Lixisenatide dosage in published studies and labels

These are the doses used for Lixisenatide in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.

Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.

Last checked against primary sources:

Studied regimens and sources

Lixisenatide has an FDA-approved human dosage only as part of Soliqua 100/33, a fixed combination with insulin glargine for adults with type 2 diabetes. Soliqua starts at 15 or 30 units once daily (5 or 10 mcg of lixisenatide) and is adjusted weekly up to 60 units (20 mcg of lixisenatide). No standalone lixisenatide (Adlyxin) label is listed on DailyMed as of this review; in the ELIXA and LIXIPARK trials it was given at 10 mcg once daily for 2 weeks, then 20 mcg once daily.

FDA Approved
Dosage evidence summary for Lixisenatide
Human dosing establishedYes
Studied dose range5–20 mcg once daily (lixisenatide component of Soliqua; 10–20 mcg in trials)
RouteSubcutaneous
FrequencyOnce daily
Duration studiedContinuous
TitrationSoliqua: up or down by 2–4 units every week to the fasting glucose goal, maximum 60 units (20 mcg lixisenatide). Trials: 10 mcg for 2 weeks, then 20 mcg.
Evidence levelFDA Approved
Last reviewed2026-11-07

Research-reported dosing

Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.

Research-reported dosing for Lixisenatide, one row per studied regimen
Study / contextPopulationDoseRouteFrequencyDurationOutcome studiedSource
FDA label — Soliqua 100/33 (insulin glargine and lixisenatide), type 2 diabetesFDA-approved label · FDA prescribing information, combination productAdults with type 2 diabetes mellitusStart 15 units (5 mcg lixisenatide) if insulin-naive, on a GLP-1 agonist or on under 30 units of basal insulin; start 30 units (10 mcg) if on 30–60 units of basal insulin; maximum 60 units (20 mcg lixisenatide)SubcutaneousOnce dailyContinuous; titrated weeklyGlycemic controlSOLIQUA 100/33 (insulin glargine and lixisenatide) injection — FDA prescribing information, DailyMed
ELIXA — NCT01147250, phase 3, results postedClinical trial · Phase 3 randomised placebo-controlled trialAdults with type 2 diabetes and a recent acute coronary syndrome (n=6068)10 mcg for 2 weeks, then 20 mcg maintenance (could be lowered to 15 or 10 mcg)Subcutaneous, within 1 hour before breakfastOnce dailyMedian follow-up 25 monthsNoninferior to placebo for major cardiovascular events; not superiorNCT01147250 — Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With Lixisenatide (ELIXA)
LIXIPARK — NCT03439943, phase 2Clinical trial · Phase 2 randomised placebo-controlled trialAdults with early Parkinson's disease, diagnosed under 3 years earlier (n=156)10 mcg a day for 14 days, then 20 mcg a day (could be lowered to 10 mcg)SubcutaneousOnce daily12 months, then a 2-month washoutLess motor disability progression than placebo at 12 months; nausea in 46%NCT03439943 — Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease (LIXIPARK)

Where sources disagree

  • On DailyMed the only current US label with lixisenatide is Soliqua 100/33, where it always comes with insulin glargine (100 units glargine to 33 mcg lixisenatide per mL). Soliqua is dosed in units of the combination, not in micrograms of lixisenatide.
  • The Parkinson's disease result is from one phase 2 trial; it is not an approved use.