Scientific context only. Not medical advice, not a recommendation to use.
At a glance
Synthetic exendin-4 analog with a C-terminal lysine extension. Prandial GLP-1 RA focused on postprandial glucose. FDA-approved 2016 as Adlyxin; EMA-approved 2013 as Lyxumia. Sanofi discontinued US distribution in 2023.
Researched for
Glycaemic control in type 2 diabetes (especially postprandial)Cardiovascular outcomes after acute coronary syndrome (ELIXA)
Official status
US: Unapproved
Originally FDA-approved 2016 as Adlyxin. Sanofi discontinued US distribution in 2023 — no active US marketing anymore.
Lixisenatide is a 44-amino-acid peptide based on exendin-4 (see exenatide) with six additional lysine residues at the C-terminus. This modification increases stability against DPP-4 degradation. The short half-life (~3 hours) and plasma peak around mealtime explain the predominantly prandial effect — stronger postprandial glucose action, weaker fasting glucose effect than weekly GLP-1 RAs.
02
Evidence at a glance
Reading note. The distribution shows on which evidence tier each observation sits. Strong colours mark stronger evidence — weaker tiers are deliberately visible, not hidden.
3 observations · single evidence tier
Human RCT
3
03
What the studies show
Human RCT
Mensch
Rosenstock J. et al. 2013
Reduction of postprandial glucose stronger than with weekly GLP-1 RAs documented across several GetGoal trials
What does NOT follow: Overall HbA1c reduction smaller than with liraglutide, semaglutide or tirzepatide.
Human RCT
Mensch
Pfeffer MA. et al. 2015
Neutral cardiovascular effect in type-2-diabetes patients with recent acute coronary syndrome in the ELIXA trial
What does NOT follow: No MACE reduction (HR 1.02 vs placebo); unlike LEADER (liraglutide) and SUSTAIN-6 (semaglutide). First CVOT for a GLP-1 RA with a neutral outcome.
Human RCT
Mensch
Weight loss as a secondary endpoint reported in the GetGoal trials — smaller than with weekly GLP-1 RAs
What does NOT follow: Secondary endpoint; clinical relevance for obesity treatment not established in dedicated trials.
04
Where studies disagree
Open question
Why is the cardiovascular effect of lixisenatide neutral, while other GLP-1 RAs show significant MACE reduction?
POSITION A
ELIXA showed HR 1.02 — no significant MACE reduction.
POSITION B
LEADER (liraglutide), SUSTAIN-6 and SELECT (semaglutide), REWIND (dulaglutide) all showed significant MACE reductions.
CURRENT STATE · The role of the short half-life (prandial vs constant exposure) and the study population (post-ACS patients with particularly high risk and short follow-up) is debated. Current consensus: the pharmacokinetic profile appears less cardiovascularly favourable.
05
Pharmacokinetics
Theoretical concentration curve at a half-life of 3 h. Pure pharmacokinetic model — not a dosing recommendation.
Which routes of administration the available studies describe — neutral reporting, not a usage guide.
Subcutaneous
In ELIXA and the GetGoal trials administered exclusively daily subcutaneously before a main meal.
07
Known adverse events from studies
Factual reporting of what studies observed. Not a safety statement for individual use.
Human RCT
Nausea
Most frequent documented event in the GetGoal trials.
häufig in Titration
07b
Interactions & combinations
Documented interactions and contraindications from studies, prescribing information and guidelines. Where no data exists, this is stated.
Reporting of risks, NOT a combination guide. The absence of an entry does not mean „safe to combine“ but „not sufficiently studied“.
No documented interactions recorded
We have not yet found robustly documented interactions for this peptide. This does NOT mean none exist — the data is limited.
11
Legal status by country
Country
Status
Note
Checked
United States
Unapproved
Originally FDA-approved 2016 as Adlyxin. Sanofi discontinued US distribution in 2023 — no active US marketing anymore.
2026-05-22
Germany
Prescription
EMA-approved 2013 as Lyxumia. Prescription-only in Germany.
2026-05-22
JP
Prescription
Approved in Japan for type 2 diabetes.
2026-05-22
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Reconstitution calculator
Pure mg/mL maths — works like a calculator. Not a usage recommendation.
Peptides ship as a dry powder. Once dissolved in a liquid (reconstitution), this calculator answers a single question: how much substance is in one millilitre of solution afterwards?
1Enter the vial's substance amount (printed on the label).
2Enter how much solvent you add.
3Result = concentration in mg per mL.
Printed on the label
/
Liquid you add
=
2.50
mg / mL
5 mg in 2 mL gives 2.50 mg/mL — each millilitre contains 2.50 mg of substance.
Efficacy and safety of lixisenatide once-daily morning administration in patients with type 2 diabetes inadequately controlled with diet and exercise (GetGoal-Mono)