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Soliqua

Soliqua is a brand of lixisenatide from Sanofi, first approved by the FDA on 2016-11-21 under application BLA208673, not separately authorised in the European Union under this name, with no open FDA supply records.

Soliqua is Sanofi's brand of lixisenatide, approved under BLA208673. The same molecule is also sold as Adlyxin — 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. Its current FDA label, effective 2026-03-18, covers type 2 diabetes. Nothing under this name is currently on the FDA shortage list.

Soliqua and Adlyxin 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: Soliqua vs Adlyxin.

Active ingredient

lixisenatide

Sponsor

Sanofi

FDA applications

BLA208673

First FDA action

2016-11-21

Most recent FDA action

2026-03-12

FDA actions on file

12

EU authorisation

Not under this name

Active trials of lixisenatide

4

Approved indications

Quoted from the current FDA label for each application. This is what the drug is approved to treat in the US — separate from the conditions it is being studied in.

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.