FDA approved Adlyxin in 2016; the lixisenatide injection is no longer sold in the US

Adlyxin (lixisenatide), a glucagon-like peptide-1 (GLP-1) receptor agonist from Sanofi, gained FDA approval in 2016. It was indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ^[1]. The drug is no longer available in the United States: Sanofi's product site states that it will no longer be available in the US, and a posting on the FDA's Drug Shortages tracker indicates the product has been discontinued ^[1].

At approval, Adlyxin entered a class that already held several other GLP-1 products for type 2 diabetes. The alternatives named in the same record include Bydureon Bcise (exenatide extended-release for subcutaneous injection), Byetta (exenatide for subcutaneous injection), Ozempic (semaglutide for subcutaneous injection), Rybelsus (semaglutide tablets), Trulicity (dulaglutide for subcutaneous injection) and Victoza (liraglutide for subcutaneous injection) ^[1].

The record around the discontinuation is thin. Neither Sanofi's statement nor the FDA tracker posting gives a reason for the decision, and no date for when US supplies ran out has been disclosed ^[1]. How many US patients were taking Adlyxin, and how its use compared with other drugs in the class, has not been reported. Whether lixisenatide remains on the market outside the United States is not addressed.

Why it matters for patients

The practical consequence is that Adlyxin is no longer an option in the US for adults with type 2 diabetes ^[1]. Someone holding a prescription for it cannot expect to keep filling it, and the discontinuation notice does not include instructions for patients or a recommended substitute ^[1].

The class it belonged to is still active in the US. The same record lists six GLP-1 therapies indicated for diabetes treatment that remain available, spanning injectables and one oral tablet ^[1]. Which of those fits a given patient is a clinical decision, and the notice itself does not offer guidance on switching.

Availability changes in the US tend to surface in two places — the manufacturer's own product page and the FDA's Drug Shortages tracker — and that is where the Adlyxin discontinuation appears ^[1]. Patients or caregivers who want to confirm whether a product is still shipping can check the same tracker, since it is the agency's public listing of products in short supply or discontinued ^[1].

What happens next

As of February 6, 2023, the date the FDA Drug Shortages entry was accessed, the Sanofi statement and the tracker posting were the public record on Adlyxin's US availability ^[1]. No plan to return the product to the US market has been announced, and no explanation of the discontinuation has been reported ^[1]. Nothing in that record addresses what happens to lixisenatide outside the US.