CDEK
← All drugs Report issue

umeclidinium

Trade name: incruse ellipta

Small moleculeapproved

Approved

Dec 18, 2013

Umeclidinium (used as a bromide salt) is a long-acting, antimuscarinic antagonist, often referred to as an anticholinergic, developed for the treatment of chronic obstructive pulmonary disease (COPD) (alone and in combination with Vilanterol - long-acting beta2-adrenergic agonist). Umeclidinium has similar affinity to the subtypes of muscarinic receptors M1 to M5 with Ki values of 0.16 nM, 0.15 nM, 0.06 nM, 0.05 nM and 0.13 nM for M1, M2, M3, M4 and M5, respectively. Umeclidinium is selective against mAChR over other unrelated receptors or channels such as κ and σ opiod receptors, Na+ channel and dopamine transporter. In the airways, it exhibits pharmacological effects through the inhibition of M3 receptor at the smooth muscle leading to bronchodilation. There is potential for an additive interaction with concomitantly used anticholinergic medicines. — NCATS

Clinical trial activity

85 trials · 23 clinical orgs · 1 marketing orgs

Phase 1
18
Phase 2
54
Phase 3
38
Phase 4
14

Earliest trial started May 1, 2007 (NCT00475436)

Timeline

2000s

  1. Jan 1, 2007

    GlaxoSmithKline — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2007

    GlaxoSmithKline — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2011

    GlaxoSmithKline — Earliest Phase 3 Sponsor(trial)

  2. Dec 18, 2013

    Earliest FDA Approval

  3. Dec 18, 2013

    GlaxoSmithKline — Marketing Organization

  4. Apr 30, 2014

    GlaxoSmithKline — First NDA Organization

  5. Apr 30, 2014

    GlaxoSmithKline — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedDec 18, 2013

Chemistry & pharmacology

Loading structure…

SMILES

OC(c1ccccc1)(c1ccccc1)C12CC[N+](CCOCc3ccccc3)(CC1)CC2
Mol. weight
428.6 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 1-[2-(benzyloxy)ethyl]-4-[hydroxy(diphenyl)methyl]-1-azoniabicyclo[2.2.2]octane
  • 1-[2-(benzyloxy)ethyl]-4-[hydroxy(diphenyl)methyl]-1-azoniabicyclo[2.2.2]octane
  • anoro ellipta
  • anoro ellipta
  • fluticasone furoate / umeclidinium bromide / vilanterol trifenatate
  • fluticasone furoate, umeclidinium bromide, vilanterol trifenatate
  • gsk573719
  • gsk573719
  • gsk573719
  • gsk573719
  • gsk 573719
  • gsk 573719
  • gsk573719a
  • gsk573719a
  • gsk573719a
  • incruse
  • incruse
  • incruse
  • incruse
  • incruse
  • umeclidinium
  • umeclidinium
  • umeclidinium
  • umeclidinium
  • umeclidinium
  • umeclidinium
  • umeclidinium
  • umeclidinium
  • umeclidinium
  • umeclidinium brom
  • umeclidinium brom
  • umeclidinium bromide
  • umeclidinium bromide
  • umeclidinium bromide
  • umeclidinium bromide
  • umeclidinium bromide
  • umeclidinium bromide
  • umeclidinium bromide / vilanterol
  • umeclidinium bromide / vilanterol trifenatate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06474039Phase 3Jun 30, 2024Mahidol University
NCT05292053Phase 4Apr 1, 2022Baylor Scott and White, Baylor University
NCT04923347Phase 4Jan 25, 2022GlaxoSmithKline
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
NCT03949842Phase 4Jun 28, 2019GlaxoSmithKline
NCT03376932Phase 3Jan 17, 2019GlaxoSmithKline
NCT03662711Phase 4Sep 30, 2018University of Ferrara
NCT03611699Phase 4Sep 15, 2018University of Iowa
NCT03645434Phase 2Sep 14, 2018AstraZeneca, Parexel
NCT03474081Phase 4Mar 29, 2018GlaxoSmithKline, Parexel
NCT03378648Phase 1/Phase 2 (Phase 2)Dec 28, 2017Chiesi, University of Manchester
NCT05342558Phase 4Sep 19, 2017Government of Mexico
NCT03184987Phase 3Jun 22, 2017BI Medical.Inc, GlaxoSmithKline, Parexel, Q2 solutions, SRL Medisearch, York Bioanalytical Solutions
NCT03034915Phase 4Jun 16, 2017GlaxoSmithKline
NCT03002389Phase 2Jun 5, 2017University of Virginia
NCT03012061Phase 2Jan 25, 2017GlaxoSmithKline
Showing 20 of 85 trials
Page 1 / 5

Organizations

Research & Development (23)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit736942007
ParexelFor profit5042012
NovartisFor profit2212015
AstraZenecaFor profit1112018
Baylor Scott and WhiteAcademic/Hospital1012022
Baylor UniversityAcademic/Hospital1112022
BI Medical.IncFor profit1012017
ChiesiFor profit1112017
Government of MexicoGovernment1112017
Hospital General Universitario Gregorio MarañonAcademic/Hospital1112020
Mahidol UniversityAcademic/Hospital1112024
Pulmonary Research Institute of Southeast MichiganAcademic/Hospital1112020
Q2 solutionsFor profit1012017
Queen's University, BelfastAcademic/Hospital1112012
SRL MedisearchFor profit1012017
Stiefel LaboratoriesFor profit1112016
Sungkyunkwan UniversityAcademic/Hospital1112020
University of FerraraAcademic/Hospital1112018
University of IowaAcademic/Hospital1112018
University of ManchesterAcademic/Hospital1012017
23 organizations
Page 1 / 2

Marketing (2)

OrganizationOrg typeRelationshipDate
GlaxoSmithKlineFor profitMKTGDec 18, 2013
GlaxoSmithKlineFor profitNDAApr 30, 2014