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.
| Human dosing established | Yes |
|---|---|
| Studied dose range | 5–20 mcg once daily (lixisenatide component of Soliqua; 10–20 mcg in trials) |
| Route | Subcutaneous |
| Frequency | Once daily |
| Duration studied | Continuous |
| Titration | Soliqua: 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 level | FDA Approved |
| Last reviewed | 2026-11-07 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| FDA label — Soliqua 100/33 (insulin glargine and lixisenatide), type 2 diabetesFDA-approved label · FDA prescribing information, combination product | Adults with type 2 diabetes mellitus | Start 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) | Subcutaneous | Once daily | Continuous; titrated weekly | Glycemic control | SOLIQUA 100/33 (insulin glargine and lixisenatide) injection — FDA prescribing information, DailyMed |
| ELIXA — NCT01147250, phase 3, results postedClinical trial · Phase 3 randomised placebo-controlled trial | Adults 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 breakfast | Once daily | Median follow-up 25 months | Noninferior to placebo for major cardiovascular events; not superior | NCT01147250 — 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 trial | Adults 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) | Subcutaneous | Once daily | 12 months, then a 2-month washout | Less 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.