Lixisenatide

Adlyxin

Grade B: Human evidence, not approved for this use

TL;DR: Lixisenatide (Adlyxin) is a short-acting GLP-1 receptor agonist that was FDA-approved in 2016 for type 2 diabetes and voluntarily withdrawn from the US market by Sanofi effective January 1, 2023, for commercial reasons. The clinical evidence base includes the GetGoal phase 3 trial program, comprising multiple randomized controlled trials evaluating lixisenatide as monotherapy or add-on therapy, which demonstrated HbA1c reductions. The ELIXA cardiovascular outcomes trial in patients with recent acute coronary syndrome showed cardiovascular safety non-inferiority versus placebo but not superiority. The drug achieved grade B because human RCT evidence is substantial, but it is no longer marketed in the US; it remains available in some other markets and as the lixisenatide component of the combination product iGlarLixi (Soliqua 100/33), which remains marketed in the US. Evidence on lixisenatide's weight effects is modest compared to longer-acting agents, consistent with its short-acting postprandial mechanism.

Key Takeaways

Grade B: Human evidence, not approved for this use
Withdrawn: Previously approved as Adlyxin (subcutaneous injection, type 2 diabetes, 2016); voluntarily discontinued in the US as of January 2023. Lixisenatide component remains FDA-approved as part of Soliqua 100/33 (insulin glargine/lixisenatide fixed-ratio combination).
Compounding: Withdrawn from the US market as a standalone product effective January 1, 2023 (Sanofi voluntary discontinuation for commercial reasons). Lixisenatide remains available in the US as a fixed-ratio combination with insulin glargine (Soliqua 100/33). Compounding of a discontinued drug from bulk API by 503A or 503B facilities is not standard practice without a qualifying shortage or clinical necessity pathway.

Lixisenatide chemical structure — Structure via PubChem CID 90472060

Mechanism

Lixisenatide is a short-acting GLP-1 receptor agonist that primarily delays gastric emptying and blunts postprandial glucose excursions, with more modest effects on fasting glucose compared to longer-acting agents in the class.

Evidence

Lixisenatide (Adlyxin) is a short-acting GLP-1 receptor agonist that was FDA-approved in 2016 for type 2 diabetes and voluntarily withdrawn from the US market by Sanofi effective January 1, 2023, for commercial reasons. The clinical evidence base includes the GetGoal phase 3 trial program, comprising multiple randomized controlled trials evaluating lixisenatide as monotherapy or add-on therapy, which demonstrated HbA1c reductions. The ELIXA cardiovascular outcomes trial in patients with recent acute coronary syndrome showed cardiovascular safety non-inferiority versus placebo but not superiority. The drug achieved grade B because human RCT evidence is substantial, but it is no longer marketed in the US; it remains available in some other markets and as the lixisenatide component of the combination product iGlarLixi (Soliqua 100/33), which remains marketed in the US. Evidence on lixisenatide's weight effects is modest compared to longer-acting agents, consistent with its short-acting postprandial mechanism.

Safety and risks

Lixisenatide does not carry a boxed warning for thyroid C-cell tumors; the FDA determined that the clinical exposure margin for C-cell findings in rats was substantially above the human clinical exposure, and no REMS was required, distinguishing lixisenatide from the longer-acting GLP-1 agents in this class. Class risk of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing forms, applies to lixisenatide and is listed in Warnings and Precautions; the drug should not be used in patients with a history of pancreatitis. Serious hypersensitivity reactions including anaphylaxis have been reported in clinical trials and postmarketing use at an incidence rate of approximately 0.2% for lixisenatide versus 0.1% for placebo. Acute kidney injury, in some cases requiring hemodialysis, has been reported in postmarketing reports for GLP-1 receptor agonists including lixisenatide. Common adverse reactions include nausea, vomiting, headache, and diarrhea; gastrointestinal effects are the primary driver of discontinuation.

Interactions

Hypoglycemia risk is increased when combined with insulin or sulfonylureas; dose reduction of concomitant agents may be needed. As a short-acting agent with prominent gastric-emptying delay, lixisenatide has a more pronounced effect on postprandial absorption of oral drugs than longer-acting GLP-1 agents; time-sensitive oral medications should be taken separately.

Federal compounding status

FDA-approved drug as of 2026-06-02.

An FDA-approved drug that should be obtained as the licensed product. It is not a 503A bulk-substance candidate; compounding from bulk is limited under federal rules and generally permitted only during a declared shortage.

Federal status only, from public FDA records. State pharmacy-board rules vary and are not covered here. This is regulatory reporting, not legal advice. All compounds.

Compounding legality

Withdrawn from the US market as a standalone product effective January 1, 2023 (Sanofi voluntary discontinuation for commercial reasons). Lixisenatide remains available in the US as a fixed-ratio combination with insulin glargine (Soliqua 100/33). Compounding of a discontinued drug from bulk API by 503A or 503B facilities is not standard practice without a qualifying shortage or clinical necessity pathway.

Sources

Lixisenatide is Withdrawn. PeptideGrids presents evidence and regulatory status for informational purposes only. We do not sell, supply, source, or help anyone obtain this compound, and we provide no dosing or administration guidance. This is not medical advice; consult a licensed clinician. Full disclaimer.

Last reviewed June 1, 2026 by PeptideGrids editorial team (independently audited).