Exenatide and Lixisenatide: Medicine Overviews
Exenatide and lixisenatide are older GLP-1 medicines for type 2 diabetes; this overview covers their identity, label indications, EU withdrawals and main safety information.
Content last updated . This page has not been medically reviewed.
Two older GLP-1 medicines
Exenatide and lixisenatide were among the first GLP-1 receptor agonists. They are shorter-acting than newer weekly products such as semaglutide or dulaglutide, and some of their brands have been withdrawn in some markets. Evidence labels used: approved medicine (a regulator approved it for a named use) and, where noted, mixed (a trial did not show the hoped-for result). Regulatory facts below were read from the FDA label on DailyMed and the EMA product pages on 2026-10-22; laws and labels change, and this is not advice about any individual's treatment.Exenatide
Identity. The Byetta label describes exenatide as a synthetic peptide GLP-1 receptor agonist, originally identified in a lizard (Heloderma suspectum). It is a 39-amino acid peptide amide whose sequence only partly overlaps human GLP-1. [1] The medicine itself is made synthetically. Its mean terminal half-life is about 2.4 hours, so it is short-acting. [1]How it works. It enhances glucose-dependent insulin release from pancreatic beta cells, suppresses excess glucagon and slows gastric emptying. [1]
Approved uses.
- US, Byetta (immediate-release). An add-on to diet and exercise to improve blood sugar control in adults with type 2 diabetes. The label says not to combine it with other exenatide products. [1]
- EU, Byetta. Authorized in 2006 for type 2 diabetes alongside other diabetes medicines; the marketing authorization was withdrawn on 01/01/2026. [2]
- EU, Bydureon (an extended-release exenatide). Authorized in 2011; withdrawn 01/01/2026. [3]
- US, Bydureon BCise. Not verified: a DailyMed search for it returned no label on 2026-10-22.
Extended-release products are a different formulation of the same molecule; see depot and extended-release formulations.
Main safety information (Byetta label).
- Contraindications. Prior severe allergic reaction to exenatide, and a history of drug-induced immune-mediated thrombocytopenia (low platelets) from exenatide products; serious bleeding, which may be fatal, has been reported. [1]
- Pancreatitis. Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing cases, has been observed with GLP-1 receptor agonists including Byetta. [1]
- Kidneys. Not recommended in severe kidney impairment or end-stage kidney disease. [1]
- Common effects. Nausea, low blood sugar, vomiting, diarrhea, feeling jittery, dizziness, headache, indigestion, constipation and weakness. Nausea usually decreases over time. [1]
- Children. Safety and effectiveness have not been established. A trial in 120 patients aged 10 to 17 with type 2 diabetes did not demonstrate effectiveness (label: mixed or negative for that use). [1]
Lixisenatide
Identity. The Soliqua label describes lixisenatide as a synthetic analogue of human GLP-1, a protein of 44 amino acids amidated at the C-terminal end. [4]How it works. It increases glucose-dependent insulin release, decreases glucagon secretion and slows gastric emptying. [4]
Where it is sold.
- US. I found no stand-alone lixisenatide label in a DailyMed search on 2026-10-22. The label found was Soliqua 100/33, a fixed combination of insulin glargine and lixisenatide for adults with type 2 diabetes. [4]
- EU. The stand-alone product Lyxumia was authorized in 2013; its marketing authorization was withdrawn on 18/12/2025. [5] Suliqua, the insulin glargine and lixisenatide combination, is listed for adults with type 2 diabetes with no withdrawal date shown. [6]
A fixed combination is a different product from either ingredient alone, and the Soliqua label says it should not be combined with another GLP-1 receptor agonist and has not been studied with mealtime insulin. [4] See insulin and insulin analogues and active ingredient, brand, formulation and indication.
Main safety information (Soliqua label).
- Its warnings list opens with severe, generalized allergic reactions (anaphylaxis), then acute pancreatitis. [4]
- Common effects in 5% or more of people: low blood sugar, nausea, nasopharyngitis (cold-like symptoms), diarrhea, upper respiratory infection and headache. [4]
- Safety and effectiveness have not been established in children. [4]
What this tells us
A withdrawal date is not a safety verdict: the EMA pages read state the dates but give no reasons. [2][5] Compare them with newer drugs in metabolic and diabetes peptide medicines. Anyone currently using these medicines should ask their prescriber before any change.Frequently asked questions
Is exenatide a peptide?
Yes. The US label calls Byetta a synthetic 39-amino acid peptide amide. [1]
Is lixisenatide still sold?
In the EU its stand-alone product Lyxumia was withdrawn on 18/12/2025, and the US label I found covers only the Soliqua combination. [5][4]
Does Byetta carry the thyroid tumor boxed warning that some other GLP-1 drugs have?
The Byetta label text I read contains no boxed warning. Its animal-study section reports benign thyroid C-cell adenomas in female rats at all exenatide doses. The semaglutide label, by contrast, opens with a boxed thyroid warning. [1][7] Other exenatide products were not checked.
Were these medicines withdrawn because they were unsafe?
The EMA pages read give withdrawal dates but not reasons, so that cannot be concluded. [2]
References
- Byetta (exenatide) prescribing information, AstraZeneca, DailyMed listing dated 2025-09-08. Source. Read 2026-10-22.
- Byetta EPAR product page, European Medicines Agency. Source. Read 2026-10-22.
- Bydureon EPAR product page, European Medicines Agency. Source. Read 2026-10-22.
- Soliqua 100/33 (insulin glargine and lixisenatide) prescribing information, Sanofi, DailyMed listing dated 2026-03-20. Source. Read 2026-10-22.
- Lyxumia EPAR product page, European Medicines Agency. Source. Read 2026-10-22.
- Suliqua EPAR product page, European Medicines Agency. Source. Read 2026-10-22.
- Ozempic (semaglutide) injection prescribing information, Novo Nordisk, DailyMed listing dated 2026-06-10. Source. Read 2026-10-22.