Approved & therapeutic
Lixisenatide
Adlyxin
Lixisenatide is a short-acting GLP-1 receptor agonist approved in the US for glycemic control in adults with type 2 diabetes, with a pronounced effect on postprandial glucose. The standalone product Adlyxin was discontinued in the US in January 2023; the molecule now reaches US patients only as a component of the fixed-ratio combination Soliqua 100/33 with insulin glargine, so that product's label governs real-world use.
- Status
- Lixisenatide is approved by the U.S. FDA and has official prescribing information.
- Evidence
- Approved labeling. Official prescribing information exists, based on clinical trials in people.
- Half-life
- Mean terminal half-life approximately 3 hours.
- How it's taken
- Subcutaneous injection.
- Mechanism
- Incretin (GLP-1 / GIP / glucagon / amylin)
- Pathways
- GLP-1
How Lixisenatide works
Lixisenatide is an exendin-4 analog that agonizes the GLP-1 receptor, increasing glucose-dependent insulin secretion, suppressing elevated glucagon, and markedly slowing gastric emptying. Its short half-life and strong gastric-emptying effect bias its action toward blunting the post-meal glucose rise rather than lowering fasting glucose.
What research has looked at
- Improved HbA1c and, particularly, postprandial glucose as an adjunct to diet and exercise in adults with type 2 diabetes. Note that the lower starting dose is a tolerability step and the label states it is not effective for glycemic control.
- Cardiovascular safety was demonstrated but no cardiovascular benefit was shown: in the ELIXA outcomes trial of 6,068 people with type 2 diabetes and a recent acute coronary syndrome, followed for a median of about 25 months, a primary composite endpoint event occurred in 406 patients (13.4 percent) on lixisenatide versus 399 (13.2 percent) on placebo, hazard ratio 1.02 (95 percent CI 0.89 to 1.17). This was a null primary endpoint, not a benefit.
- Modest weight reduction has been reported in type 2 diabetes trials; weight loss is not an approved indication and is not a labeled efficacy claim.
- Its complementary profile to basal insulin, which mainly addresses fasting glucose, was the rationale for the fixed-ratio combination with insulin glargine.
Evidence level: Approved labeling. Official prescribing information exists, based on clinical trials in people. These are areas studied or reported, not promised effects.
Reported side effects and risks
- Contraindicated in known severe hypersensitivity to lixisenatide or any component; anaphylaxis and other serious hypersensitivity reactions including angioedema have been reported in clinical trials at a frequency of about 0.1 percent. Discontinue and seek medical attention promptly if a reaction occurs.
- Acute pancreatitis, including fatal and non-fatal hemorrhagic and necrotizing pancreatitis, has been observed with GLP-1 receptor agonists. Discontinue promptly if pancreatitis is suspected and do not restart if confirmed.
- Never share a lixisenatide pen between patients, even if the needle is changed — pen-sharing poses a risk for transmission of blood-borne pathogens.
- Hypoglycemia, including severe hypoglycemia, when used with insulin or insulin secretagogues. Symptomatic hypoglycemia occurred in 14.5 percent on lixisenatide versus 10.6 percent on placebo with a sulfonylurea, 28.3 percent versus 23.0 percent with basal insulin, and 47.2 percent versus 21.6 percent with basal insulin plus a sulfonylurea.
- Acute kidney injury due to volume depletion, in some cases requiring hemodialysis, reported postmarketing with GLP-1 receptor agonists — most events occurred in patients with gastrointestinal reactions leading to dehydration. Not recommended in end-stage renal disease.
- Severe gastrointestinal adverse reactions; not recommended in patients with severe gastroparesis. Gastrointestinal reactions occurred in 39.7 percent on lixisenatide versus 18.4 percent on placebo, and 4.3 percent versus 0.5 percent discontinued because of them.
- Acute gallbladder disease — in ELIXA, cholelithiasis occurred in 0.4 percent versus 0.2 percent and acute cholecystitis in 0.3 percent versus 0.2 percent on placebo.
- Most common adverse reactions (at least 5 percent) were nausea (25 percent versus 6 percent on placebo), vomiting (10 percent versus 2 percent), headache, diarrhea, dizziness, and hypoglycemia.
- Anti-lixisenatide antibodies are a labeled immunogenicity concern — 70 percent were antibody positive at Week 24, and an attenuated glycemic response was seen in the small proportion with the highest antibody concentrations. Delayed gastric emptying can reduce absorption of concomitant oral medications, and pulmonary aspiration during general anesthesia or deep sedation is a labeled precaution.
- Because the only marketed US lixisenatide product is the fixed-ratio combination Soliqua 100/33, that product's additional labeled contraindication also applies in practice: do not use during episodes of hypoglycemia. Its insulin-related warnings apply as well — hypokalemia, overdose due to medication errors from mixing up insulin products, fluid retention and heart failure when used with PPAR-gamma agonists, and hyperglycemia or hypoglycemia with changes in insulin regimen.
Sources
- PubMed research on Lixisenatide · NIH · National Library of Medicine
- DrugBank record for Lixisenatide · DrugBank
- Active clinical trials for Lixisenatide · U.S. National Library of Medicine
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Lixisenatide FAQ
What is Lixisenatide?
Lixisenatide is a short-acting GLP-1 receptor agonist approved in the US for glycemic control in adults with type 2 diabetes, with a pronounced effect on postprandial glucose. The standalone product Adlyxin was discontinued in the US in January 2023; the molecule now reaches US patients only as a component of the fixed-ratio combination Soliqua 100/33 with insulin glargine, so that product's label governs real-world use.
How does Lixisenatide work?
Lixisenatide is an exendin-4 analog that agonizes the GLP-1 receptor, increasing glucose-dependent insulin secretion, suppressing elevated glucagon, and markedly slowing gastric emptying. Its short half-life and strong gastric-emptying effect bias its action toward blunting the post-meal glucose rise rather than lowering fasting glucose.
Is Lixisenatide FDA approved?
Yes. Lixisenatide is approved by the U.S. FDA and has official prescribing information. Evidence level: approved labeling. Official prescribing information exists, based on clinical trials in people.
What is the half-life of Lixisenatide?
Reported half-life: Mean terminal half-life approximately 3 hours.
How is Lixisenatide taken?
Subcutaneous injection.
What side effects have been reported with Lixisenatide?
Reported in the sources: Contraindicated in known severe hypersensitivity to lixisenatide or any component; anaphylaxis and other serious hypersensitivity reactions including angioedema have been reported in clinical trials at a frequency of about 0.1 percent. Discontinue and seek medical attention promptly if a reaction occurs; Acute pancreatitis, including fatal and non-fatal hemorrhagic and necrotizing pancreatitis, has been observed with GLP-1 receptor agonists. Discontinue promptly if pancreatitis is suspected and do not restart if confirmed; Never share a lixisenatide pen between patients, even if the needle is changed — pen-sharing poses a risk for transmission of blood-borne pathogens; Hypoglycemia, including severe hypoglycemia, when used with insulin or insulin secretagogues. Symptomatic hypoglycemia occurred in 14.5 percent on lixisenatide versus 10.6 percent on placebo with a sulfonylurea, 28.3 percent versus 23.0 percent with basal insulin, and 47.2 percent versus 21.6 percent with basal insulin plus a sulfonylurea; Acute kidney injury due to volume depletion, in some cases requiring hemodialysis, reported postmarketing with GLP-1 receptor agonists — most events occurred in patients with gastrointestinal reactions leading to dehydration. Not recommended in end-stage renal disease; Severe gastrointestinal adverse reactions; not recommended in patients with severe gastroparesis. Gastrointestinal reactions occurred in 39.7 percent on lixisenatide versus 18.4 percent on placebo, and 4.3 percent versus 0.5 percent discontinued because of them; Acute gallbladder disease — in ELIXA, cholelithiasis occurred in 0.4 percent versus 0.2 percent and acute cholecystitis in 0.3 percent versus 0.2 percent on placebo; Most common adverse reactions (at least 5 percent) were nausea (25 percent versus 6 percent on placebo), vomiting (10 percent versus 2 percent), headache, diarrhea, dizziness, and hypoglycemia; Anti-lixisenatide antibodies are a labeled immunogenicity concern — 70 percent were antibody positive at Week 24, and an attenuated glycemic response was seen in the small proportion with the highest antibody concentrations. Delayed gastric emptying can reduce absorption of concomitant oral medications, and pulmonary aspiration during general anesthesia or deep sedation is a labeled precaution; Because the only marketed US lixisenatide product is the fixed-ratio combination Soliqua 100/33, that product's additional labeled contraindication also applies in practice: do not use during episodes of hypoglycemia. Its insulin-related warnings apply as well — hypokalemia, overdose due to medication errors from mixing up insulin products, fluid retention and heart failure when used with PPAR-gamma agonists, and hyperglycemia or hypoglycemia with changes in insulin regimen.
Educational summary compiled from the sources listed above. Not medical advice. Peptide Vault does not sell, source or recommend any compound. Talk to a qualified clinician before starting or changing anything.