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Adlyxin

Adlyxin is a brand of lixisenatide from Sanofi, first approved by the FDA on 2016-07-27 under application BLA208471, not separately authorised in the European Union under this name, with no open FDA supply records.

Adlyxin is Sanofi's brand of lixisenatide, approved under BLA208471. The same molecule is also sold as Soliqua — a separate application with its own approved uses and its own supply record, which is why the two are tracked apart here rather than merged. Nothing under this name is currently on the FDA shortage list.

Adlyxin and Soliqua are the same molecule. They are marketed under separate FDA applications with different approved indications, so they are distinct products on the regulatory record even though the active ingredient is identical. Compare the applications below. Side by side: Adlyxin vs Soliqua.

Active ingredient

lixisenatide

Sponsor

Sanofi

FDA applications

BLA208471

First FDA action

2016-07-27

Most recent FDA action

2026-03-12

FDA actions on file

7

EU authorisation

Not under this name

Active trials of lixisenatide

4

FDA record

Every approved submission filed under this brand, newest first, from Drugs@FDA: original approval, efficacy supplements, labeling changes and manufacturing updates. New safety language usually arrives in a labeling supplement.

For the molecule behind this brand — every trial, every indication under study and the full research record — see lixisenatide.