Drugs / GW642444M
GW642444M
also known as
vilanterol trifenatate · Vilanterol (as trifenatate) · Vilanterol trifenatate component of anoro ellipta · Vilanterol trifenatate component of breo ellipta · Vilanterol trifenatate component of trelegy ellipta
Small molecule targets ADRB2 via activation
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 · 1 met primary | ||||||
| Phase 2 | NCT00600171 | Dec 2007 → Sep 2008 | asthma | GlaxoSmithKline | Completed | Met primary |
| 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 |
| Comparator or background therapy2 trials | ||||||
| Phase 1/2 | NCT03378648 Comparator | Dec 2017 → Apr 2019 | asthma, chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT01128595 Comparator | May 2010 → May 2011 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2010-09-21 | GlaxoSmithKline | Results GSK and Theravance announce combination ICS/LABA Phase II results in the Relovair™ development programme gsk.com ↗
The most common adverse events (FFVI; placebo) were nasopharyngitis (18%;15%), headache (15%; 5%), dizziness (5%; 5%) and candidiasis (8%;0%). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2010-09-21 | GlaxoSmithKline | GSK and Theravance announce combination ICS/LABA Phase II results in the Relovair™ development programme gsk.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GW642444M | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01266980 ↗ |
| 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 ↗ |
| 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 ↗ |