Drugs / GW642444M

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Revinty Ellipta 2014-05-02 europa.eu
Approved US (FDA) BREO ELLIPTA 2013-05-10 fda.gov

Trials 7 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT01266980 Nov 2010 → Mar 2011 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT01266941 Oct 2010 → Jul 2011 asthma GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT00866515 Dec 2008 → Mar 2009 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT00538057 Oct → Dec 2007 asthma GlaxoSmithKline Completed No outcome recorded
Phase 22 trials
Phase 2 NCT00600171 Dec 2007 → Sep 2008 asthma GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT00381667 Aug 2006 → Jan 2007 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 31 trial
Phase 3 NCT03184987 Jun 2017 → Jun 2019 asthma GlaxoSmithKline Completed No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT03378648 Comparator Dec 2017 → Apr 2019 asthma, chronic obstructive pulmonary disease Chiesi Farmaceutici S.p.A. Completed No outcome recorded
Phase 21 trial
Phase 2 NCT01128595 Comparator May 2010 → May 2011 asthma GlaxoSmithKline Completed No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 10 sources stand behind the page.

FieldValueCited text
Known as GW642444M ClinicalTrials.gov intervention name — accepted as the source's own label NCT00381667
6

NCT00866515

NCT01266941

NCT00538057

NCT01266980

NCT01128595

NCT00600171

Known as Vilanterol (as trifenatate) ChEMBL registry synonym — accepted as the source's own label CHEMBL1198857
Known as vilanterol trifenatate “Fixed Dose Combination Therapy Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate in Japanese Patients With Asthma” NCT03184987
1

NCT03378648

Known as Vilanterol trifenatate component of anoro ellipta ChEMBL registry synonym — accepted as the source's own label CHEMBL1198857
Known as Vilanterol trifenatate component of breo ellipta ChEMBL registry synonym — accepted as the source's own label CHEMBL1198857
Known as Vilanterol trifenatate component of trelegy ellipta ChEMBL registry synonym — accepted as the source's own label CHEMBL1198857
Action Activate “a long-acting beta 2 specific agonist” NCT00381667
1

“Beta-2 adrenergic receptor agonist” CHEMBL1198857

Modality Small molecule CHEMBL1198857
Route Inhaled “GW642444M via the inhaled route” NCT00381667
Target ADRB2 “Beta-2 adrenergic receptor agonist” CHEMBL1198857