ApprovedWeight lossSubcutaneousEvidence 4/5

Lixisenatide

Also known as: Adlyxin, Lyxumia

Lixisenatide is an exendin-4-derived GLP-1 receptor agonist that slows gastric emptying and lowers postprandial glucose while stimulating glucose-dependent insulin release and suppressing glucagon.

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This page is a structured profile. Narrative evidence, dosing context and FAQs live on the research guide — not duplicated here as a second full article.

Illustrative profileSubcutaneous

Database profileApproved

LixisenatideWeight loss

Drug class: Short-acting (prandial) GLP-1 receptor agonist; exendin-4-derived peptide
Primary targets: GLP-1 receptor (GLP-1R)
Dose reference: Reference (Adlyxin label, not a recommendation): 10 mcg once daily subcutaneously for 14 days, then 20 mcg once daily maintenance, injected within one hour before the first meal.
Half-life: Approximately 3 hours (reported range ~2.7-4.3 hours)
Developer / origin: Discovered by Zealand Pharma; developed and marketed by Sanofi (Sanofi-Aventis)
Reference year: 2016
Evidence score: 4/5 - Approved drug with neutral cardiovascular outcomes; modest glycemic, not weight-loss, indication

Evidence 4/5

Approved drug with neutral cardiovascular outcomes; modest glycemic, not weight-loss, indication

Lixisenatide is FDA- and EMA-approved for type 2 diabetes based on the GetGoal phase 3 program, with the ELIXA cardiovascular outcomes trial establishing cardiovascular safety (non-inferiority) but not benefit. It was not approved as a weight-loss drug, and the standalone US product was discontinued in 2023.

Investigational compound with human randomized or phase 2/3 evidence.

Evidence basis

FDA Adlyxin prescribing information (initial U.S. approval July 27, 2016)
ELIXA randomized trial of 6,068 patients (NEJM 2015;373:2247-2257): primary CV composite 13.4% lixisenatide vs 13.2% placebo, non-inferior, not superior, heart-failure neutral
GetGoal phase 3 program: modest HbA1c reduction with predominant postprandial glucose effect
Pharmacology: exendin-4-derived 44-amino-acid peptide, ~3 hour half-life, once-daily prandial dosing

Key references

FDAAdlyxin (lixisenatide) FDA prescribing information
New England Journal of MedicineLixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome (ELIXA), N Engl J Med 2015
ClinicalTrials.govEvaluation of Cardiovascular Outcomes... AVE0010 (Lixisenatide) (ELIXA)
PMC / Diabetes TherapyThe Clinical Development Program of Lixisenatide

How to read this entry

Dose references and half-life values are pulled from trial protocols, labels, reviews, or published summaries where available. They are context for research and comparison, not a personal dosing recommendation.

Status matters: approved drugs have regulated indications; investigational compounds are still being studied; research-only peptides do not have established human dosing, safety, or efficacy for consumer use.