Metabolic Research

Lixisenatide

FDA-approved product existsWeight & metabolic
Not yet scored

BioHarmony verdict

Awaiting review

No BioHarmony report yet. It is queued for review; until then, rely on the status and sources below.

What is Lixisenatide?

Lixisenatide is a component of FDA-approved Soliqua 100/33, a fixed-ratio insulin glargine and lixisenatide product for improving glycemic control in adults with type 2 diabetes.

Dosing as published

Approved labelSOLIQUA 100/33 label for the fixed-ratio insulin glargine and lixisenatide product
PopulationAdults covered by the approved SOLIQUA 100/33 indication
DoseThe pen starts at 15 dose-steps for patients naive to basal insulin or using less than 30 units, or 30 dose-steps for patients using 30-60 units of basal insulin. The maximum 60 dose-steps provides 60 units insulin glargine and 20 mcg lixisenatide.
RouteSubcutaneous injection in the abdomen, thigh, or upper arm
FrequencyOnce daily within the hour before the first meal
DurationLong-term use within the approved indication with label-directed titration
PreparationReady-to-use 3 mL prefilled pen containing 100 units/mL insulin glargine and 33 mcg/mL lixisenatide; no reconstitution and do not dilute or mix.
Source: Dosage and Administration sections 2.1-2.5; Dosage Forms and Strengths section 3

More reported protocols

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Members can compare additional reported doses, schedules, and preparation notes.

Trust & sourcing

US approvalFDA-approved product exists
CompoundingAn FDA-approved combination product exists; compounded copies are not FDA approved
Last checked2026-07-13
Next review2026-10-11

Primary sources

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