{"id":"lixisenatide","name":"Lixisenatide","aliases":["Adlyxin","Lyxumia","AVE0010","Soliqua (with insulin glargine)"],"url":"https://lyoresearch.com/compounds/lixisenatide","class":{"id":"glp-1-agonists","name":"GLP-1 and incretin agonists","url":"https://lyoresearch.com/classes/glp-1-agonists"},"summary":"Lixisenatide 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 It is prescription-only; the standalone product has been withdrawn in some markets.","overall_grade":"A","overall_grade_meaning":"established in humans","human_trials":"GetGoal programme; ELIXA (n=6,068); LIXIPARK (n=156)","regulatory_status":"Approved (Rx)","molecule":{"formula":"C215H347N61O65S","molecular_weight":"4858","cas":"320367-13-3","pubchem_cid":90472060,"note":null},"pharmacokinetics":{"basis":"label","route":"Subcutaneous injection, once daily before the first meal","half_life":"About 3 hours","licensed_regimen":"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","product":"Soliqua 100/33 (with insulin glargine)","source":{"title":"Soliqua 100/33 prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bba538b-cf7c-4310-ae8f-cb711ed21bcc"}},"outcomes":[{"outcome":"Blood glucose (HbA1c)","grade":"A","grade_meaning":"established in humans","effect_size":"moderate","adverse":false,"human_studies":"GetGoal programme (10+ RCTs)","evidence":"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.","references":[{"citation":"Soliqua 100/33 prescribing information (insulin glargine and lixisenatide).","where":"DailyMed","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bba538b-cf7c-4310-ae8f-cb711ed21bcc"}]},{"outcome":"Major cardiovascular events","grade":"A","grade_meaning":"established in humans","effect_size":"not measurable","adverse":false,"human_studies":"1 large RCT (ELIXA, n=6,068)","evidence":"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.","references":[{"citation":"Pfeffer MA, et al. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome (ELIXA).","where":"N Engl J Med, 2015;373:2247–2257","url":"https://pubmed.ncbi.nlm.nih.gov/?term=Pfeffer+lixisenatide+acute+coronary+syndrome+ELIXA+2015"}],"verbatim":{"text":"A primary end-point event occurred in 406 patients (13.4%) in the lixisenatide group and in 399 (13.2%) in the placebo group (hazard ratio, 1.02; 95% confidence interval [CI], 0.89 to 1.17), which showed the noninferiority of lixisenatide to placebo (P<0.001) but did not show superiority (P=0.81).","citation":"Pfeffer MA, et al. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome (ELIXA).","url":"https://pubmed.ncbi.nlm.nih.gov/?term=Pfeffer+lixisenatide+acute+coronary+syndrome+ELIXA+2015"}},{"outcome":"Motor progression in early Parkinson's disease","grade":"B","grade_meaning":"probable, not settled","effect_size":"small","adverse":false,"human_studies":"1 phase 2 RCT (n=156, 12 mo)","evidence":"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.","references":[{"citation":"Meissner WG, et al. Trial of lixisenatide in early Parkinson's disease (LIXIPARK).","where":"N Engl J Med, 2024;390:1176–1185","url":"https://pubmed.ncbi.nlm.nih.gov/38598572/"}],"verbatim":{"text":"At 12 months, scores on the MDS-UPDRS part III had changed by -0.04 points (indicating improvement) in the lixisenatide group and 3.04 points (indicating worsening disability) in the placebo group (difference, 3.08; 95% confidence interval, 0.86 to 5.30; P = 0.007).","citation":"Meissner WG, et al. Trial of lixisenatide in early Parkinson's disease (LIXIPARK).","url":"https://pubmed.ncbi.nlm.nih.gov/38598572/"}},{"outcome":"GI side effects","grade":"A","grade_meaning":"established in humans","effect_size":"moderate","adverse":true,"human_studies":"All trials","evidence":"The class profile; in the Parkinson's trial, where participants were not diabetic, nausea affected almost half.","references":[{"citation":"Meissner WG, et al. Trial of lixisenatide in early Parkinson's disease (LIXIPARK).","where":"N Engl J Med, 2024;390:1176–1185","url":"https://pubmed.ncbi.nlm.nih.gov/38598572/"}],"verbatim":{"text":"Nausea occurred in 46% of participants receiving lixisenatide, and vomiting occurred in 13%.","citation":"Meissner WG, et al. Trial of lixisenatide in early Parkinson's disease (LIXIPARK).","url":"https://pubmed.ncbi.nlm.nih.gov/38598572/"}}],"regions":[{"region":"European Union","status":"Approved, prescription-only","note":"Lyxumia authorised 2013; Suliqua (with insulin glargine) authorised 2017. Check availability of the standalone product, which Sanofi has discontinued in several markets."},{"region":"United States","status":"Approved, prescription-only","note":"Adlyxin approved 2016; only the Soliqua combination is currently listed on DailyMed, the standalone product having been discontinued."},{"region":"United Kingdom","status":"Licensed, prescription-only","note":"Lyxumia and Suliqua licensed by the MHRA."},{"region":"Australia","status":"Registered, Schedule 4","note":"Registered as Lyxumia / Soliqua."},{"region":"Canada","status":"Authorised, prescription-only","note":"Adlyxine and Soliqua."},{"region":"Sport (WADA)","status":"Not prohibited","note":"GLP-1 receptor agonists are not on the Prohibited List."}],"faq":[{"q":"Does lixisenatide treat Parkinson's disease?","a":"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."},{"q":"Why is lixisenatide less used than semaglutide?","a":"It is short-acting and once-daily, produces less weight loss, and its heart trial was neutral where semaglutide's was positive."},{"q":"Is lixisenatide a peptide?","a":"Yes — a 44-amino-acid analogue of exendin-4, the same lizard-venom peptide exenatide copies."}],"references":[{"cite":"Pfeffer MA, et al. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome (ELIXA).","where":"N Engl J Med, 2015;373:2247–2257","url":"https://pubmed.ncbi.nlm.nih.gov/?term=Pfeffer+lixisenatide+acute+coronary+syndrome+ELIXA+2015","note":"6,068 randomised; HR 1.02."},{"cite":"Meissner WG, et al. Trial of lixisenatide in early Parkinson's disease (LIXIPARK).","where":"N Engl J Med, 2024;390:1176–1185","url":"https://pubmed.ncbi.nlm.nih.gov/38598572/","note":"156 randomised, 12 months. NCT03439943."},{"cite":"Soliqua 100/33 prescribing information (insulin glargine and lixisenatide).","where":"DailyMed","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bba538b-cf7c-4310-ae8f-cb711ed21bcc","note":"Regulatory status and pharmacokinetics."}],"last_reviewed":"2026-09-23","literature_searched_to":"2026-09-23","changelog":[{"date":"2026-09-23","note":"Initial publication. Grade A on the approval programme and ELIXA; Parkinson's row at B."}],"license":"CC BY 4.0 — cite as “LYO Research” with a link.","methodology":"https://lyoresearch.com/methodology"}