Lixisenatide
GLP-1 receptor agonist
Also Adlyxin, Lyxumia, Soliqua (component), Soliqua 100/33, AVE0010, ZP10
- Evidence
- AStrong human evidence
- FDA status
- FDA approvedas of 2026-10-26
- Route
- Injection
- Studies cited
- 1 human0 animal or cell
A diabetes drug that lowers blood sugar after meals, now sold only mixed with insulin. A trial of 6,068 people found it neither helped nor harmed the heart.
Sold for
Lixisenatide gets almost no consumer attention; it is a shorter-acting GLP-1 drug that lost out commercially to weekly rivals and now survives mainly as the GLP-1 half of Soliqua.
Studies say
Phase 3 glycemic trials and a 6,068-patient cardiovascular trial support its approval for type 2 diabetes (grade A), with the cardiovascular trial showing neither harm nor benefit.
Why grade A. The glucose-lowering indication rests on the GetGoal phase 3 program summarized in the label, and ELIXA, a randomized placebo-controlled cardiovascular outcomes trial in 6,068 patients after an acute coronary syndrome, established cardiovascular safety. The gap is that lixisenatide showed no cardiovascular benefit and only modest weight loss, so its evidence supports safety and glycemic control, not the outcomes that newer GLP-1 drugs achieved. 12
FDA. Approved. Lixisenatide was approved in 2016 as Adlyxin for type 2 diabetes in adults. Sanofi withdrew standalone Adlyxin from the US market effective January 1, 2023 for commercial reasons; the molecule remains available in Soliqua 100/33, a fixed combination with insulin glargine. 13
Written from 3 cited sources. Fact-checked 2026-10-27: 17 claims checked, 3 corrected. Last refreshed 2026-10-27. Not physician reviewed.
What this means for you
- What people take it for
- Lowering blood sugar in type 2 diabetes.
- Can a US doctor prescribe it?
- Yes, FDA approved for type 2 diabetes; it is now sold only combined with insulin glargine.
- Properly tested in people?
- Yes, in large controlled trials: a trial of 6,068 people.
Evidence checklist
- Randomised controlled trial ELIXA and GetGoal placebo-controlled trialsyes
- Human study over 100 people ELIXA 6,068 patientsyes
- More than one research group Sponsor-run program; no independent group citedno information
- Clinical outcomes, not surrogate markers ELIXA: no cardiovascular benefit or harmyes
- Human safety data beyond case reports Trial and label safety datayes
Drawn from the cited studies below. A dash means the sources give no information.
What it is
Lixisenatide is a 44-amino-acid GLP-1 receptor agonist derived from exendin-4, the lizard-venom peptide that also gave rise to exenatide. Six lysine residues added to the tail slow its breakdown enough for daily injection, though its action is shorter than liraglutide's and much shorter than the weekly agents. Sanofi developed it under license from Zealand Pharma. 1
The FDA approved it in July 2016 as Adlyxin, several years after European approval as Lyxumia. In the US it was later folded into Soliqua 100/33 with insulin glargine. Sanofi announced in October 2022 that standalone Adlyxin would be discontinued in the US from January 2023, citing the availability of alternative treatments and the drug's financial performance, with no safety problem involved. Soliqua is still marketed. 13
How it works
Like other GLP-1 receptor agonists, lixisenatide increases glucose-dependent insulin secretion, suppresses glucagon, and slows gastric emptying. Because it is short-acting and taken before a meal, its largest measurable effect is on the glucose rise after that meal, which is where it differs from the long-acting agents that act more on fasting glucose. That profile is also why it pairs well with a basal insulin, which handles fasting glucose. 1
What human research shows
ELIXA randomized 6,068 adults with type 2 diabetes who had suffered a heart attack or unstable angina within the previous 180 days to lixisenatide or placebo and followed them for a median of 25 months. The primary composite of cardiovascular death, heart attack, stroke, or hospitalization for unstable angina occurred in 13.4 percent on lixisenatide and 13.2 percent on placebo. Lixisenatide met the non-inferiority criterion and did not show superiority. Weight fell by a modest amount more than placebo. 2
The glucose-lowering trials behind the label show reductions in HbA1c and particularly in post-meal glucose compared with placebo, both alone and added to metformin, sulfonylureas, or basal insulin. 1
| Study | Model | Finding |
|---|---|---|
| ELIXA (Pfeffer 2015) | Humans, n=6,068 with type 2 diabetes after acute coronary syndrome, randomized double-blind placebo-controlled, median 25 months | Major cardiovascular events 13.4 versus 13.2 percent; lixisenatide was non-inferior to placebo and not superior. 2 |
| Adlyxin prescribing information (GetGoal program) | FDA label summarizing phase 3 randomized trials | Lowered HbA1c and post-meal glucose versus placebo, with gastrointestinal events the main adverse effect. 1 |
Safety
Nausea, vomiting, and diarrhea were the most common adverse events in the trials and the main reason for stopping. In ELIXA, rates of serious adverse events, severe hypoglycemia, pancreatitis, pancreatic tumors and allergic reactions did not differ from placebo, which addressed the two safety questions the FDA had raised for the class. Allergic reactions including anaphylaxis are a listed warning, and antibodies to the drug develop in a majority of patients and can blunt its effect. 12
Unlike liraglutide and semaglutide, lixisenatide does not carry a boxed thyroid C-cell warning, although its label reports more thyroid C-cell adenomas in two-year studies in mice and rats; whether that matters for people is unknown. Long-term outcome data beyond the two-year ELIXA follow-up are limited. 1
Questions for your clinician
- Would a newer GLP-1 drug with proven heart benefit suit me better?
- Is lixisenatide still available to me, and in what combination?
- What should I do about nausea or a possible allergic reaction?
Questions people ask
Is lixisenatide still available in the US?
Not on its own. Sanofi discontinued Adlyxin effective January 2023 for business reasons. It is still sold combined with insulin glargine as Soliqua 100/33. 13
Does lixisenatide reduce heart attacks?
No. In ELIXA, 6,068 high-risk diabetic patients had the same rate of cardiovascular events on lixisenatide as on placebo. It proved safe for the heart; it did not prove protective. 2
Citations
- FDA 2024: Adlyxin (lixisenatide) prescribing information accessdata.fda.gov
- Pfeffer 2015, NEJM: Lixisenatide in patients with type 2 diabetes and acute coronary syndrome (ELIXA) doi.org
- RxLess 2022: Adlyxin will no longer be available in the US rxless.com