salmeterol
Trade name: serevent
Approved
Feb 4, 1994
Salmeterol is a long-acting beta2-adrenergic agonist. Although beta2-adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-adrenoceptors are the predominant receptors in the heart, there are also beta2-adrenoceptors in the human heart comprising 10% to 50% of the total beta-adrenoceptors. The precise function of these is not yet established, but they raise the possibility that even highly selective beta2-agonists may have cardiac effects. It is FDA approved for the treatment of asthma, prevention of exercise-induced bronchospasm, maintenance treatment of chronic obstructive pulmonary disease. Common adverse reactions include musculoskeletal pain, headache, influenza, nasal/sinus congestion, pharyngitis, rhinitis, tracheitis/bronchitis, cough, throat irritation, viral respiratory infection. Salmeterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of salmeterol on the vascular system may be potentiated by these agents. Coadministration of salmeterol and ketoconazole was associated with more frequent increases in QTc duration compared with salmeterol and placebo administration. — NCATS
Clinical trial activity
334 trials · 156 clinical orgs · 5 marketing orgs
Earliest trial started Feb 1, 1999 (NCT02172287)
Timeline
1990s
- Feb 4, 1994
Glaxo — Earliest FDA Approval
- Feb 4, 1994
GlaxoSmithKline — NDA Secondary Org
- Feb 4, 1994
Glaxo — NDA Organization
- Jan 1, 1999
Earliest Phase 3 Sponsor(trial)
2000s
- Aug 24, 2000
GlaxoSmithKline — Marketing Organization
- Jan 1, 2003
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2004
Earliest Phase 1 Sponsor(trial)
2010s
2020s
- Dec 17, 2020
Hikma — Marketing Organization
Indications
Approved for
Studied for
- Abdominal Injuries · Phase 3
- Adipose Tissue · Phase 2
- Asthma, Exercise-Induced · Phase 3
- Body Contouring · Phase 2
- Body Fat Distribution · Phase 2
- Body Weight · Phase 2
- Bronchial Spasm · Phase 4
- Bronchiolitis Obliterans · Phase 3
- Bronchitis, Chronic · Phase 4
- Candidiasis, Oral · Phase 4
- Depression · Phase 4
- Edema · Phase 1/Phase 2
- Emphysema · Phase 4
- Exercise · Phase 4
- Healthy Volunteers · Phase 4
- Hematopoietic Stem Cell Transplantation · Phase 3
- Lung Diseases · Phase 3
- Lung Diseases, Obstructive · Phase 2
- Quality of Life · Phase 4
- Rhinitis, Allergic · Phase 4
- Spinal Cord Injuries · Phase 1
- Therapeutic Equivalency · Phase 1
- Thyroid Gland · Phase 2
- Voice Disorders · Phase 4
Mechanism of action
- Beta-2 adrenergic receptorAGONIST
ADRB2 agonist
Combination products
advair diskus
with fluticasone
Also known as advair hfa, airduo digihaler, airduo respiclick, fluticasone propionate/salmeterol (fs), wixela inhub
Approval history
- approvedPriority reviewFeb 4, 1994
Chemistry & pharmacology
SMILES
OCc1cc(C(O)CNCCCCCCOCCCCc2ccccc2)ccc1O- Mol. weight
- 415.57 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Topical
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
Yes
Sources
- ChEMBLCHEMBL1263 ↗
- WikipediaSalmeterol ↗
- NCATS2I4BC502BT ↗
- ChEMBLCHEMBL1082607 ↗
Also known as
- beglan
- beglan
- budesonide / salmeterol
- cryogenine
- cryogenine, (10alpha)-isomer
- gr-33343 g
- gr-33343 g
- gr-33343-g
- gr-33343-g
- gr-33343x
- gr-33343x
- gr-33343-x
- gr-33343-x
- gw815sf
- lipo-202
- neovent
- salmaterol
- salmaterol
- salmaterol
- salmeterol
- salmeterol
- salmeterol
- salmeterol
- salmeterol
- salmeterol
- salmeterol
- salmeterol
- salmeterol / fluticasone propionate
- salmeterolum
- salmeterolum
- salmeterol xinafoate
- salmeterol xinafoate
- salmeterol xinafoate
- salmeterol xinafoate
- salmeterol xinafoate
- salmeterol xinafoate / fluticasone propionate
- serevent
- serevent
- serevent
- serevent
- serevent
- serevent
- serevent
- serevent
- soltel
- vertine
- vertine
- vertine
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06983665 | N/A | May 25, 2025 | Government of China, Jinan University |
| NCT05776927 | Phase 3 | Dec 23, 2024 | Novartis |
| NCT06676319 | Phase 2 | Nov 11, 2024 | Sanofi |
| NCT06657547 | N/A | Nov 1, 2024 | University of Copenhagen |
| NCT06655012 | N/A | Nov 1, 2024 | University of Copenhagen |
| NCT06654986 | N/A | Nov 1, 2024 | University of Copenhagen |
| NCT06040268 | Phase 1/Phase 2 (Phase 2) | Dec 12, 2023 | Department of Defense, University of Colorado, Denver |
| NCT06025214 | Phase 1 | Aug 22, 2023 | BECRO Ltd., Respirent Pharmaceuticals Co Ltd. |
| NCT05982990 | Phase 1 | Aug 1, 2023 | BECRO Ltd., Respirent Pharmaceuticals Co Ltd. |
| NCT05697003 | Phase 1 | Feb 17, 2023 | BECRO Ltd., Respirent Pharmaceuticals Co Ltd. |
| NCT05664061 | Phase 3 | Dec 20, 2022 | BECRO Ltd., Respirent Pharmaceuticals Co Ltd., University of Ioannina |
| NCT04997304 | Phase 4 | Jul 9, 2021 | Teva, University of Michigan |
| NCT04655508 | Phase 3 | Mar 31, 2021 | Assistance Publique - Hôpitaux de Paris, GlaxoSmithKline |
| NCT04677959 | Phase 4 | Feb 16, 2021 | Teva |
| NCT04503460 | Phase 4 | Oct 31, 2020 | European Research Council, Imperial College London |
| NCT04564456 | Phase 1 | Sep 22, 2020 | BECRO Ltd., Respirent Pharmaceuticals Co Ltd., University of Thessaly |
| NCT04546256 | Phase 1 | Sep 1, 2020 | BECRO Ltd., Respirent Pharmaceuticals Co Ltd., University of Thessaly |
| NCT04462822 | Phase 1 | Aug 24, 2020 | BECRO Ltd., Respirent Pharmaceuticals Co Ltd., University of Thessaly |
| NCT04124094 | Phase 1 | Oct 1, 2019 | BECRO Ltd., Respirent Pharmaceuticals Co Ltd., University of Thessaly |
| NCT03975166 | Phase 1 | May 21, 2019 | BECRO Ltd., Respirent Pharmaceuticals Co Ltd., University of Thessaly |
Organizations
Research & Development (156)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 112 | 90 | 5 | 1999 |
| Novartis | For profit | 29 | 29 | 4 | 2006 |
| Boehringer Ingelheim | For profit | 28 | 28 | 4 | 1999 |
| Teva | For profit | 16 | 13 | 4 | 2005 |
| Neothetics, Inc | For profit | 13 | 13 | 3 | 2009 |
| Respirent Pharmaceuticals Co Ltd. | For profit | 13 | 13 | 2 | 2018 |
| BECRO Ltd. | For profit | 12 | 0 | 2 | 2018 |
| AstraZeneca | For profit | 10 | 8 | 4 | 2003 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 8 | 1 | 2 | 2004 |
| University of Colorado, Denver | Academic/Hospital | 8 | 3 | 4 | 2003 |
| University of Thessaly | Academic/Hospital | 8 | 0 | 1 | 2018 |
| Chiesi | For profit | 6 | 5 | 3 | 2004 |
| Merck | For profit | 6 | 4 | 3 | 2005 |
| Orion Corporation | For profit | 6 | 6 | 1 | 2012 |
| Pennsylvania State University | Academic/Hospital | 6 | 5 | 2 | 2004 |
| University of Wisconsin | Academic/Hospital | 6 | 1 | 3 | 2003 |
| Harvard University | Academic/Hospital | 5 | 3 | 2 | 2004 |
| Pfizer | For profit | 5 | 2 | 3 | 2007 |
| Sanofi | For profit | 5 | 5 | 1 | 2011 |
| Sunovion | For profit | 5 | 3 | 3 | 2002 |
Marketing (10)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Glaxo | For profit | NDA | Feb 4, 1994 |
| GlaxoSmithKline | For profit | NDA2 | Feb 4, 1994 |
| GlaxoSmithKline | For profit | MKTG | Aug 24, 2000 |
| Hikma | For profit | MKTG | Dec 17, 2020 |
| Hikma | For profit | SYN | Dec 17, 2020 |
| Mylan | For profit | MKTG | Jan 30, 2019 |
| Mylan | For profit | SYN | Jan 30, 2019 |
| Teva | For profit | MKTG | Jan 27, 2017 |
| Teva | For profit | SYN | Dec 13, 2021 |
| Teva | For profit | NDA2 | Jan 27, 2017 |