Lixisenatide is the quiet member of the class. It reached the United States in 2016, a decade after exenatide and six years after liraglutide, and it never had a weight or cardiovascular indication. It matters for two reasons: it is the GLP-1 component of Soliqua 100/33, a fixed combination with insulin glargine, and its cardiovascular trial ELIXA was the first completed outcome trial for any GLP-1 drug.
Mechanism and receptor profile
The Adlyxin label states that lixisenatide is a GLP-1 receptor agonist that increases glucose-dependent insulin release, decreases glucagon secretion, and slows gastric emptying. Like exenatide it is built on exendin-4, not on the human GLP-1 sequence. Its half-life is short enough that once-daily dosing gives a peak around the first meal and low exposure by evening; the label's pharmacodynamics section reports reductions in fasting glucose and in the post-meal glucose curve after a standardised breakfast.
FDA approvals, with dates
| Date | Product | What was approved | Record |
|---|---|---|---|
| 27 Jul 2016 | Adlyxin | Glycemic control in adults with type 2 diabetes; 10 mcg and 20 mcg pens | BLA 208471, original |
| 21 Nov 2016 | Soliqua 100/33 | Fixed-ratio insulin glargine 100 units/mL with lixisenatide 33 mcg/mL | BLA 208673, original |
| 12 Mar 2026 | Adlyxin | Labeling revision (most recent label on file) | BLA 208471, S-012 |
Adlyxin was originally filed as an NDA; Drugs@FDA now lists it under a BLA number because insulin-class and peptide products were transitioned to biologic applications in 2020. Its marketing status in Drugs@FDA on 4 September 2026 is "prescription", not discontinued.
Dosing as the label states it
- Start at 10 mcg subcutaneously once daily for 14 days. The label says the 10 mcg dose is to reduce gastrointestinal reactions and is not effective for glycemic control.
- Increase to the maintenance dose of 20 mcg once daily on day 15.
- Inject within one hour before the first meal of the day, in the abdomen, thigh or upper arm, rotating sites.
- Soliqua is dosed in insulin units, with the lixisenatide amount fixed by the ratio; its own label governs.
Pivotal trials and their numbers
| Trial | Population and duration | Result | PubMed |
|---|---|---|---|
| GetGoal-Mono | Adults with type 2 diabetes not on glucose-lowering drugs, mean HbA1c 8.0%; 12 weeks | Placebo-adjusted HbA1c -0.54 (two-step titration) and -0.66 (one-step) points; 52.2% and 46.5% reached below 7% vs 26.8%; weight about -2 kg | 22432104 |
| ELIXA | 6,068 adults with type 2 diabetes and a recent acute coronary syndrome; median 25 months | Primary endpoint 13.4% vs 13.2%; hazard ratio 1.02 (0.89 to 1.17); non-inferior, not superior; no difference in heart-failure hospitalisation or death | 26630143 |
ELIXA established cardiovascular safety and nothing more, and that is the honest summary of lixisenatide's outcome data.
Adverse reactions from the label
| Adverse reaction | Placebo % | Adlyxin % |
|---|---|---|
| Nausea | 6 | 25 |
| Vomiting | 2 | 10 |
| Headache | 6 | 9 |
| Diarrhea | 6 | 8 |
| Dizziness | 4 | 7 |
Gastrointestinal adverse reactions of any kind occurred in 39.7% on Adlyxin against 18.4% on placebo.
Boxed warning
None. Like Byetta, and unlike every long-acting agent on this site, Adlyxin has no thyroid C-cell boxed warning. Its warnings section covers hypersensitivity, pancreatitis, hypoglycemia with insulin or secretagogues, acute kidney injury, and severe gastrointestinal reactions.
Status and manufacturer
Sanofi holds both applications. Adlyxin is listed as a prescription product in Drugs@FDA with a 2026 label; Soliqua 100/33 is marketed. If your pharmacist cannot source Adlyxin, that reflects supply rather than the FDA record.
Where next
The exenatide entry covers the other exendin-4 drug and why its products were discontinued. For what "short-acting" and "long-acting" mean across the class, see the glossary.
Questions people ask
What does short-acting mean for a GLP-1 drug?
Lixisenatide's effect on gastric emptying and post-meal glucose is strongest for the meal after the injection and fades over the day, unlike liraglutide or the weekly agents, whose levels stay steady. The label's GetGoal-Mono result shows the pattern: a large drop in 2-hour post-meal glucose with a modest HbA1c change.
Is lixisenatide used for weight loss?
No. Its only indication is glycemic control in adults with type 2 diabetes, and the trials reported about 2 kg of weight change. It is on this site because it is an approved GLP-1 receptor agonist, not because it competes with the weight-management agents.
Sources
- Drugs@FDA: BLA 208471 Adlyxin (approval 2016-07-27; label supplement 12 approved 2026-03-12) Accessed September 4, 2026.
- Drugs@FDA: BLA 208673 Soliqua 100/33 (approval 2016-11-21) Accessed September 4, 2026.
- Adlyxin prescribing information, FDA-approved label March 2026 (BLA 208471 s012) Accessed September 4, 2026.
- Fonseca VA et al. Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy (GetGoal-Mono). Diabetes Care 2012. PubMed 22432104 Accessed September 4, 2026.
- Pfeffer MA et al. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome (ELIXA). N Engl J Med 2015. PubMed 26630143 Accessed September 4, 2026.
Canonical URL: https://formblendsglp1s.com/agents/lixisenatide. Written by the FormBlends editorial team. This page is educational and is not medical advice; see the medical disclaimer.