Source: FDA label
| Molecular formula | C215H347N61O65S |
|---|---|
| Molecular weight | 4858 g/mol |
| Registered trials | 77 |
| PubChem CID | 90472060 |
| Drug class | Insulin Analog [EPC] |
| Brand names | Soliqua 100/33 |
Mechanism of Action
12.1 Mechanism of Action SOLIQUA 100/33 SOLIQUA 100/33 is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. Insulin glargine The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis and enhanc
Managing blood sugar in type 2 diabetes often means combining more than one type of medicine, and lixisenatide is part of one such combination approach. It works alongside a long-acting insulin to help adults with type 2 diabetes reach glycemic targets when diet and exercise are not enough on their own.
Key takeaways
- Lixisenatide is the GLP-1 receptor agonist component of Soliqua 100/33, paired with insulin glargine.
- It is approved as an adjunct to diet and exercise for glycemic control in adults with type 2 diabetes.
- The label carries no boxed warning.
- More than 75 registered trials have studied lixisenatide, including dose-ranging and mechanistic studies.
- FDA safety reports most often mention blood glucose changes and product handling issues rather than classic drug side effects.
What Lixisenatide Is
Lixisenatide belongs to a drug class called GLP-1 receptor agonists, used here alongside insulin glargine, a basal insulin analog. In the combination product Soliqua 100/33, insulin glargine lowers blood glucose by promoting glucose uptake into muscle and fat tissue while reducing glucose production in the liver. Lixisenatide contributes GLP-1 receptor activity, working through a separate pathway to support blood sugar regulation.
What Lixisenatide Is Approved For
Lixisenatide is approved in the United States only as part of Soliqua 100/33, sold under that single brand name. This combination of insulin glargine and lixisenatide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The label specifies that it should not be combined with other GLP-1 receptor agonist products, is not recommended for diabetic ketoacidosis, and has not been studied alongside prandial insulin. No boxed warning appears on this label.
What the Evidence Shows
Lixisenatide has been studied across more than 75 registered clinical trials. An early phase 2 dose-ranging study examined the GLP-1 agonist in metformin-treated adults with type 2 diabetes and reached completed status. A phase 1 trial compared its effects on gastroesophageal reflux, gastric emptying, and gastric acid secretion against another GLP-1 therapy, though that study was terminated. A more recent phase 4 study has explored its effect on pituitary hormones, with status currently unknown.
Reported Side Effects
Reports submitted to the FDA's adverse event system are counts of reported reactions, not confirmed rates of incidence or proof that the drug caused the event. The most frequently reported terms relate to blood glucose changes and product use: increased blood glucose (460 reports), product storage errors (400), and off-label use (325). Reports of accidental exposure and skin contact with the product were also common (323 and 186, respectively), alongside nausea (151), inappropriate dosing schedules (146), and visual impairment (145).
FAQ
What is lixisenatide used for?
Lixisenatide is the GLP-1 receptor agonist component of Soliqua 100/33, a combination product with insulin glargine. It is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Is lixisenatide sold on its own?
Based on the available label data, lixisenatide is approved in the United States only within the combination product Soliqua 100/33, alongside insulin glargine. No standalone brand name is listed in this data.
Does lixisenatide have a boxed warning?
No, the label for Soliqua 100/33, which contains lixisenatide, does not carry a boxed warning.
What are the most commonly reported side effects with lixisenatide?
FDA adverse event reports most frequently mention increased blood glucose, product storage errors, and off-label use, followed by accidental exposure, skin contact, nausea, dosing schedule errors, and visual impairment. These are counts of submitted reports, not confirmed rates of incidence or proof of causation.
What clinical research has been done on lixisenatide?
More than 75 clinical trials have been registered involving lixisenatide, spanning early dose-ranging studies in people with type 2 diabetes to more recent research on pituitary hormone effects. Trial statuses in the available sample range from completed to terminated to unknown.
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Content is editorial information, not medical advice. Talk to your doctor before any treatment decision.
Sources: FDA label (DailyMed) for Soliqua 100/33 ClinicalTrials.gov trial registry FDA Adverse Event Reporting System (FAERS) PubChem CID 90472060
Updated 2026-08-10