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dulaglutide
FDA-approved since 2014 and marketed in the US as Trulicity, authorised in the EU as Trulicity, with no open FDA shortage or discontinuation records. 11 active trials, the next due to complete 2026-10-01.
GLP-1 agonist, SC, from Eli Lilly. Every figure below is taken directly from ClinicalTrials.gov, Drugs@FDA, the FDA Drug Shortage Database, the EMA register or Europe PMC, and re-checked every four hours.
- Status
- marketed
- Target
- GLP-1
- Route
- SC
- Sponsor
- Eli Lilly
- Brand names
- Trulicity
- First FDA approval
- 2014-09-18
- EU authorisation
- Trulicity (2018)
- Active trials
- 11 (5 in phase 3)
- Participants enrolled
- 2,694
- Trials with a reporting date
- 4
- Approved FDA submissions
- 22
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.
When these trials report
Next 4 of 4 active trials by estimated primary completion.
| Est. completion | Trial | Sponsor | Phase | Participants |
|---|---|---|---|---|
| 2026-10-01 | A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin NCT06257966 · HbA1c | Beijing Dongfang Biotech Co., Ltd. | P3 | 600 |
| 2027-03-30 | A Phase 3 Study of HS-20094 in Patients With T2DM NCT07156539 · Change in HbA1c | Jiangsu Hansoh Pharmaceutical Co., Ltd. | P3 | 546 |
| 2027-04 | Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease NCT07537088 · Urine Albumin-to-Creatinine Ratio（UACR） | First Affiliated Hospital of Wannan Medical College | P4 | 468 |
| 2028-12-31 | GLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac Surgery NCT06324461 · Proportion of patients with MINS | The University of Hong Kong | P4 | 372 |
Regulatory history
| Date | Action | Brands | Application |
|---|---|---|---|
| 2026-03-12 | Labeling | TRULICITY | BLA125469 · label |
| 2025-05-28 | Labeling | TRULICITY | BLA125469 · label |
| 2024-11-01 | Labeling | TRULICITY | BLA125469 · label |
| 2024-11-01 | Labeling | TRULICITY | BLA125469 · label |
| 2022-11-17 | Efficacy | TRULICITY | BLA125469 · label |
| 2022-06-10 | Labeling | TRULICITY | BLA125469 · label |
| 2022-06-10 | Labeling | TRULICITY | BLA125469 · label |
| 2021-09-30 | Labeling | TRULICITY | BLA125469 · label |
| 2020-09-03 | Efficacy | TRULICITY | BLA125469 · label |
| 2020-02-21 | Efficacy | TRULICITY | BLA125469 · label |
| 2019-01-15 | Efficacy | TRULICITY | BLA125469 · label |
| 2018-09-21 | Labeling | TRULICITY | BLA125469 · label |
| 2018-06-29 | Efficacy | TRULICITY | BLA125469 · label |
| 2017-12-12 | REMS | TRULICITY | BLA125469 · label |
| 2017-08-01 | Labeling | TRULICITY | BLA125469 · label |
| 2017-08-01 | Labeling | TRULICITY | BLA125469 · label |
| 2017-01-27 | Efficacy | TRULICITY | BLA125469 · label |
| 2017-01-27 | Efficacy | TRULICITY | BLA125469 · label |
| 2015-07-27 | REMS | TRULICITY | BLA125469 · label |
| 2015-03-09 | Labeling | TRULICITY | BLA125469 · label |
| 2014-12-19 | Labeling | TRULICITY | BLA125469 · label |
| 2014-09-18 | Type 1 - New Molecular Entity original | TRULICITY | BLA125469 · label |
Indications under study
Abnormal Glucose Tolerance; CKD - Chronic Kidney Disease; Cystic Fibrosis; Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Endothelial Dysfunction; Intracranial Atherosclerosis; Myocardial Injury; Pancreatic Insufficiency; Stroke, Ischemic; T2DM (Type 2 Diabetes Mellitus); Type 2 Diabetes; Type2 Diabetes Mellitus.