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Mounjaro

Mounjaro is a brand of tirzepatide from Eli Lilly, first approved by the FDA on 2022-05-13 under application NDA215866, authorised in the EU as Mounjaro, with no open FDA supply records.

Mounjaro is Eli Lilly's brand of tirzepatide, approved under NDA215866. The same molecule is also sold as Zepbound — 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 2026-08-27, covers cardiovascular disease, 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.

Mounjaro and Zepbound 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: Mounjaro vs Zepbound.

Active ingredient

tirzepatide

Sponsor

Eli Lilly

FDA applications

NDA215866

First FDA action

2022-05-13

Most recent FDA action

2026-08-27

FDA actions on file

42

EU authorisation

Mounjaro

Active trials of tirzepatide

99

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 tirzepatide.