Short-acting glucagon-like peptide-1 (GLP-1) receptor agonist (exendin-4 based incretin mimetic)
Lixisenatide
Approvedaka AVE0010, Adlyxin, Lyxumia
Lixisenatide is a prescription GLP-1 receptor agonist used to improve blood-glucose control in adults with type 2 diabetes, given as a once-daily subcutaneous injection before a meal. Its cardiovascular safety was tested in the ELIXA outcomes trial, which found neither an increase nor a reduction in major cardiovascular events versus placebo in patients with recent acute coronary syndrome. Regulators approved the drug on the strength of the GetGoal program and ELIXA, but Sanofi has since discontinued the standalone product across the major markets for commercial rather than safety reasons. Where still supplied, it is used under medical supervision.
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Mechanism
In plain terms, lixisenatide copies a natural gut hormone that tells the body to release insulin after eating and to slow how fast the stomach empties, which blunts blood-sugar spikes and reduces appetite. Technically, it is an exendin-4 based peptide that binds and activates the GLP-1 receptor, driving glucose-dependent insulin secretion, suppressing glucagon, and delaying gastric emptying. Its short duration of action gives it a pronounced effect on post-meal glucose.
Regulatory Status by Region
- United States (FDA)Approved as Adlyxin (NDA 208471) in July 2016 for adults with type 2 diabetes. Sanofi discontinued US sales and the standalone product was withdrawn from the US market in early 2023 for commercial reasons, not safety. The fixed-ratio insulin glargine combination Soliqua remains marketed.
- Australia (TGA)Registered on the ARTG as Lyxumia in 2013 as a prescription-only medicine. Sanofi cancelled the standalone Lyxumia ARTG entry in February 2021.
- European Union (EMA)Authorised as Lyxumia on 1 February 2013 for type 2 diabetes. The marketing authorisation was withdrawn on 18 December 2025 at Sanofi's request for commercial reasons. The insulin glargine combination Suliqua remains authorised.
- WADANot listed as a prohibited substance on the WADA Prohibited List (2026). GLP-1 receptor agonists are not classified as prohibited in or out of competition.
Key Studies
- ELIXA (Pfeffer et al.): cardiovascular safety of lixisenatide after acute coronary syndrome (opens in a new tab) (N Engl J Med 2015;373:2247-2257; DOI 10.1056/NEJMoa1509225; PMID 26630143; NCT01147250)
- ELIXA trial registry record (opens in a new tab) (ClinicalTrials.gov NCT01147250; sponsor Sanofi; 6,068 participants; completed February 2015)
- EMA Lyxumia (lixisenatide) EPAR (opens in a new tab) (European Medicines Agency EPAR; authorised 1 February 2013; marketing authorisation withdrawn 18 December 2025)
Related Clinical Trials
- Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 DiabetesPhase 4 · Not Yet Recruiting
- Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral AgentsPhase 4 · Not Yet Recruiting
- Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)N/A · Active Not Recruiting
- Evaluation of the Efficacy and Safety of GLP-1 Receptor Agonist Therapy In Steroid-Induced DiabetesPhase 4 · Enrolling By Invitation
- A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes MellitusPhase 4 · Active Not Recruiting
- iGlarLixi CGM Study in Chinese T2D Individuals After OADsPhase 4 · Recruiting
- Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in BangladeshPhase 4 · Not Yet Recruiting
- The Effect of Lixisenatide on the Effect of Pituitary HormonesPhase 4 · Unknown
Latest research
Common Questions
- What is Lixisenatide?
- Lixisenatide is a once-daily injectable GLP-1 receptor agonist developed by Sanofi for type 2 diabetes, sold as Adlyxin in the United States and Lyxumia in Europe and Australia. It was authorized by the EMA in 2013 and the FDA in 2016, but the standalone product was later withdrawn from the Australian (2021), US (2023), and European (2025) markets for commercial reasons, and lixisenatide now reaches patients mainly through the fixed-ratio insulin glargine combination (Soliqua/Suliqua).
- Is Lixisenatide approved for medical use?
- Lixisenatide is approved for one or more medical uses in at least one major jurisdiction. United States (FDA): Approved as Adlyxin (NDA 208471) in July 2016 for adults with type 2 diabetes. Sanofi discontinued US sales and the standalone product was withdrawn from the US market in early 2023 for commercial reasons, not safety. The fixed-ratio insulin glargine combination Soliqua remains marketed. European Union (EMA): Authorised as Lyxumia on 1 February 2013 for type 2 diabetes. The marketing authorisation was withdrawn on 18 December 2025 at Sanofi's request for commercial reasons. The insulin glargine combination Suliqua remains authorised. Australia (TGA): Registered on the ARTG as Lyxumia in 2013 as a prescription-only medicine. Sanofi cancelled the standalone Lyxumia ARTG entry in February 2021.
- How does Lixisenatide work?
- In plain terms, lixisenatide copies a natural gut hormone that tells the body to release insulin after eating and to slow how fast the stomach empties, which blunts blood-sugar spikes and reduces appetite. Technically, it is an exendin-4 based peptide that binds and activates the GLP-1 receptor, driving glucose-dependent insulin secretion, suppressing glucagon, and delaying gastric emptying.
- Is Lixisenatide legal in Australia?
- Lixisenatide in Australia (TGA): Registered on the ARTG as Lyxumia in 2013 as a prescription-only medicine. Sanofi cancelled the standalone Lyxumia ARTG entry in February 2021.
- Is Lixisenatide banned in sport?
- Lixisenatide under the World Anti-Doping Agency (WADA) code: Not listed as a prohibited substance on the WADA Prohibited List (2026). GLP-1 receptor agonists are not classified as prohibited in or out of competition.