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Xultophy

Xultophy is a brand of liraglutide from Novo Nordisk, first approved by the FDA on 2016-11-21 under application BLA208583, authorised in the EU as Xultophy, with no open FDA supply records.

Xultophy is Novo Nordisk's brand of liraglutide, approved under BLA208583. The same molecule is also sold as Saxenda, Victoza — 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 2025-10-14, covers type 2 diabetes. Nothing under this name is currently on the FDA shortage list. It is also authorised in the EU, which does not always follow the US indication wording.

Xultophy and Saxenda, Victoza 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: Xultophy vs Saxenda · Xultophy vs Victoza.

Active ingredient

liraglutide

Sponsor

Novo Nordisk

FDA applications

BLA208583

First FDA action

2016-11-21

Most recent FDA action

2025-10-14

FDA actions on file

16

EU authorisation

Xultophy

Active trials of liraglutide

17

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 liraglutide.