Drugs / albiglutide
albiglutide
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Eperzan | — | 2018-10-29 | europa.eu ↗ |
| Approved | US (FDA) | TANZEUM | — | 2014-04-15 | fda.gov ↗ |
| Approved | EU (EMA) | Eperzan | — | 2014-03-20 | europa.eu ↗ |
Trials 26 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT01147718 | Jun → Nov 2010 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01147731 | Jun → Sep 2010 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01147692 | May → Aug 2010 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01077505 | Mar → Nov 2010 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00938158 | Aug 2009 → Apr 2011 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00530309 | Aug 2007 → Apr 2008 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00394030 | Oct 2006 → Mar 2007 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT02284009 | Oct 2014 → Oct 2017 | type 1 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01357850 | Sep 2010 → Sep 2012 | congestive heart failure | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00518115 | Apr 2007 → May 2008 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 311 trials | ||||||
| Phase 3 | NCT03015519 | Aug 2017 → Apr 2020 | type 2 diabetes mellitus | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 3 | NCT02683746 | Mar 2016 → Apr 2017 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02229240 | Aug → Dec 2015 | type 2 diabetes mellitus | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 3 | NCT02229227 | Nov 2014 → Jul 2017 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01733758 | Feb 2013 → Jun 2014 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01128894 | May 2010 → Sep 2011 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00838916 | Feb 2009 → Jan 2012 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00838903 | Feb 2009 → Jan 2012 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00839527 | Feb 2009 → Jan 2012 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00849056 | Jan 2009 → Nov 2011 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00849017 | Jan 2009 → Nov 2011 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT02750930 | Oct 2016 → Mar 2017 | type 2 diabetes mellitus | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 4 | NCT02793154 | Sep 2016 → Mar 2017 | type 2 diabetes mellitus | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 4 | NCT02802514 | Sep 2016 → Aug 2017 | diabetes mellitus | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 4 | NCT02465515 | Jul 2015 → Feb 2018 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT02496221 | Jun → Oct 2015 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
Also used as a comparator or background therapy in 11 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01406262 Comparator | Jul → Dec 2011 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00537719 Comparator | Dec 2007 → Apr 2008 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT01475734 Comparator | Dec 2011 → Jul 2012 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01357889 Comparator | Jul 2011 → Oct 2012 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01098461 Comparator | Apr 2010 → May 2011 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00354536 Comparator | Feb → Sep 2006 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT02787551 Comparator | Jul 2016 → May 2018 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01777282 Comparator | Feb 2013 → Jan 2015 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01098539 Comparator | May 2010 → Nov 2012 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00976391 Comparator | Sep 2009 → Oct 2011 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02846233 Comparator | Aug 2016 → Dec 2018 | type 2 diabetes mellitus | University of California, San Francisco | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 40 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | albiglutide | “Albiglutide is a glucagon-like peptide-1 analogue composed of tandem copies of modified human glucagon-like peptide-1 (7-36) coupled to recombinant human albumin that is...” PMID 25387217 ↗ Nov 201434“BACKGROUND: Albiglutide (GSK716155) is a GLP-1 agonist indicated for type 2 diabetes.” PMID 27039125 ↗ Mar 2016 “Albiglutide (Tanzeum) or , Dulaglutide (Trulicity)” NCT02846233 ↗ “albiglutide subcutaneous injection” NCT00354536 ↗ |
| Known as | Albiglutida | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107841 ↗ |
| Known as | Albiglutide (genetical recombination) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107841 ↗ |
| Known as | Eperzan | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107841 ↗ |
| Known as | GSK716155 | “BACKGROUND: Albiglutide (GSK716155) is a GLP-1 agonist indicated for type 2 diabetes.” PMID 27039125 ↗ Mar 20166“subcutaneously injected GSK716155 (albiglutide)” NCT01098461 ↗ “Albiglutide (GSK716155) or exenatide” NCT00518115 ↗ “Biological: albiglutide (GSK716155)” NCT01357889 ↗ |
| Known as | Tanzeum | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107841 ↗ |
| Action | Activate | “Clinical pharmacology of albiglutide, a GLP-1 receptor agonist.” PMID 25387217 ↗ Nov 2014 |
| Modality | Peptide | “Albiglutide is a glucagon-like peptide-1 analogue composed of tandem copies of modified human glucagon-like peptide-1 (7-36) coupled to recombinant human albumin” PMID 25387217 ↗ Nov 2014 |
| Route | Subcutaneous | “albiglutide subcutaneous injection” NCT00354536 ↗ |
| Target | GLP1R | “the glucagon-like peptide-1 (GLP-1) receptor agonist albiglutide” PMID 25263215 ↗ Oct 2014 |