Is Lixisenatide legal in the US?
Yes, FDA approved for type 2 diabetes; it is now sold only combined with insulin glargine.
AStrong human evidenceFDA approvedas of 2026-10-26
Approved. Lixisenatide was approved in 2016 as Adlyxin for type 2 diabetes in adults. Sanofi withdrew standalone Adlyxin from the US market effective January 1, 2023 for commercial reasons; the molecule remains available in Soliqua 100/33, a fixed combination with insulin glargine. 13
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Citations
- FDA 2024: Adlyxin (lixisenatide) prescribing information accessdata.fda.gov
- Pfeffer 2015, NEJM: Lixisenatide in patients with type 2 diabetes and acute coronary syndrome (ELIXA) doi.org
- RxLess 2022: Adlyxin will no longer be available in the US rxless.com
Reference information only, not medical advice. Drawn from the Lixisenatide article, fact-checked against the cited sources. No dosing anywhere on this site.