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vilanterol

Trade name: Anoro Elipta

Small moleculeapproved

Approved

May 10, 2013

Vilanterol (INN, USAN) is an ultra-long-acting β2 adrenoreceptor agonist (ultra-LABA), which was approved in May 2013 in combination with fluticasone furoate for sale as Breo Ellipta by GlaxoSmithKline for the treatment of chronic obstructive pulmonary disease (COPD). Its pharmacological effect is attributable to stimulation of intracellular adenylyl cyclase which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3’,5’-adenosine monophosphate (cAMP). Increases in cyclic AMP are associated with relaxation of bronchial smooth muscle and inhibition of release of hypersensitivity mediators from mast cells in the lungs. Vilanterol is available in following combinations: a) with inhaled corticosteroid fluticasone furoate — fluticasone furoate/vilanterol (trade names Breo Ellipta , Relvar Ellipta; b) with muscarinic antagonist umeclidinium bromide — umeclidinium bromide/vilanterol (trade name Anoro Ellipta). — NCATS

Clinical trial activity

144 trials · 32 clinical orgs · 1 marketing orgs

Phase 1
29
Phase 2
93
Phase 3
69
Phase 4
20

Earliest trial started Jan 1, 2005 (NCT00354874)

Timeline

2000s

  1. Jan 1, 2005

    GlaxoSmithKline — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2007

    GlaxoSmithKline — Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2009

    GlaxoSmithKline — Earliest Phase 3 Sponsor(trial)

2010s

  1. May 10, 2013

    Earliest FDA Approval

  2. May 10, 2013

    GlaxoSmithKline — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedMay 10, 2013

Chemistry & pharmacology

Loading structure…

SMILES

OCc1cc([C@@H](O)CNCCCCCCOCCOCc2c(Cl)cccc2Cl)ccc1O
Mol. weight
486.44 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 4-{(1r)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol
  • 4-{(1r)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol
  • 4-(2-((6-((2-(((2,6-dichlorophenyl)methyl)oxy)ethyl)oxy)hexyl)amino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol
  • breo ellipta
  • breo ellipta
  • fluticasone furoate / umeclidinium bromide / vilanterol trifenatate
  • fluticasone furoate, umeclidinium bromide, vilanterol trifenatate
  • fluticasone furoate / vilanterol
  • fluticasone furoate / vilanterol
  • fluticasone furoate / vilanterol trifenatate
  • gw6422444
  • gw642444
  • gw642444
  • gw642444m
  • gw642444m
  • gw642444m
  • gw642444m
  • gw642444x
  • gw642444x
  • gw642444x
  • gw642444x
  • gw642444x
  • umeclidinium bromide / vilanterol
  • umeclidinium bromide / vilanterol trifenatate
  • vilanterol
  • vilanterol
  • vilanterol
  • vilanterol
  • vilanterol
  • vilanterol
  • vilanterol
  • vilanterol
  • vilanterol
  • vilantérol
  • vilantérol
  • vilanterol trifenatate
  • vilanterol trifenatate
  • vilanterol trifenatate
  • vilanterol trifenatate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06474039Phase 3Jun 30, 2024Mahidol University
NCT06077019N/AOct 5, 2023University of Copenhagen
NCT06066606N/AOct 5, 2023University of Copenhagen
NCT05292053Phase 4Apr 1, 2022Baylor Scott and White, Baylor University
NCT04923347Phase 4Jan 25, 2022GlaxoSmithKline
NCT04671355Phase 4Oct 4, 2021Chiesi, University of Central Lancashire, University of Dundee
NCT04937387Phase 3Jul 29, 2021GlaxoSmithKline
NCT04651777Phase 3Feb 28, 2021GlaxoSmithKline, University of Western Ontario
NCT04606394Phase 4Dec 2, 2020GlaxoSmithKline, Pulmonary Research Institute of Southeast Michigan
NCT04522596Phase 4Oct 31, 2020Hospital General Universitario Gregorio Marañon
NCT04536675Phase 3Sep 30, 2020Sungkyunkwan University
NCT04265105Phase 2/Phase 3 (Phase 3)Jun 1, 2020Government of Netherlands, Royal College of Surgeons, Ireland
NCT03949842Phase 4Jun 28, 2019GlaxoSmithKline
NCT03739294Phase 2Feb 8, 2019University of Copenhagen
NCT03376932Phase 3Jan 17, 2019GlaxoSmithKline
NCT04750603Phase 4Dec 1, 2018Technion University
NCT03662711Phase 4Sep 30, 2018University of Ferrara
NCT03611699Phase 4Sep 15, 2018University of Iowa
NCT03645434Phase 2Sep 14, 2018AstraZeneca, Parexel
NCT03467425Phase 4Apr 11, 2018GlaxoSmithKline
Showing 20 of 144 trials
Page 1 / 8

Organizations

Research & Development (32)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit12312042005
ParexelFor profit5042012
University of CopenhagenAcademic/Hospital3322019
ChiesiFor profit2222017
NovartisFor profit2212015
University of DundeeAcademic/Hospital2112017
AstraZenecaFor profit1112018
Baylor Scott and WhiteAcademic/Hospital1012022
Baylor UniversityAcademic/Hospital1112022
BI Medical.IncFor profit1012017
Boehringer IngelheimFor profit1012017
Government of MexicoGovernment1112017
Government of NetherlandsGovernment1012020
Hammersmith Medicines ResearchFor profit1012016
Hospital General Universitario Gregorio MarañonAcademic/Hospital1112020
Mahidol UniversityAcademic/Hospital1112024
MundipharmaFor profit1112016
Pulmonary Research Institute of Southeast MichiganAcademic/Hospital1112020
Q2 solutionsFor profit1012017
Queen's University, BelfastAcademic/Hospital1112012
32 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
GlaxoSmithKlineFor profitNDA—
GlaxoSmithKlineFor profitNDA2May 10, 2013
GlaxoSmithKlineFor profitSYNDec 18, 2013