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Trulicity
Trulicity is a brand of dulaglutide from Eli Lilly, first approved by the FDA on 2014-09-18 under application BLA125469, authorised in the EU as Trulicity, with no open FDA supply records.
Trulicity is Eli Lilly's brand of dulaglutide, approved under BLA125469. Its current FDA label, effective 2026-06-16, 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.
- Active ingredient
- dulaglutide
- Sponsor
- Eli Lilly
- FDA applications
- BLA125469
- First FDA action
- 2014-09-18
- Most recent FDA action
- 2026-03-12
- FDA actions on file
- 22
- EU authorisation
- Trulicity
- Active trials of dulaglutide
- 11
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.
TRULICITY ® is indicated: As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. TRULICITY ® is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated ( 1 ): As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.
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.
| Date | Action | Application |
|---|---|---|
| 2026-03-12 | Labeling | BLA125469 · label |
| 2025-05-28 | Labeling | BLA125469 · label |
| 2024-11-01 | Labeling | BLA125469 · label |
| 2024-11-01 | Labeling | BLA125469 · label |
| 2022-11-17 | Efficacy | BLA125469 · label |
| 2022-06-10 | Labeling | BLA125469 · label |
| 2022-06-10 | Labeling | BLA125469 · label |
| 2021-09-30 | Labeling | BLA125469 · label |
| 2020-09-03 | Efficacy | BLA125469 · label |
| 2020-02-21 | Efficacy | BLA125469 · label |
| 2019-01-15 | Efficacy | BLA125469 · label |
| 2018-09-21 | Labeling | BLA125469 · label |
| 2018-06-29 | Efficacy | BLA125469 · label |
| 2017-12-12 | REMS | BLA125469 · label |
| 2017-08-01 | Labeling | BLA125469 · label |
| 2017-08-01 | Labeling | BLA125469 · label |
| 2017-01-27 | Efficacy | BLA125469 · label |
| 2017-01-27 | Efficacy | BLA125469 · label |
| 2015-07-27 | REMS | BLA125469 · label |
| 2015-03-09 | Labeling | BLA125469 · label |
| 2014-12-19 | Labeling | BLA125469 · label |
| 2014-09-18 | Type 1 - New Molecular Entity original | BLA125469 · label |
For the molecule behind this brand — every trial, every indication under study and the full research record — see dulaglutide.