Lixisenatide

AApproved (Rx)GLP-1 and incretin agonists →AdlyxinLyxumiaAVE0010
In one paragraphLixisenatide is a short-acting GLP-1 receptor agonist derived from exendin-4, approved for type 2 diabetes since 2013 and now sold mainly in combination with insulin glargine. Its cardiovascular-outcomes trial in 6,068 people after a heart attack was neutral. In 2024 a French phase 2 trial found that a year of lixisenatide slowed motor progression in early Parkinson's disease by about three points on the standard scale, with nausea in nearly half. It is prescription-only; the standalone product has been withdrawn in some markets.
Schematic 3D structure of Lixisenatide
44 residues · exendin-4 analogue with a C-terminal hexalysine tail · schematic
Overall gradeA Established
Human trialsGetGoal programme; ELIXA (n=6,068); LIXIPARK (n=156)
Outcomes graded4
Last reviewed23 September 2026
EvidenceWhat it isHow it worksUnknownsMolecule & PKRegulationQuestionsReferences

What the human research shows

A settled diabetes medicine whose interesting evidence is off-label: the Parkinson's result is the most positive GLP-1 neuroprotection trial so far, and still a phase 2. Grades are A where the trials are large, B for the Parkinson's finding.

MetabolicCardioMuscleHealingNeuroImmuneSexualSkinAgeing

Evidence profile0–5

  • Metabolic & weightA3.3
  • CardiovascularA0.0
  • Muscle & growth—0.0
  • Healing & repair—0.0
  • Neuro & sleep—0.0
  • Immune & inflammation—0.0
  • Sexual & hormonal—0.0
  • Skin & appearance—0.0
  • Ageing & longevity—0.0
Each score is confidence × effect size, taken from the best-evidenced benefit in that domain: the grade (A–D) sets the confidence, the measured effect sets the size. Hover a domain to see the outcomes behind it. Adverse effects are excluded and listed separately below.
OutcomeGradeEffect sizeHuman studiesWhere the evidence comes from
Blood glucose (HbA1c)AEstablishedModerateGetGoal programme (10+ RCTs)Approval-grade HbA1c reductions as an add-on in type 2 diabetes, with a particular effect on post-meal glucose because of its short action.3
Major cardiovascular eventsAEstablishedNot measurable1 large RCT (ELIXA, n=6,068)In people with type 2 diabetes and a recent acute coronary syndrome, lixisenatide neither increased nor reduced major cardiovascular events — non-inferior to placebo, not superior. The first GLP-1 outcomes trial, and a neutral one.1
Motor progression in early Parkinson's diseaseBProbableSmall1 phase 2 RCT (n=156, 12 mo)LIXIPARK: motor scores were essentially unchanged on lixisenatide and worsened by three points on placebo over a year — a statistically clear but clinically modest difference, in a trial too small and short to establish disease modification.2
GI side effectsadverseAEstablishedModerateAll trialsThe class profile; in the Parkinson's trial, where participants were not diabetic, nausea affected almost half.2
AMultiple good human trials, consistentBSome human trials, mostly consistentCFew or weak human studiesDAnimal or anecdotal onlyeffect size · red = adverse

Literature searched to 23 September 2026. Human studies only; animal and cell work informs the mechanism section and nothing else.

Registered trials

ClinicalTrials.gov lists 62 interventional studies naming Lixisenatide as an intervention — 52 completed, 2 recruiting, and 27 with results posted to the registry.

A registration is not a result. Anyone can register a study, and many never report — so this list shows what has been attempted, not what has been shown. The graded evidence above is the answer to whether something works.

StudyPhaseStatusParticipantsSponsorResults
Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 DiabetesNCT01973231 · started Oct 2013Phase 4Completed404Novo Nordisk A/SPosted
Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes MellitusNCT05114590 · started Jan 2022Phase 4Completed124SanofiPosted
Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)NCT01147250 · started Jun 2010Phase 3Completed6,068SanofiPosted
Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DMNCT02058147 · started Feb 2014Phase 3Completed1,170SanofiPosted
Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic PatientsNCT01768559 · started Jan 2013Phase 3Completed894SanofiPosted
GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of SulfonylureaNCT00713830 · started Jul 2008Phase 3Completed859SanofiPosted
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 DiabetesNCT02058160 · started Jan 2014Phase 3Completed736SanofiPosted
GLP-1 Receptor Agonist Lixisenatide (Morning or Evening) in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of MetforminNCT00712673 · started Jun 2008Phase 3Completed680SanofiPosted

54 further studies are registered. Participant counts marked * are the sponsor's estimate, not a final enrolment. Source: ClinicalTrials.gov, read directly from the registry and refreshed weekly.

What it is

Lixisenatide is a 44-amino-acid exendin-4 analogue with a six-lysine tail, developed by Zealand Pharma and marketed by Sanofi as Lyxumia (EU, 2013) and Adlyxin (US, 2016). Its half-life is about three hours, so it is a once-daily prandial drug rather than a weekly one, and it has been overtaken commercially by the weekly agonists; the fixed combination with insulin glargine (Soliqua/Suliqua) is now the main product.

It earned a second life in neurology: the LIXIPARK trial is the first randomised evidence that a GLP-1 drug may slow Parkinson's progression, after exenatide's phase 3 in the same disease was negative.

How it is thought to work

In diabetes, the usual GLP-1 actions with an emphasis on slowing gastric emptying after meals. In Parkinson's the proposed mechanism is neuroprotection through GLP-1 receptors on neurons and glia — supported by animal models, and now by one phase 2, but not by the negative exenatide phase 3.

What is still unknown

  • Whether the Parkinson's effect holds in a larger, longer trial and whether it is disease modification or a symptomatic effect.
  • Why exenatide's phase 3 in Parkinson's was negative while lixisenatide's phase 2 was positive.

The molecule and how long it lasts

Identity
Formula
C215H347N61O65S
Molecular weight
4858 g/mol
CAS number
320367-13-3
PubChem
CID 90472060

PubChem record, read 23 September 2026.

Pharmacokinetics
Route
Subcutaneous injection, once daily before the first meal
Half-life
About 3 hours
Licensed regimen (Soliqua 100/33 (with insulin glargine))
Soliqua: 15–60 units of insulin glargine with 5–20 mcg lixisenatide once daily, titrated to glucose; standalone lixisenatide (Adlyxin) was 10 mcg daily for 14 days then 20 mcg daily

From the approved product's prescribing information: Soliqua 100/33 prescribing information (DailyMed) The regimen is the label's own wording, reproduced as a regulatory fact.

Regulatory status

European Union
Approved, prescription-only

Lyxumia authorised 2013; Suliqua (with insulin glargine) authorised 2017. Check availability of the standalone product, which Sanofi has discontinued in several markets.

United States
Approved, prescription-only

Adlyxin approved 2016; only the Soliqua combination is currently listed on DailyMed, the standalone product having been discontinued.

United Kingdom
Licensed, prescription-only

Lyxumia and Suliqua licensed by the MHRA.

Australia
Registered, Schedule 4

Registered as Lyxumia / Soliqua.

Canada
Authorised, prescription-only

Adlyxine and Soliqua.

Sport (WADA)
Not prohibited

GLP-1 receptor agonists are not on the Prohibited List.

Questions people actually ask

Does lixisenatide treat Parkinson's disease?
One phase 2 trial found slower motor decline over a year. That is promising and not proof; it is not approved for Parkinson's, and larger trials are needed.
Why is lixisenatide less used than semaglutide?
It is short-acting and once-daily, produces less weight loss, and its heart trial was neutral where semaglutide's was positive.
Is lixisenatide a peptide?
Yes — a 44-amino-acid analogue of exendin-4, the same lizard-venom peptide exenatide copies.

One page per claimed effect

References

  1. 1
  2. 2
    Meissner WG, et al. Trial of lixisenatide in early Parkinson's disease (LIXIPARK).N Engl J Med, 2024;390:1176–1185156 randomised, 12 months. NCT03439943.
  3. 3

Change log

  • 2026-09-23Initial publication. Grade A on the approval programme and ELIXA; Parkinson's row at B.