Lixisenatide (Adlyxin, Soliqua): the short-acting daily GLP-1

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-1GLP-1A gut hormone released after eating that raises insulin, slows the stomach and reduces appetite; the medicines copy it and last much longer. 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 emptyinggastric emptyingHow quickly food leaves the stomach; these medicines slow it, which is part of why people feel full sooner.. Like exenatide it is built on exendin-4, not on the human GLP-1 sequence. Its half-lifehalf-lifeThe time it takes for the amount of drug in the blood to fall by half; a week-long half-life is what allows once-weekly dosing. 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

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 subcutaneouslysubcutaneousInjected into the fat layer just under the skin, usually the abdomen, thigh or upper arm. 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 dosemaintenance doseThe dose you stay on after the step-up period ends. 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

ELIXA established cardiovascular safety and nothing more, and that is the honest summary of lixisenatide's outcome data.

Adverse reactions from the label

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-cellC-cellThyroid cells that make calcitonin; rodent studies of these medicines showed tumours in them, which is why the boxed warning exists. boxed warningboxed warningThe FDA's strongest label warning, printed in a box at the top; for these medicines it concerns thyroid C-cell tumours seen in rodents.. Its warnings section covers hypersensitivity, pancreatitispancreatitisInflammation of the pancreas, felt as severe upper-abdominal pain; the labels say to stop the medicine if it is suspected., hypoglycemiahypoglycemiaBlood sugar falling too low; uncommon with these medicines alone but more likely alongside insulin or a sulfonylurea. 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.