albuterol
Trade name: proventil
Approved
May 1, 1981
Albuterol is a short acting beta2-adrenergic receptor agonist. Albuterol effectively alleviates bronchospasm due to bronchial asthma, chronic bronchitis, and other chronic bronchopulmonary disorders such as COPD. In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta2-adrenergic receptors compared with isoproterenol. While it is recognized that beta2-adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta2-receptors in the human heart existing in a concentration between 10% and 50%. The precise function of these receptors has not been established. The pharmacologic effects of beta-adrenergic agonist drugs, including albuterol, are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'- adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects. Albuterol is longer acting than isoproterenol in most patients by any route of administration because it is not a substrate for the cellular uptake processes for catecholamines nor for catechol-O-methyl transferase. — NCATS
Clinical trial activity
419 trials · 289 clinical orgs · 62 marketing orgs
Earliest trial started Jul 1, 1993 (NCT00940927)
Timeline
1980s
- May 1, 1981
Schering-Plough — Earliest FDA Approval
- May 1, 1981
GlaxoSmithKline — NDA Secondary Org
- May 1, 1981
Schering-Plough — NDA Organization
- May 1, 1981
Schering — NDA Secondary Org
- Jan 30, 1989
Pliva — Marketing Organization
- Apr 7, 1989
Teva — Marketing Organization
- Dec 20, 1989
Strides Pharma Science — Marketing Organization
- Dec 20, 1989
DAVA Pharmaceuticals — Marketing Organization
1990s
- Jan 17, 1991
Mylan — Marketing Organization
- Jan 17, 1991
Dash Pharms — Marketing Organization
- Jan 31, 1991
Watson Pharmaceuticals — Marketing Organization
- Dec 23, 1992
Muro Pharmaceuticals — NDA Secondary Org
- Jan 1, 1993
Earliest Phase 3 Sponsor(trial)
- Sep 30, 1994
Mova — Marketing Organization
- Sep 25, 1995
G & W Laboratories Inc. — Marketing Organization
- Sep 25, 1995
Cosette — Marketing Organization
- Sep 26, 1995
Actavis — Marketing Organization
- Aug 14, 1996
Armstrong Pharmaceuticals — Marketing Organization
- Aug 15, 1996
3M — NDA Secondary Org
- Aug 15, 1996
Kindeva — Marketing Organization
- Aug 15, 1996
Kindeva — NDA Secondary Org
- Oct 24, 1996
Boehringer Ingelheim — Marketing Organization
- Oct 24, 1996
Boehringer Ingelheim — NDA Secondary Org
- Aug 19, 1997
Genpharm — Marketing Organization
- Aug 19, 1997
Medarex — Marketing Organization
- Sep 17, 1997
Nephron Pharmaceuticals Corporation — Marketing Organization
- Jan 15, 1998
Hi Tech Pharmaceuticals — Marketing Organization
- Jan 15, 1998
Akorn, Inc. — Marketing Organization
- Jan 15, 1998
SENTISS — Marketing Organization
- Jan 30, 1998
Hikma — Marketing Organization
- Jun 18, 1998
Bausch Health Companies — Marketing Organization
- Jun 18, 1998
Bausch & Lomb — Marketing Organization
- Jan 1, 1999
Boehringer Ingelheim — Earliest Phase 1 Sponsor(trial)
- Feb 9, 1999
Epic Pharma Llc — Marketing Organization
- Nov 22, 1999
Wockhardt — Marketing Organization
2000s
- Jan 1, 2000
Boehringer Ingelheim — Earliest Phase 2 Sponsor(trial)
- Feb 13, 2001
Roxane Laboratories — Marketing Organization
- Mar 21, 2001
Mylan — NDA Secondary Org
- Apr 1, 2003
Apotex — Marketing Organization
- Oct 29, 2004
Teva — NDA Secondary Org
- Apr 4, 2006
Landela Pharmaceutical — Marketing Organization
- Dec 21, 2006
Fosun — Marketing Organization
- Dec 27, 2006
Lannett Company, Inc. — Marketing Organization
- Jun 26, 2007
Chartwell Pharmaceuticals — Marketing Organization
- Jun 26, 2007
VistaPharm, Inc. — Marketing Organization
- Dec 31, 2007
Cipla — Marketing Organization
- Dec 16, 2008
Ritedose — Marketing Organization
2010s
- May 12, 2010
Amneal Pharmaceuticals — Marketing Organization
- Jul 21, 2017
Sun Pharmaceuticals — Marketing Organization
- Oct 17, 2017
Aurobindo Pharma — Marketing Organization
- Oct 17, 2017
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. — Marketing Organization
- Jun 29, 2018
Appco Pharma — Marketing Organization
- Jun 29, 2018
Rising Pharmaceuticals — Marketing Organization
- Oct 26, 2018
Virtus Pharms — Marketing Organization
- Mar 15, 2019
Arise Pharmaceuticals — Marketing Organization
- Mar 15, 2019
Aizant — Marketing Organization
- Sep 6, 2019
Quagen Pharma — Marketing Organization
2020s
- Feb 24, 2020
Perrigo — Marketing Organization
- Feb 24, 2020
Padagis Us — Marketing Organization
- Aug 24, 2020
Lupin — Marketing Organization
- Oct 8, 2020
Eywa Pharma — Marketing Organization
- Oct 22, 2020
Zydus Discovery DMCC — Marketing Organization
- Jun 1, 2021
Sandoz — Marketing Organization
- Jun 1, 2021
Novartis — Marketing Organization
- Dec 28, 2021
Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization
- Jan 10, 2023
AstraZeneca — NDA Secondary Org
Indications
Approved for
Studied for
- Airway Management · Phase 4
- Airway Obstruction · Phase 4
- Airway Remodeling · Phase 3
- Albuterol · Phase 4
- Amyotrophic Lateral Sclerosis · Phase 2
- Anaphylaxis · Phase 4
- Anemia, Sickle Cell · Phase 1
- Anti-Asthmatic Agents · Phase 3
- Asthma · Phase 4
- Asthma, Exercise-Induced · Phase 4
- Autonomic Nervous System Diseases · Phase 3
- Bipolar Disorder · Phase 3
- Brain Death · Phase 2
- Bronchial Spasm · Phase 3
- Bronchiolitis · Phase 4
- Bronchiolitis Obliterans · Phase 3
- Bronchiolitis, Viral · Phase 2
- Bronchitis · Phase 4
- Bronchoconstriction · Phase 4
- Bronchodilator Agents · Phase 3
- Bronchopulmonary Dysplasia · Phase 4
- Cannula · Phase 3
- Cesarean Section · Phase 4
- Child · Phase 4
- Cicatrix · Phase 1
- Ciliary Motility Disorders · Phase 1
- Conjunctivitis · Phase 3
- Cough · Phase 2
- Diabetes Mellitus · Phase 1
- Diabetes Mellitus, Type 1 · Phase 1
- Drug Evaluation · Phase 2
- Dysautonomia, Familial · Phase 3
- Epinephrine · Phase 4
- Exercise · Phase 4
- Familial Primary Pulmonary Hypertension · Phase 2
- Fasting · Phase 1
- Food Hypersensitivity · Phase 4
- Glycogen Storage Disease Type II · Phase 4
- Healthy Volunteers · Phase 4
- Heart Diseases · Phase 4
- Heart Failure · Phase 3
- Heart Septal Defects, Ventricular · Phase 4
- Hyperkalemia · Phase 4
- Hypersensitivity · Phase 3
- Hypertension, Pulmonary · Early Phase 1
- Idiopathic Pulmonary Fibrosis · Phase 1
- Immune System Diseases · Early Phase 1
- Infant, Very Low Birth Weight · Phase 4
- Inflammation · Phase 4
- Inhalation · Phase 4
- Ligaments, Articular · Phase 1
- Lung Diseases · Phase 4
- Lung Diseases, Obstructive · Phase 4
- Lymphangioleiomyomatosis · Phase 2
- Major Depressive Disorder · Phase 1
- Memory Disorders · Phase 2
- Migraine Disorders · Phase 3
- Mucociliary Clearance · Phase 4
- Myasthenia Gravis · Phase 2/Phase 3
- Myasthenic Syndromes, Congenital · Phase 1
- Nausea · Phase 2
- Neuralgia, Postherpetic · Phase 3
- Nicotiana · Phase 4
- Obesity · Early Phase 1
- Organophosphate Poisoning · Phase 3
- Ozone · Phase 4
- Pain · Phase 3
- Pancreatitis · Phase 2
- Pediatric Obesity · Phase 4
- Pharmacokinetics · Phase 4
- Pneumonia · Phase 2/Phase 3
- Postural Balance · Phase 4
- Pulmonary Arterial Hypertension · Phase 3
- Pulmonary Disease, Chronic Obstructive · Phase 4
- Pulmonary Edema · Phase 2
- Renal Colic · Phase 3
- Respiratory Distress Syndrome · Phase 2/Phase 3
- Respiratory Insufficiency · Phase 3
- Respiratory Sounds · Phase 4
- Respiratory Syncytial Virus Infections · Phase 4
- Rhinitis · Phase 3
- Rhinitis, Allergic, Seasonal · Phase 4
- Safety · Phase 2
- Sepsis · Phase 4
- Shock · Phase 4
- Signs and Symptoms, Respiratory · Phase 4
- Sleep Apnea, Obstructive · Phase 4
- Status Asthmaticus · Phase 4
- Tissue Donors · Phase 2
- Tobacco Smoke Pollution · Phase 4
- Tonsillectomy · Phase 4
- Transient Tachypnea of the Newborn · Phase 1
- Venous Cutdown · Phase 4
- Ventilation · Phase 4
- Viruses · Phase 4
- Vomiting · Phase 3
- Walking · Phase 2
- Water-Electrolyte Balance · Phase 4
Mechanism of action
- Beta-2 adrenergic receptorAGONIST
ADRB2 agonist
Combination products
airsupra
with budesonide
combivent
with ipratropium
Also known as combivent respimat, duoneb
Approval history
- approvedPriority reviewMay 1, 1981
Chemistry & pharmacology
SMILES
CC(C)(C)NCC(O)c1ccc(O)c(CO)c1- Mol. weight
- 239.31 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Topical
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
Yes
Sources
- ChEMBLCHEMBL714 ↗
- WikipediaSalbutamol ↗
- NCATSQF8SVZ843E ↗
- ChEMBLCHEMBL1201026 ↗
Also known as
- accuneb
- accuneb
- aerolin
- aerolin
- aerolin 400
- aerolin auto
- airomir
- airomir
- airsalb
- albuterol
- albuterol
- albuterol
- albuterol
- albuterol
- albuterol
- albuterol
- albuterol sulfate
- albuterol sulfate
- albuterol sulfate
- albuterol sulfate
- albuterol sulfate
- albuterol sulfate mixture with ipratropium bromide
- asmasal clickhaler
- asmasal spacehaler
- asmaven
- asmaven
- asmavent
- cobutolin
- cobutolin
- combivent
- combivent
- combivent udvs
- dl-albuterol
- dl-salbutamol
- duoneb
- ipramol steri-neb
- kentamol
- libetist
- maxivent
- maxivent
- proair hfa
- proair hfa
- proventil
- proventil
- proventil
- proventil
- proventil hfa
- proventil hfa
- proventil-hfa
- proventil-hfa
- rimasal
- sabumol
- salamol e-breathe
- salapin
- salbulin novolizer
- salbutamol
- salbutamol
- salbutamol
- salbutamol
- salbutamol
- salbutamol
- salbutamol
- salbutamol
- salbutamol
- (+-)-salbutamol sulfate
- salbutamol sulfate
- salbutamol sulfate
- salbutamol sulphate
- salbutamol sulphate
- salbuvent
- salbuvent
- salipraneb
- salubatmol
- sch-13949w
- sch-13949w
- sch-13949w sulfate
- sch-13949w sulfate
- steri-neb salamol
- ventmax sr
- ventodisks
- ventodisks
- ventolin
- ventolin
- ventolin
- ventolin cr
- ventoline
- ventoline
- ventolin e-breathe
- ventolin hfa
- ventolin hfa
- ventolin rotacaps
- ventolin rotacaps
- volmax
- volmax
- vospire
- vospire
- vospire er
- vospire er
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07037511 | N/A | Jun 30, 2025 | University of British Columbia |
| NCT06980727 | Phase 3 | Jun 1, 2025 | University of Monastir |
| NCT06815679 | Phase 2/Phase 3 (Phase 3) | Mar 1, 2025 | Aerogen, University of Ferrara |
| NCT06644924 | Phase 2 | Jan 6, 2025 | AstraZeneca |
| NCT06664619 | Phase 3 | Nov 7, 2024 | Teva |
| NCT06426082 | N/A | Nov 1, 2024 | Leiden University, Universidad de Almeria, University of Zurich |
| NCT06816342 | Phase 4 | Nov 1, 2024 | Beni Suef University |
| NCT06618105 | Phase 3 | Oct 15, 2024 | Macleods Pharmaceuticals, Ltd |
| NCT06473779 | Phase 3 | Sep 30, 2024 | AstraZeneca, Fortrea |
| NCT06563102 | Phase 4 | Sep 11, 2024 | AstraZeneca, Fortrea |
| NCT06158893 | Phase 4 | Aug 31, 2024 | Assiut University |
| NCT06514157 | Phase 1 | Aug 19, 2024 | AstraZeneca |
| NCT06433921 | Phase 1 | Aug 14, 2024 | GlaxoSmithKline |
| NCT06921291 | Phase 1 | Aug 1, 2024 | Khyber Medical University Peshawer |
| NCT06502366 | Phase 3 | Jul 22, 2024 | AstraZeneca |
| NCT06276231 | N/A | Jul 1, 2024 | Government of Oman, Oman Medical Board Specialty (OMSB) |
| NCT06482294 | Phase 2 | Jun 18, 2024 | University of Ferrara |
| NCT06471257 | Phase 3 | Jun 17, 2024 | AstraZeneca |
| NCT06433908 | Phase 1 | Jun 4, 2024 | GlaxoSmithKline |
| NCT06261957 | Phase 3 | May 31, 2024 | GlaxoSmithKline |
Organizations
Research & Development (289)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 47 | 43 | 5 | 2004 |
| Teva | For profit | 35 | 32 | 4 | 2003 |
| AstraZeneca | For profit | 31 | 26 | 5 | 2003 |
| Boehringer Ingelheim | For profit | 19 | 19 | 4 | 1998 |
| Merck | For profit | 16 | 15 | 4 | 2004 |
| Sunovion | For profit | 16 | 13 | 3 | 2000 |
| Novartis | For profit | 10 | 9 | 3 | 2007 |
| Amphastar Pharmaceuticals | For profit | 9 | 9 | 3 | 2007 |
| Parexel | For profit | 9 | 0 | 4 | 2010 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 8 | 3 | 4 | 1993 |
| University of British Columbia | Academic/Hospital | 6 | 6 | 2 | 2013 |
| University of California, San Francisco | Academic/Hospital | 6 | 3 | 3 | 1993 |
| Avillion | For profit | 5 | 5 | 2 | 2018 |
| University of Copenhagen | Academic/Hospital | 5 | 5 | 1 | 2011 |
| ALK-Abello, S.A. | For profit | 4 | 4 | 2 | 2006 |
| Chiesi | For profit | 4 | 4 | 1 | 2002 |
| Harvard University | Academic/Hospital | 4 | 1 | 3 | 1993 |
| Hebrew University | Academic/Hospital | 4 | 3 | 1 | 1999 |
| Intech Biopharm Ltd. | For profit | 4 | 4 | 2 | 2013 |
| Mylan | For profit | 4 | 3 | 2 | 2005 |
Marketing (82)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| 3M | For profit | NDA2 | Aug 15, 1996 |
| Actavis | For profit | MKTG | Sep 26, 1995 |
| Aizant | For profit | MKTG | Mar 15, 2019 |
| Akorn, Inc. | For profit | MKTG | Jan 15, 1998 |
| Am Therap | For profit | MKTG | — |
| Amneal Pharmaceuticals | For profit | MKTG | May 12, 2010 |
| Amneal Pharmaceuticals | For profit | SYN | May 21, 2018 |
| Apotex | For profit | MKTG | Apr 1, 2003 |
| Appco Pharma | For profit | MKTG | Jun 29, 2018 |
| Appco Pharma | For profit | SYN | Jun 29, 2018 |
| Arise Pharmaceuticals | For profit | MKTG | Mar 15, 2019 |
| Armstrong Pharmaceuticals | For profit | MKTG | Aug 14, 1996 |
| AstraZeneca | For profit | NDA2 | Jan 10, 2023 |
| Aurobindo Pharma | For profit | MKTG | Oct 17, 2017 |
| Bausch & Lomb | For profit | MKTG | Jun 18, 1998 |
| Bausch Health Companies | For profit | MKTG | Jun 18, 1998 |
| Boehringer Ingelheim | For profit | MKTG | Oct 24, 1996 |
| Boehringer Ingelheim | For profit | NDA2 | Oct 24, 1996 |
| Chartwell Pharmaceuticals | For profit | SYN | Dec 27, 2006 |
| Chartwell Pharmaceuticals | For profit | MKTG | Jun 26, 2007 |
| Cipla | For profit | MKTG | Dec 31, 2007 |
| Copley Pharmaceuticals | For profit | MKTG | — |
| Cosette | For profit | MKTG | Sep 25, 1995 |
| Cosette | For profit | SYN | Sep 25, 1995 |
| DAVA Pharmaceuticals | For profit | MKTG | Dec 20, 1989 |
| Dash Pharms | For profit | MKTG | Jan 17, 1991 |
| Epic Pharma Llc | For profit | MKTG | Feb 9, 1999 |
| Eywa Pharma | For profit | MKTG | Oct 8, 2020 |
| Fosun | For profit | MKTG | Dec 21, 2006 |
| Fosun | For profit | SYN | Mar 23, 1989 |
| G & W Laboratories Inc. | For profit | MKTG | Sep 25, 1995 |
| Genpharm | For profit | MKTG | Aug 19, 1997 |
| GlaxoSmithKline | For profit | NDA2 | May 1, 1981 |
| Hi Tech Pharmaceuticals | For profit | MKTG | Jan 15, 1998 |
| Hikma | For profit | MKTG | Jan 30, 1998 |
| Kindeva | For profit | MKTG | Aug 15, 1996 |
| Kindeva | For profit | NDA2 | Aug 15, 1996 |
| Landela Pharmaceutical | For profit | MKTG | Apr 4, 2006 |
| Lannett Company, Inc. | For profit | MKTG | Dec 27, 2006 |
| Lupin | For profit | MKTG | Aug 24, 2020 |
| Lupin | For profit | SYN | Aug 24, 2020 |
| Medarex | For profit | MKTG | Aug 19, 1997 |
| Mova | For profit | MKTG | Sep 30, 1994 |
| Muro Pharmaceuticals | For profit | NDA2 | Dec 23, 1992 |
| Mylan | For profit | MKTG | Jan 17, 1991 |
| Mylan | For profit | SYN | Feb 21, 1992 |
| Mylan | For profit | NDA2 | Mar 21, 2001 |
| Nephron Pharmaceuticals Corporation | For profit | MKTG | Sep 17, 1997 |
| Novartis | For profit | MKTG | Jun 1, 2021 |
| Padagis Us | For profit | MKTG | Feb 24, 2020 |
| Perrigo | For profit | MKTG | Feb 24, 2020 |
| Pliva | For profit | MKTG | Jan 30, 1989 |
| Quagen Pharma | For profit | MKTG | Sep 6, 2019 |
| Rising Pharmaceuticals | For profit | SYN | Jan 29, 2007 |
| Rising Pharmaceuticals | For profit | MKTG | Jun 29, 2018 |
| Ritedose | For profit | MKTG | Dec 16, 2008 |
| Roxane Laboratories | For profit | MKTG | Feb 13, 2001 |
| SENTISS | For profit | MKTG | Jan 15, 1998 |
| Sandoz | For profit | MKTG | Jun 1, 2021 |
| Sandoz | For profit | SYN | Jun 1, 2021 |
| Schering | For profit | NDA2 | May 1, 1981 |
| Schering-Plough | For profit | NDA | May 1, 1981 |
| Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | For profit | MKTG | Oct 17, 2017 |
| Strides Pharma Science | For profit | MKTG | Dec 20, 1989 |
| Sun Pharmaceuticals | For profit | SYN | Jul 21, 2017 |
| Sun Pharmaceuticals | For profit | MKTG | Jul 21, 2017 |
| Sun Pharmaceuticals | For profit | SYN | Feb 1, 1989 |
| Teva | For profit | SYN | Dec 28, 1995 |
| Teva | For profit | SYN | Oct 29, 2004 |
| Teva | For profit | MKTG | Apr 7, 1989 |
| Teva | For profit | SYN | Nov 9, 1999 |
| Teva | For profit | SYN | Apr 13, 2007 |
| Teva | For profit | NDA2 | Oct 29, 2004 |
| UCB | For profit | MKTG | — |
| Virtus Pharms | For profit | MKTG | Oct 26, 2018 |
| VistaPharm, Inc. | For profit | MKTG | Jun 26, 2007 |
| Warner Chilcott | For profit | MKTG | — |
| Watson Pharmaceuticals | For profit | MKTG | Jan 31, 1991 |
| Watson Pharmaceuticals | For profit | SYN | Nov 24, 2003 |
| Wockhardt | For profit | MKTG | Nov 22, 1999 |
| Yichang Humanwell Pharmaceutical Co.,Ltd | For profit | MKTG | Dec 28, 2021 |
| Zydus Discovery DMCC | For profit | MKTG | Oct 22, 2020 |