salmeterol

Trade name: serevent

Small moleculeapproved

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

Phase 1
41
Phase 2
159
Phase 3
110
Phase 4
105

Earliest trial started Feb 1, 1999 (NCT02172287)

Timeline

1990s

  1. Feb 4, 1994

    Glaxo — Earliest FDA Approval

  2. Feb 4, 1994

    GlaxoSmithKline — NDA Secondary Org

  3. Feb 4, 1994

    Glaxo — NDA Organization

  4. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Aug 24, 2000

    GlaxoSmithKline — Marketing Organization

  2. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 27, 2017

    Teva — Marketing Organization

  2. Jan 27, 2017

    Teva — NDA Secondary Org

  3. Jan 30, 2019

    Mylan — Marketing Organization

2020s

  1. Dec 17, 2020

    Hikma — Marketing Organization

Indications

Mechanism of action

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

Loading structure…

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

Black box warning

Sources

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 IDPhaseStart dateSponsor(s)
NCT06983665N/AMay 25, 2025Government of China, Jinan University
NCT05776927Phase 3Dec 23, 2024Novartis
NCT06676319Phase 2Nov 11, 2024Sanofi
NCT06657547N/ANov 1, 2024University of Copenhagen
NCT06655012N/ANov 1, 2024University of Copenhagen
NCT06654986N/ANov 1, 2024University of Copenhagen
NCT06040268Phase 1/Phase 2 (Phase 2)Dec 12, 2023Department of Defense, University of Colorado, Denver
NCT06025214Phase 1Aug 22, 2023BECRO Ltd., Respirent Pharmaceuticals Co Ltd.
NCT05982990Phase 1Aug 1, 2023BECRO Ltd., Respirent Pharmaceuticals Co Ltd.
NCT05697003Phase 1Feb 17, 2023BECRO Ltd., Respirent Pharmaceuticals Co Ltd.
NCT05664061Phase 3Dec 20, 2022BECRO Ltd., Respirent Pharmaceuticals Co Ltd., University of Ioannina
NCT04997304Phase 4Jul 9, 2021Teva, University of Michigan
NCT04655508Phase 3Mar 31, 2021Assistance Publique - Hôpitaux de Paris, GlaxoSmithKline
NCT04677959Phase 4Feb 16, 2021Teva
NCT04503460Phase 4Oct 31, 2020European Research Council, Imperial College London
NCT04564456Phase 1Sep 22, 2020BECRO Ltd., Respirent Pharmaceuticals Co Ltd., University of Thessaly
NCT04546256Phase 1Sep 1, 2020BECRO Ltd., Respirent Pharmaceuticals Co Ltd., University of Thessaly
NCT04462822Phase 1Aug 24, 2020BECRO Ltd., Respirent Pharmaceuticals Co Ltd., University of Thessaly
NCT04124094Phase 1Oct 1, 2019BECRO Ltd., Respirent Pharmaceuticals Co Ltd., University of Thessaly
NCT03975166Phase 1May 21, 2019BECRO Ltd., Respirent Pharmaceuticals Co Ltd., University of Thessaly
Showing 20 of 334 trials
Page 1 / 17

Organizations

Research & Development (156)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit1129051999
NovartisFor profit292942006
Boehringer IngelheimFor profit282841999
TevaFor profit161342005
Neothetics, IncFor profit131332009
Respirent Pharmaceuticals Co Ltd.For profit131322018
BECRO Ltd.For profit12022018
AstraZenecaFor profit10842003
National Heart, Lung, and Blood Institute (NHLBI)Government8122004
University of Colorado, DenverAcademic/Hospital8342003
University of ThessalyAcademic/Hospital8012018
ChiesiFor profit6532004
MerckFor profit6432005
Orion CorporationFor profit6612012
Pennsylvania State UniversityAcademic/Hospital6522004
University of WisconsinAcademic/Hospital6132003
Harvard UniversityAcademic/Hospital5322004
PfizerFor profit5232007
SanofiFor profit5512011
SunovionFor profit5332002
156 organizations
Page 1 / 8

Marketing (10)

OrganizationOrg typeRelationshipDate
GlaxoFor profitNDAFeb 4, 1994
GlaxoSmithKlineFor profitNDA2Feb 4, 1994
GlaxoSmithKlineFor profitMKTGAug 24, 2000
HikmaFor profitMKTGDec 17, 2020
HikmaFor profitSYNDec 17, 2020
MylanFor profitMKTGJan 30, 2019
MylanFor profitSYNJan 30, 2019
TevaFor profitMKTGJan 27, 2017
TevaFor profitSYNDec 13, 2021
TevaFor profitNDA2Jan 27, 2017