Lixisenatide

Adlyxin (US), Lyxumia (EU and elsewhere), AVE0010, ZP10A; component of Soliqua / Suliqua (with insulin glargine)

Metabolic & weight

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Note on this profile. Lixisenatide is an approved prescription medicine for type 2 diabetes in many countries, not a research-only compound. This page explains the published science, including its 2024 Parkinson's disease trial. Use outside a prescription carries real risks discussed below.

Summary

Class: GLP-1 receptor agonist; 44-amino-acid synthetic analogue of exendin-4 with one proline removed and six lysines added at the C-terminus
Mechanism: Activates the GLP-1 receptor with a pronounced slowing of gastric emptying, so its main effect is on post-meal glucose; also reduces appetite
Routes studied: Subcutaneous once daily, within an hour before the first meal of the day; also as a fixed-ratio combination with insulin glargine
Dose range reported: Approved: 10 µg once daily for 14 days, then 20 µg once daily. Parkinson's trial (LixiPark) used the same titration to 20 µg daily, off-label
Half-life: ~3 hours; classed as a "short-acting" GLP-1 agonist despite once-daily dosing because receptor exposure is intermittent
Storage: Unopened: refrigerate. In-use pen: room temperature (below 30 °C), discard 14 days after first use
Regulatory status: Approved for type 2 diabetes (EU 2013, US 2016 and others). US stand-alone product discontinued commercially in 2023 †; the glargine combination remains

Doses are as reported in studies or by the community — never recommendations.

1What it is

Lixisenatide was discovered by Zealand Pharma in Denmark and developed by Sanofi. Structurally it is exendin-4 (the Gila monster peptide behind exenatide) with a tail of six lysine residues, which slows its breakdown. It is dosed once daily but has a short , so its pharmacology is dominated by the slowing of stomach emptying after the meal it precedes. In practice that makes it a good partner for a long-acting basal insulin, which controls fasting glucose but not meals — hence the combination product Soliqua (US) / Suliqua (EU), which is now the main way lixisenatide is used.

Sanofi withdrew the stand-alone Adlyxin from the US market in 2023 for commercial reasons, not safety †, and it has a small market share elsewhere. It would be a footnote among GLP-1 drugs were it not for the LixiPark trial in Parkinson's disease, which reported a positive result in 2024.

2How it's thought to work

Gastric emptying. the dominant effect at approved doses; delays the arrival of glucose from the meal, flattening the post-meal spike. The effect does not fade as much as with continuously-acting because exposure is intermittent.

Pancreas. glucose-dependent insulin release and glucagon suppression.

Appetite. modest; weight loss is small (1–2 kg).

Brain. lixisenatide crosses into the brain in rodent models more readily than some larger agonists. In mouse models of Parkinson's it protected dopamine-producing neurons and reduced motor deficits (Liu 2015, Neuroscience), which motivated the human trial.

A short-acting GLP-1 receptor agonist taken once daily. Its strongest effect is on stomach emptying, which is why it targets after-meal glucose rather than fasting glucose.Schematic — not to scale

3What the research shows

Glucose control in type 2 diabetes

The GetGoal programme (over a dozen trials) showed HbA1c reductions of about 0.5–0.9 percentage points vs placebo, with strong effects on post-meal glucose, and weight change of roughly −1 to −2 kg (e.g. Fonseca 2012, Diabetes Care, GetGoal-Mono; Riddle 2013, Diabetes Care, GetGoal-L — added to basal insulin). Head-to-head with exenatide twice daily (GetGoal-X), lixisenatide was non-inferior with less nausea and hypoglycaemia (Rosenstock 2013, Diabetes Care). [3][4][5]

Fixed-ratio combination with insulin glargine

LixiLan-O and LixiLan-L showed the combination lowers HbA1c more than either component alone with less weight gain and no more hypoglycaemia than glargine (Rosenstock 2016; Aroda 2016 — both Diabetes Care). [6]

Graded A (neutral)

Cardiovascular outcomes

ELIXA (n=6,068 with type 2 diabetes and a recent acute coronary syndrome) found lixisenatide neither increased nor reduced major adverse cardiovascular events over a median 25 months (hazard ratio 1.02; Pfeffer 2015, NEJM). It was the first GLP-1 cardiovascular outcome trial and established safety, not benefit. [1]

Graded A (one phase 2)

Parkinson's disease

LixiPark (n=156, early Parkinson's, diagnosed <3 years, on stable dopaminergic therapy) randomised people to lixisenatide 20 µg daily or placebo for 12 months. Motor scores (MDS-UPDRS part 3) worsened by 3.04 points in the placebo group and were unchanged (−0.04) with lixisenatide, a difference of about 3 points (Meissner 2024, NEJM). The difference persisted at a 2-month . Nausea affected 46% and vomiting 13%, and the effect size is modest and of uncertain clinical meaning. It is the first positive placebo-controlled GLP-1 result in Parkinson's since the 2017 exenatide study, and it arrived shortly before the larger exenatide phase 3 reported negative (see profile 61). A larger, longer trial is needed before any claim of disease modification. [2]

Graded A (small effect)

Weight management

Weight loss in diabetes trials is small. There are no obesity trials and no approval for weight management.

4Reported side effects and interactions

Literature-reported

Literature (common). nausea (~25% in diabetes trials, 46% in LixiPark), vomiting, diarrhoea, headache, dizziness; symptomatic hypoglycaemia when combined with sulfonylureas or insulin.

Serious / label warnings. pancreatitis (rare); serious hypersensitivity reactions including anaphylaxis; acute kidney injury from dehydration; not recommended with severe gastroparesis; not studied in end-stage kidney disease. Unlike the longer-acting , the US label for lixisenatide does not carry the rodent thyroid C-cell boxed warning †, although it shares class cautions. Anti-drug antibodies develop in a majority of users (~70%) and high titres can blunt the glucose effect.

Community-reported

essentially none; interest in the Parkinson's finding is the main driver of searches.

Interactions. pronounced slowing of gastric emptying means oral medicines that need rapid absorption (antibiotics, acetaminophen/paracetamol, oral contraceptives) are advised to be taken at least 1 hour before or 11 hours after the injection; hypoglycaemia with insulin or sulfonylureas.

Markers researchers commonly monitor

Following the approved-label monitoring and trial protocols:

Marker	Why it's watched
HbA1c, fasting and post-meal glucose	the post-meal reading is where this agonist acts most.
eGFR and creatinine	dehydration-related kidney injury is a labelled risk.
Weight	small changes expected; useful as a tolerance and adherence check.
Lipase/amylase	only if persistent abdominal pain.
Heart rate	small increases, as with the class.
Hypoglycaemia log	particularly when combined with insulin or sulfonylureas.
In the Parkinson's research context: MDS-UPDRS motor scores and levodopa-equivalent daily dose are the trial outcome measures; these are clinical assessments, not self-tests

Free for everyone. Safety information is never behind a paywall.

5Reconstitution and handling

Pre-filled multi-dose pens (green 10 µg starter pen, purple 20 µg maintenance pen) need no ; prime a new pen once. Soliqua/Suliqua pens deliver insulin glargine and lixisenatide in a fixed ratio and are dosed in insulin units. These are not research vials and the calculator does not apply.

Open in calculator, pre-loaded →

6Commonly studied alongside

Insulin glargine (the fixed-ratio combination), metformin, sulfonylureas, pioglitazone. In the neurodegeneration field: exenatide, liraglutide and semaglutide (the broader GLP-1-in-Parkinson's effort).

Informational cross-links. Not stack recommendations.

7Regulatory status by region

Region	Status (checked —)
United States	FDA-approved 2016 (Adlyxin) for type 2 diabetes; stand-alone product discontinued by Sanofi in January 2023 for commercial reasons †. Soliqua 100/33 (with insulin glargine) remains approved
European Union	EMA-authorised 2013 (Lyxumia); Suliqua authorised 2017. Availability of stand-alone Lyxumia varies by country †
United Kingdom	MHRA-licensed; prescription-only; stand-alone availability †
Australia	TGA-registered (Lyxumia) †
South Africa	SAHPRA registration status †
Sport	Not prohibited by WADA (GLP-1 agonists not listed as of 2026 †)

8Open questions

Will the LixiPark motor benefit hold in a longer, larger phase 3, given that exenatide's did not?
Is the Parkinson's effect specific to that penetrate the brain well, and is the nausea burden acceptable for a long-term neuroprotective use?
The practical future of the stand-alone product, now that it has been withdrawn in the US.

9References

1Pfeffer MA et al. (2015). Lixisenatide in patients with type 2 diabetes and acute coronary syndrome (ELIXA). NEJM. PubMed · DOI
2Meissner WG et al. (2024). Trial of lixisenatide in early Parkinson's disease (LixiPark). NEJM. PubMed · DOI
3Fonseca VA et al. (2012). Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy (GetGoal-Mono). Diabetes Care. DOI
4Riddle MC et al. (2013). Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin (GetGoal-L). Diabetes Care. PubMed · DOI
5Rosenstock J et al. (2013). Efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled on metformin (GetGoal-X). Diabetes Care. PubMed · DOI
6Rosenstock J et al. (2016). Benefits of LixiLan, a titratable fixed-ratio combination of insulin glargine plus lixisenatide, versus insulin glargine and lixisenatide monocomponents in type 2 diabetes inadequately controlled on oral agents (LixiLan-O). Diabetes Care. PubMed · DOI
7Liu W et al. (2015). Neuroprotective effects of lixisenatide and liraglutide in the 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine mouse model of Parkinson's disease. Neuroscience. PubMed · DOI
8Sanofi. Adlyxin / Lyxumia and Soliqua / Suliqua prescribing information (current labels). PubMed

References are being resolved to PubMed/DOI identifiers; links search PubMed for the citation until then.

† Being confirmed by our reviewers against current sources.

10Community

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Self-reported side effects Phase 2

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11Page history

26 Oct 2026Profile published — awaiting medical review

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