Drugs / albiglutide
albiglutide
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed type 2 diabetes mellitus 2 milestones | |||||
| Filed | EU (EMA) | Eperzan | type 2 diabetes mellitus | 2013-03-07 | “submission of a Marketing Authorisation Application (MAA) for albiglutide, with the proprietary name EPERZAN™, to the European Medicines Agency (EMA)” gsk.com ↗ |
| Filed | US (FDA) | — | type 2 diabetes mellitus | 2013-01-14 | “submission to the US Food and Drug Administration (US FDA) for albiglutide” gsk.com ↗ |
| Withdrawn Indication not stated 3 milestones | |||||
| Withdrawn | EU (EMA) | Eperzan | — | 2018-10-29 | europa.eu ↗ |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
| 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 · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT02284009 | Oct 2014 → Oct 2017 | type 1 diabetes mellitus | GlaxoSmithKline | Completed | Missed primary |
| 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 | Met primary |
| Phase 311 trials · 8 met primary · 1 missed | ||||||
| Phase 3 | NCT03015519 | Aug 2017 → Apr 2020 | type 2 diabetes mellitus | GlaxoSmithKline | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02683746 | Mar 2016 → Apr 2017 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02229240 | Aug → Dec 2015 | type 2 diabetes mellitus | GlaxoSmithKline | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02229227 | Nov 2014 → Jul 2017 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01733758 | Feb 2013 → Jun 2014 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01128894 | May 2010 → Sep 2011 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT00838903 | Feb 2009 → Jan 2012 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00839527 | Feb 2009 → Jan 2012 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00838916 | Feb 2009 → Jan 2012 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00849017 | Jan 2009 → Nov 2011 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00849056 | Jan 2009 → Nov 2011 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | Met primary |
| Phase 45 trials | ||||||
| Phase 4 | NCT02750930 | Oct 2016 → Mar 2017 | type 2 diabetes mellitus | GlaxoSmithKline | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT02793154 | Sep 2016 → Mar 2017 | type 2 diabetes mellitus | GlaxoSmithKline | Terminated | No outcome recorded Stop: Enrollment |
| 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 | Mixed |
| Comparator or background therapy11 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 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 3 | NCT02787551 Comparator | Jul 2016 → May 2018 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| 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 |
| — | NCT02846233 Comparator | Aug 2016 → Dec 2018 | type 2 diabetes mellitus | University of California, San Francisco | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2018-10-02 | GlaxoSmithKline | Results Positive results from Harmony Outcomes study of albiglutide published in The Lancet gsk.com ↗
MACE occurred in 7.1% (N=338) and 9.0% (N=428) of patients receiving albiglutide and placebo in addition to standard of care, respectively. |
| 2014-06-14 | GlaxoSmithKline | Results GSK presents new data for once-weekly Tanzeum/Eperzan (albiglutide) showing blood glucose lowering up to three years in type 2 diabetes gsk.com ↗
Safety data for albiglutide in these studies were also consistent with the results observed up to year one. |
| 2014-04-15 | GlaxoSmithKline | Regulatory GSK receives US approval for once-weekly type 2 diabetes treatment, Tanzeum™ (albiglutide) gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved TanzeumTM (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes. |
| 2014-03-26 | GlaxoSmithKline | Regulatory GSK receives European authorisation for once-weekly type 2 diabetes treatment, Eperzan® (albiglutide) gsk.com ↗
today announced that the European Commission has granted marketing authorisation for its once-weekly diabetes treatment, Eperzan® (albiglutide). |
| 2014-01-24 | GlaxoSmithKline | Regulatory GSK receives positive opinion from the CHMP in Europe for once-weekly EperzanTM (albiglutide) for the treatment of type 2 diabetes gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for albiglutide, under the brand name EperzanTM. |
| 2013-08-02 | GlaxoSmithKline | Regulatory Regulatory update: albiglutide US PDUFA date extended by three months gsk.com ↗
the US Prescription Drug User Fee Act (PDUFA) goal date for albiglutide, an investigational once-weekly treatment for adult patients with type 2 diabetes, has been extended by three months |
| 2013-06-24 | GlaxoSmithKline | Results GSK announces data from five Phase III studies of albiglutide, an investigational once-weekly treatment for type 2 diabetes gsk.com ↗
Albiglutide achieved the primary efficacy endpoint in these five studies, although a hierarchical analysis of noninferiority to pioglitazone was not met in one study, as noted below. |
| 2013-03-07 | GlaxoSmithKline | Regulatory Regulatory update – GSK announces regulatory submission for albiglutide in Europe gsk.com ↗
GlaxoSmithKline plc (GSK) today announced the submission of a Marketing Authorisation Application (MAA) for albiglutide, with the proprietary name EPERZAN™, to the European Medicines Agency (EMA). |
| 2013-01-14 | GlaxoSmithKline | Regulatory Regulatory update – GSK announces submission of albiglutide BLA to the US FDA for the treatment of type 2 diabetes gsk.com ↗
GlaxoSmithKline (GSK) plc today announced a regulatory submission to the US Food and Drug Administration (US FDA) for albiglutide, an investigational once-weekly treatment for adult patients with type 2 diabetes. |
| 2012-07-11 | GlaxoSmithKline | Results GSK announces positive data from Harmony 8 and completion of clinical registration package for albiglutide in type 2 diabetes gsk.com ↗
At the 26-week primary endpoint, albiglutide showed clinically and statistically significant reductions in HbA1c from baseline (8.08% for albiglutide and 8.22% for sitagliptin)and superiority versus sitagliptin (reduction of 0.83% vs 0.52%; p |
| 2012-06-09 | GlaxoSmithKline | Results GSK announces new 52-week data from phase III study of once-weekly albiglutide in type 2 diabetes gsk.com ↗
Detailed findings from a Phase III study comparing the investigational glucagon-like peptide-1 (GLP-1) receptor agonist albiglutide to prandial insulin (Lispro), were presented today at the American Diabetes Association Meeting (ADA) in Philadelphia, USA, and show that the effect is maintained out to 52 weeks. |
| 2012-04-03 | GlaxoSmithKline | Results GSK receives further data from phase lll studies of albiglutide in type 2 diabetes gsk.com ↗
In this study, the first of its kind for the class, albiglutide produced clinically significant reductions in HbA1c from baseline and non-inferiority versus preprandial lispro insulin after 26 weeks of treatment, achieving the primary endpoint. |
| 2011-11-16 | GlaxoSmithKline | Results GSK receives initial data from the first completed phase lll study of albiglutide in type 2 diabetes gsk.com ↗
Results showed a reduction in HbA1c of 0.78% for patients receiving albiglutide compared to a reduction of 0.99% for liraglutide. |
All press releases naming this drug 14 releases
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 |