Lixisenatide
Also called Adlyxin.
Lixisenatide has FDA-approved products for specific uses. This page cites 2 sources, and the strongest evidence comes from human trials.
- Status
- FDA-approved product exists
- Form
- Pen injection
- Half-life
- Not modeled
- Strongest evidence
- Human trials
- Cited claims
- 2
- Last updated
- November 6, 2026
What the evidence says
Each claim names the kind of study behind it, what it can't tell you, and where it comes from.
Human trials
GetGoal-Mono found that once-daily subcutaneous lixisenatide improved HbA1c and post-meal glucose versus placebo over 12 weeks in 361 adults with type 2 diabetes not taking glucose-lowering medicines.
Limits: This short monotherapy trial does not establish long-term outcomes or the effects of insulin-glargine combinations. Weight decreased in all groups, so the glucose findings do not establish weight-loss superiority.
Human trials
ELIXA found cardiovascular noninferiority, without superiority, when lixisenatide was added to usual care in adults with type 2 diabetes and a recent acute coronary syndrome.
Limits: The population had recent coronary events. This trial supports its prespecified cardiovascular safety comparison, not a cardiovascular prevention benefit or a conclusion that every GLP-1 medicine produces the same outcomes.
Regulatory status
United States
Adlyxin is an FDA-approved subcutaneous lixisenatide product for adults with type 2 diabetes, alongside diet and exercise. FDA lists both Adlyxin pen presentations as discontinued, with February 22, 2023 entry dates. A later label revision does not itself establish renewed marketing or pharmacy availability.
United States
Soliqua 100/33 is a separate FDA-approved subcutaneous combination of insulin glargine and lixisenatide for adults with type 2 diabetes, alongside diet and exercise. It includes basal insulin and is not a brand alias for lixisenatide alone. It has its own instructions and risks.