Lixisenatide

Human evidence can mean a controlled clinical study, an observational study, a safety or exposure report, or evidence from a particular finished formulation. Those are different kinds of information.

Human evidence in specific contexts. Human studies are available in defined contexts, but the evidence remains product-, population-, route-, or outcome-specific.

Preclinical means research in cells, tissues, or animals rather than in people. It can help researchers form a hypothesis, but it cannot establish a human benefit or a complete human safety profile.

Nonclinical evidence informed lixisenatide development, but the current public interpretation should remain anchored to the studied combination product and human label evidence.[1]

Preclinical findings do not establish outcomes in people.

Risk information may describe the compound, a finished product, a route, a population, or product-quality concerns. The cited material does not replace a current product label or an individual professional assessment.

This section is about the United States only. Status applies to a product, formulation, route, population, and use—not to a name in the abstract. A status shown here is not a recommendation or a statement about another country.

• Source/status dateMar 20, 2026

  FDA-approved medicine

  Lixisenatide is an active ingredient in FDA-approved Soliqua 100/33. This assertion is limited to that labeled combination product and does not claim that every stand-alone lixisenatide product is currently marketed.

  Specific product form or route is not separately published in this status record.

  Open source context

The date above is the date attached to the published status record or source context. It is not necessarily the original approval date.

These prompts help organise a conversation with a qualified professional. They do not create a treatment recommendation, dose, or protocol.

• EvidenceWhich human evidence applies to the exact product, form, route, and use being discussed?
• What remains uncertainWhat is known, and what remains uncertain for this specific context?
• RisksWhich important warnings, common effects, and product-quality concerns should be discussed?
• U.S. statusWhat does the U.S. status cover, and what does it not cover?

Related means that the profiles share a topic, pathway, product context, or research question. It does not mean that they are equivalent.

• PramlintideBoth affect post-meal glucose pathways in clinician-directed diabetes care.

PeptideGrid review date: Jul 22, 2026. Sources support the specific sections that cite them. Publication does not imply endorsement, equivalence, or individual suitability.

1. 1

   SOLIQUA 100/33 prescribing information

   DailyMed. SOLIQUA 100/33 (insulin glargine and lixisenatide) prescribing information. Revised March 2026.

   National Library of Medicine / Sanofi · Published Mar 20, 2026 · Accessed Jul 22, 2026 · Prescribing information

   Open source