Hormones & metabolism GLP-1 receptor agonist
Lixisenatide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
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Key takeaway
Lixisenatide is a short-acting, once-daily GLP-1 receptor agonist derived from the lizard peptide exendin-4, taken before a meal to blunt the after-meal blood sugar spike in type 2 diabetes. It was FDA-approved in 2016 and shown to be cardiovascular-safe in the ELIXA trial in people who had recently had acute coronary syndrome. Its standalone product Adlyxin was discontinued in the U.S. in 2023, though lixisenatide remains available combined with insulin glargine in Soliqua.
At a glance
- What it is
- FDA-approved GLP-1 peptide, formerly sold as Adlyxin for type 2 diabetes
- How it's taken
- Short-acting, once-daily injection taken before a meal
- Availability
- Standalone U.S. product discontinued by its manufacturer in 2023, though still available in a combination with insulin
- Evidence strength
- FDA approved
Summary
Lixisenatide is a once-daily GLP-1 receptor agonist FDA-approved in 2016 for type 2 diabetes. See how it works, its status, and side effects.
What is lixisenatide?
Lixisenatide is a GLP-1 receptor agonist, a peptide that mimics the natural gut hormone GLP-1. Like exenatide, it is based on the lizard peptide exendin-4 with modifications, and it is short-acting, taken once a day before a meal.
It is made by Sanofi and was sold on its own as Adlyxin, and it is also available combined with insulin glargine in a product called Soliqua. It is given as a subcutaneous injection.
How does it work?
Lixisenatide lowers blood sugar by activating the GLP-1 receptor. Through that receptor, it:
- Drives glucose-dependent insulin release, which keeps the risk of hypoglycemia low on its own
- Lowers glucagon
- Markedly slows the rate at which the stomach empties
Because it is short-acting, its strongest effect is blunting the post-meal blood sugar spike rather than providing round-the-clock coverage, which is why it is taken before a meal. In the ELIXA trial, in people who had recently had acute coronary syndrome, lixisenatide was shown to be cardiovascular-safe, one of the first cardiovascular outcome trials for a GLP-1 drug.
Is it FDA-approved?
Editor’s note
Status: Yes. Lixisenatide was approved in the U.S. in 2016 for type 2 diabetes. Sanofi discontinued the standalone Adlyxin product in the U.S. in 2023 for business reasons, though lixisenatide remains available in the combination product Soliqua.
Category: FDA-approved · Primary body area: Hormones & metabolism
Yes. Lixisenatide was approved in the U.S. in 2016 for type 2 diabetes. Sanofi discontinued the standalone Adlyxin product in the U.S. in 2023 for business reasons, though lixisenatide remains available in the combination product Soliqua.
What is lixisenatide prescribed for?
Lixisenatide is prescribed to improve blood sugar control in adults with type 2 diabetes, alongside diet and exercise, with a particular effect on after-meal blood sugar. It is not a treatment for type 1 diabetes. Unlike the long-acting GLP-1 drugs, this short-acting exendin-based agent does not carry a thyroid C-cell tumor boxed warning.
What are the side effects?
The most common side effects are gastrointestinal:
- Nausea
- Vomiting
- Diarrhea
- Headache
- Dizziness
Less common but more serious risks include:
- Pancreatitis, or inflammation of the pancreas
- Severe allergic reactions, including anaphylaxis
- Acute kidney injury, usually from dehydration caused by vomiting or diarrhea
- Low blood sugar, especially when combined with insulin or a sulfonylurea
Sources: FDA prescribing information for Adlyxin (lixisenatide); the ELIXA cardiovascular outcomes trial (Pfeffer et al., The New England Journal of Medicine, 2015, DOI: 10.1056/NEJMoa1509225), indexed on PubMed; and reporting on the 2023 U.S. discontinuation of Adlyxin. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
GLP-1 receptor agonist (PDF)
- [2]
- [3]
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