For type 2 diabetes mellitus. BLA 125469, held by Eli Lilly And Co. Dulaglutide.
As of Nov 13, 2026, BLA 125469 (Trulicity), held by Eli Lilly And Co, was first approved by FDA on Sep 18, 2014, with 21 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 17, 2022 | Supplement 51Efficacy (new indication or use) · Priority review | Approved | |
| Sep 3, 2020 | Supplement 36Efficacy (new indication or use) · Standard review | Approved | |
| Feb 21, 2020 | Supplement 33Efficacy (new indication or use) · Standard review | Approved | |
| Jan 15, 2019 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | |
| Jun 29, 2018 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Jan 27, 2017 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jan 27, 2017 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Sep 18, 2014 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trulicity0.75MG/0.5ML · injectable;injection | Dulaglutide | Rx |
| Trulicity1.5MG/0.5ML · injectable;injection | Dulaglutide | Rx |
| Trulicity3MG/0.5ML · injectable;injection | Dulaglutide | Rx |
| Trulicity4.5MG/0.5ML · injectable;injection | Dulaglutide | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 12, 2026 | Supplement 65Labeling · Standard review | Approved | |
| May 28, 2025 | Supplement 63Labeling · Standard review | Approved | |
| Nov 1, 2024 | Supplement 61Labeling · Standard review | Approved | |
| Nov 1, 2024 | Supplement 62Labeling | Approved | |
| Nov 17, 2022 | Supplement 51Efficacy (new indication or use) · Priority review | Approved | |
| Jun 10, 2022 | Supplement 46Labeling · Standard review | Approved | |
| Jun 10, 2022 | Supplement 52Labeling | Approved | |
| Sep 30, 2021 | Supplement 44Labeling · Standard review | Approved | |
| Sep 3, 2020 | Supplement 36Efficacy (new indication or use) · Standard review | Approved | |
| Feb 21, 2020 | Supplement 33Efficacy (new indication or use) · Standard review | Approved | |
| Jan 15, 2019 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | |
| Sep 21, 2018 | Supplement 24Labeling · Standard review | Approved | |
| Jun 29, 2018 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Dec 12, 2017 | Supplement 21REMS | Approved | |
| Aug 1, 2017 | Supplement 11Labeling · Standard review | Approved | |
| Aug 1, 2017 | Supplement 13Labeling · Standard review | Approved | |
| Jan 27, 2017 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jan 27, 2017 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Jul 27, 2015 | Supplement 4REMS | Approved | |
| Mar 9, 2015 | Supplement 1Labeling | Approved | |
| Dec 19, 2014 | Supplement 2Labeling · Standard review | Approved | |
| Sep 18, 2014 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
