20/2023 | |
| A-S Medication Solutions | 50090-6377 | RESPIRATORY (INHALATION) | 0.63 mg in 3 mL | 8/3/2022 | |
| NuCare Pharmaceuticals,Inc. | 68071-5027 | RESPIRATORY (INHALATION) | 1.25 mg in 3 mL | 2/19/2021 | |
| Mylan Pharmaceuticals Inc. | 0378-6993 | RESPIRATORY (INHALATION) | 1.25 mg in 0.5 mL | 8/29/2017 | |
| Sun Pharmaceutical Industries, Inc. | 47335-743 | RESPIRATORY (INHALATION) | 0.31 mg in 3 mL | 4/30/2020 | |
| Akorn | 17478-174 | RESPIRATORY (INHALATION) | 1.25 mg in 3 mL | 6/30/2017 | |
| 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 | 国药准字H20234008 | 化学药品 | 吸入制剂 | 8/1/2023 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20223069 | 化学药品 | 吸入制剂 | 1/30/2022 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20253376 | 化学药品 | 吸入制剂 | 2/11/2025 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20193279 | 化学药品 | 吸入制剂(吸入溶液) | 9/26/2019 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20253611 | 化学药品 | 吸入制剂 | 3/11/2025 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20253617 | 化学药品 | 吸入制剂 | 3/11/2025 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20253610 | 化学药品 | 吸入制剂 | 3/11/2025 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20253618 | 化学药品 | 吸入制剂 | 3/11/2025 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20253616 | 化学药品 | 吸入制剂 | 3/11/2025 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 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. | |||||