Drugs / Lixisenatide
Lixisenatide
also known as
AVE0010 · Lixi · Lyxumia · - lixisenatide (Lyxumia) · AVE 010 · Lixisenatida · Lixisenatide component of soliqua 100/33 · ZP 10
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ADLYXIN | — | 2021-07-30 | fda.gov ↗ |
| Approved | US (FDA) | ADLYXIN | — | 2016-07-27 | fda.gov ↗ |
| Approved | EU (EMA) | Lyxumia | — | 2013-01-31 | europa.eu ↗ |
Trials 49
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials · 1 met primary | ||||||
| Phase 1 | NCT02803918 | May 2017 → Jan 2020 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT02713477 | Apr → Jun 2016 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 1 | NCT02231658 | Jul 2015 → Jul 2018 | diabetes mellitus | Profil Institute for Metabolic Research GmbH | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01572649 | May 2012 → Mar 2014 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01146678 | Jun → Sep 2010 | type 1 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT00931372 | Jun → Aug 2009 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 27 trials · 5 met primary | ||||||
| Phase 2 | NCT03439943 | Jun 2018 → Apr 2021 | Parkinson disease | University Hospital, Toulouse | Completed | Met primary |
| Phase 2 | NCT02274740 | Apr → Aug 2015 | type 2 diabetes mellitus | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT01910194 | Dec 2013 → Oct 2014 | diabetes mellitus | Profil Institute for Metabolic Research GmbH | Completed | No outcome recorded |
| Phase 2 | NCT01596504 | May 2012 → Jul 2013 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 2 | NCT01476475 | Nov 2011 → Dec 2012 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 2 | NCT01175473 | Aug → Nov 2010 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 2 | NCT00299871 | Feb 2006 → Aug 2007 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 325 trials · 20 met primary · 1 missed | ||||||
| Phase 3 | NCT03767543 | Mar 2019 → Oct 2020 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT03434119 | Feb 2018 → Jan 2019 | type 2 diabetes mellitus | Sanofi | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02787551 | Jul 2016 → May 2018 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT02752412 | May 2016 → Oct 2018 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT02168491 | Nov 2014 → Jul 2015 | type 2 diabetes mellitus | Medical University of Vienna | Completed | Met primary |
| Phase 3 | NCT02058160 | Jan 2014 → Jul 2015 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT01960179 | Nov 2013 → Mar 2015 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01940965 | Sep 2013 → Jul 2015 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01798706 | Jun 2013 → Feb 2015 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT01768559 | Jan 2013 → Dec 2014 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT01632163 | Oct 2012 → May 2015 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT01517412 | Feb 2012 → May 2013 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT01169779 | Jul 2010 → Dec 2011 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT01147250 | Jun 2010 → Feb 2015 | acute coronary syndrome | Sanofi | Completed | Met primary |
| Phase 3 | NCT00975286 | Oct 2009 → Aug 2011 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT00976937 | Aug 2009 → Mar 2011 | type 2 diabetes mellitus | Sanofi | Completed | Missed primary |
| Phase 3 | NCT00905255 | May 2009 → Jan 2011 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00866658 | Mar 2009 → Jun 2010 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT00763451 | Sep 2008 → Jan 2011 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT00763815 | Sep 2008 → Jun 2011 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT00713830 | Jul 2008 → Jan 2011 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT00715624 | Jul 2008 → Feb 2011 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT00707031 | Jun 2008 → Nov 2010 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT00712673 | Jun 2008 → Mar 2011 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT00688701 | May 2008 → Dec 2009 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 410 trials · 1 met primary · 2 missed | ||||||
| Phase 4 | NCT07117240 | Jul 2025 → Feb 2028 expected | diabetes mellitus, hyperglycemia | Medical University of Warsaw | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06671587 | Dec 2024 → Sep 2026 overdue | type 2 diabetes mellitus | Sanofi | Recruiting | No outcome recorded |
| Phase 4 | NCT03881995 | Mar 2019 → Jun 2020 | type 2 diabetes mellitus | University Hospital Tuebingen | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03819790 | Oct 2018 → Nov 2019 | type 2 diabetes mellitus | LMC Diabetes & Endocrinology Ltd. | Completed | Missed primary |
| Phase 4 | NCT02941367 | Feb → Aug 2017 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT02767596 | Jul 2016 → Feb 2017 | type 2 diabetes mellitus | Laniado Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02501850 | Oct 2014 → Jul 2015 | type 2 diabetes mellitus | Hospital Universitari Vall d'Hebron Research Institute | Unknown | No outcome recorded |
| Phase 4 | NCT02276196 | Sep 2014 → Apr 2016 | diabetes mellitus, diabetic kidney disease | Amsterdam UMC, location VUmc | Completed | Missed primary |
| Phase 4 | NCT02200991 | Aug 2014 → Nov 2015 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 4 | NCT02020629 | Dec 2013 → Aug 2014 | type 2 diabetes mellitus | Lund University | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02745470 | Feb → Dec 2016 | type 2 diabetes mellitus | Seoul National University Hospital | Completed | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 1/2 | NCT02308254 Comparator | Nov 2013 → Apr 2016 | gastroparesis, type 2 diabetes mellitus | Royal Adelaide Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03798054 Comparator | Feb 2019 → Mar 2021 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02749890 Comparator | May 2016 → May 2018 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT02058147 Comparator | Feb 2014 → Jun 2015 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT07173712 Comparator | Mar 2026 → Jun 2027 expected | type 2 diabetes mellitus | Yanbing Li | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05804513 Comparator | Apr → Oct 2023 | type 1 diabetes mellitus | University of Tartu | Unknown | No outcome recorded |
| Phase 4 | NCT01973231 Comparator | Oct 2013 → Nov 2014 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| — | NCT02640118 Comparator | Aug 2015 → Jul 2016 | post-surgical hypoinsulinemia | University Hospital, Gentofte, Copenhagen | Completed | No outcome recorded |
| — | NCT02244164 Comparator | Oct 2014 → Feb 2023 | type 2 diabetes mellitus | Erasme University Hospital | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2021-06-28 | Sanofi | Results Media Update: New Soliqua®* data shows improved blood sugar control without weight gain versus premixed insulin sanofi.com ↗
The study met both primary endpoints with Soliqua demonstrating noninferiority of blood sugar (HbA 1c ) reduction and superiority on body weight change from baseline compared to premixed insulin. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2021-06-28 | Sanofi | Media Update: New Soliqua®* data shows improved blood sugar control without weight gain versus premixed insulin sanofi.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LIXISENATIDE | “Subjects will receive premixed Insulin glargine + lixisenatide once daily for 12 weeks” NCT03881995 ↗57“Treatment with liraglutide, exenatide or lixisenatide” NCT02501850 ↗ “- lixisenatide (Lyxumia®)” NCT02244164 ↗ “Lyxumia (Lixisenatide)” NCT01910194 ↗ |
| Known as | - lixisenatide (Lyxumia) | “- lixisenatide (Lyxumia®)” NCT02244164 ↗ |
| Known as | AVE 010 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108336 ↗ |
| Known as | AVE0010 | “The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) in comparison to exenatide (Byetta®), as an add-on treatment to metformin, over a...” NCT00707031 ↗32“The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to basal insulin with or without...” NCT00866658 ↗ “The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to metformin, over a period of 24...” NCT00712673 ↗ “The objective of this study is to test whether Lixisenatide (AVE0010) restores first phase and improves second phase insulin response in subjects with diabetes mellitus type 2.” NCT00931372 ↗ “The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo” NCT00713830 ↗ “Insulin glargine/lixisenatide (HOE901/AVE0010)” NCT02058160 ↗ “Insulin glargine/Lixisenatide (HOE901/AVE0010)” NCT02752412 ↗ “Drug: Lixisenatide (AVE0010)” NCT00976937 ↗ “Drug: Lixisenatide (AVE0010)” NCT00975286 ↗ “Drug: LIXISENATIDE AVE0010” NCT02274740 ↗ “Lixisenatide (AVE0010)” NCT01147250 ↗ |
| Known as | Lixi | “a novel titratable fixed-ratio combination of insulin glargine (iGlar) and lixisenatide (Lixi), compared with both components, iGlar and Lixi, given separately in type 2...” PMID 27527848 ↗ Aug 20161“Nine patients with T2DM currently receiving iPremix formulations and poor glycemic control were switched to once-daily injected lixisenatide (Lixi) and basal insulin analogue...” PMID 28357772 ↗ Mar 2017 |
| Known as | Lixisenatida | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108336 ↗ |
| Known as | Lixisenatide component of soliqua 100/33 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108336 ↗ |
| Known as | Lyxumia | “Effects of Victoza® (Liraglutide) Versus Lyxumia® (Lixisenatide) on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion” NCT02231658 ↗1“Lyxumia (Lixisenatide)” NCT01910194 ↗ |
| Known as | ZP 10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108336 ↗ |
| Action | Activate | “lixisenatide, a once-daily prandial glucagon-like peptide-1 receptor agonist” PMID 27267268 ↗ May 20161“Glucagon-like peptide 1 receptor agonist” CHEMBL2108336 ↗ |
| Modality | Peptide | “Lixisenatide is a glucagon-like peptide-1 analog” PMID 23537041 ↗ Mar 2013 |
| Route | Subcutaneous | “treated with subcutaneous lixisenatide doses” PMID 20722676 ↗ Sep 2010 |
| Target | GLP1R | “Glucagon-like peptide 1 receptor agonist” CHEMBL2108336 ↗ |