Source: FDA label
| Molecular formula | C215H347N61O65S |
|---|---|
| Molecular weight | 4858 g/mol |
| Registered trials | 79 |
| 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
Key takeaways
- Lixisenatide is a GLP-1 receptor agonist combined with insulin glargine in the approved product Soliqua 100/33.
- It is indicated as an adjunct to diet and exercise for glycemic control in adults with type 2 diabetes.
- The combination is not recommended with other GLP-1 receptor agonist products or for diabetic ketoacidosis.
- More than 75 registered trials have studied lixisenatide, including completed phase 3 and phase 4 studies.
- FAERS reports for products containing lixisenatide most often involve blood glucose changes and product handling issues, not necessarily drug-caused effects.
What Lixisenatide Is
Lixisenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist. In the approved product Soliqua 100/33, it is paired with insulin glargine, a long-acting insulin analog. Insulin glargine lowers blood glucose by promoting glucose uptake into muscle and fat tissue and by reducing glucose production in the liver. Insulin also suppresses the breakdown of fat and protein. Lixisenatide works through the GLP-1 receptor pathway, complementing insulin's glucose-lowering action.
What Lixisenatide Is Approved For
Soliqua 100/33, the combination of insulin glargine and lixisenatide, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The label states that combining this product with another GLP-1 receptor agonist is not recommended. It is also not recommended for treating diabetic ketoacidosis, and it has not been studied alongside prandial insulin. The current label does not carry a boxed warning.
What the Evidence Shows
Lixisenatide has been studied in more than 75 registered clinical trials. One completed phase 3 trial assessed its efficacy and safety in patients with type 2 diabetes who had insufficient control on basal insulin, with or without metformin. A separate completed phase 4 trial examined the combination product alongside sulfonylurea as an add-on to basal insulin in patients who chose to fast during Ramadan. Another completed phase 3 trial compared the iGlarLixi combination against IDegAsp in participants in China following oral antidiabetic drugs.
Reported Side Effects
Reports submitted to FAERS for lixisenatide-containing products most frequently describe increases in blood glucose, with 467 reports. A substantial share of reports relate to product handling rather than a direct drug effect, including storage errors (402), off-label use (355), accidental exposure to the product (340), exposure via skin contact (203), and inappropriate dosing schedules (149). Gastrointestinal and visual symptoms were also reported, including nausea (154) and visual impairment (146). These figures reflect the number of reports submitted, not confirmed incidence or a proven causal link to the drug.
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.
How does lixisenatide work?
Lixisenatide acts on the GLP-1 receptor pathway and is combined with insulin glargine, a basal insulin analog. Insulin glargine lowers blood glucose by increasing glucose uptake in muscle and fat and reducing glucose production in the liver.
Can lixisenatide be combined with other GLP-1 medicines?
No. The label for Soliqua 100/33 states that concomitant use with any other product containing a GLP-1 receptor agonist is not recommended.
What are the most commonly reported side effects with lixisenatide-containing products?
FAERS reports most frequently mention increased blood glucose, along with product storage errors, off-label use, and accidental exposure. Nausea and visual impairment were also reported. These are counts of submitted reports, not confirmed rates of occurrence.
Has lixisenatide been studied in clinical trials?
Yes, more than 75 trials have been registered involving lixisenatide, including completed phase 3 and phase 4 studies. These include trials in patients with type 2 diabetes insufficiently controlled on basal insulin and studies comparing combination therapies.
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Content is editorial information, not medical advice. Talk to your doctor before any treatment decision.
Sources: DailyMed label (Soliqua 100/33) ClinicalTrials.gov FDA Adverse Event Reporting System (FAERS) PubChem CID 90472060
Updated 2026-11-07