Overview
Dulaglutide, marketed by Eli Lilly as Trulicity, is a once-weekly subcutaneous glucagon-like peptide-1 (GLP-1) receptor agonist designed using recombinant DNA technology; it has been approved as an adjunct therapy to diet and exercise in the management of 2 diabetes (T2DM). Dulaglutide was initially approved by the FDA in 2014, and in February 2020 was approved for use in patients with T2DM and multiple cardiovascular risk factors for the prevention of cardiovascular events. It is the first T2DM drug approved to reduce major adverse cardiovascular events (MACE) risk in primary and secondary prevention populations.
Indication
Dulaglutide is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients ≥10 years of age with type 2 diabetes mellitus. It is also indicated 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.
Associated Conditions
- Major Adverse Cardiovascular Events
- Type 2 Diabetes Mellitus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/31 | N/A | Active, not recruiting | |||
2025/07/28 | N/A | Active, not recruiting | |||
2025/03/30 | Phase 2 | Recruiting | Jiangsu Hansoh Pharmaceutical Co., Ltd. | ||
2025/02/28 | Phase 4 | Not yet recruiting | Fundación para la Investigación del Hospital Clínico de Valencia | ||
2025/01/17 | N/A | Active, not recruiting | |||
2024/12/18 | Phase 3 | Recruiting | |||
2024/09/25 | Not Applicable | Active, not recruiting | Attikon Hospital | ||
2024/08/01 | Not Applicable | Recruiting | |||
2024/03/26 | Not Applicable | Recruiting | First Affiliated Hospital of Zhejiang University | ||
2024/03/22 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Eli Lilly and Company | 0002-3182 | SUBCUTANEOUS | 4.5 mg in 0.5 mL | 1/19/2021 | |
| A-S Medication Solutions | 50090-3484 | SUBCUTANEOUS | 0.75 mg in 0.5 mL | 1/19/2021 | |
| A-S Medication Solutions | 50090-6456 | SUBCUTANEOUS | 1.5 mg in 0.5 mL | 1/19/2021 | |
| Eli Lilly and Company | 0002-2236 | SUBCUTANEOUS | 3.0 mg in 0.5 mL | 1/19/2021 | |
| A-S Medication Solutions | 50090-6453 | SUBCUTANEOUS | 0.75 mg in 0.5 mL | 1/19/2021 | |
| A-S Medication Solutions | 50090-6571 | SUBCUTANEOUS | 3.0 mg in 0.5 mL | 1/19/2021 | |
| A-S Medication Solutions | 50090-3483 | SUBCUTANEOUS | 1.5 mg in 0.5 mL | 1/19/2021 | |
| Eli Lilly and Company | 0002-1434 | SUBCUTANEOUS | 1.5 mg in 0.5 mL | 1/19/2021 | |
| Eli Lilly and Company | 0002-1433 | SUBCUTANEOUS | 0.75 mg in 0.5 mL | 1/19/2021 | |
| A-S Medication Solutions | 50090-5467 | SUBCUTANEOUS | 3.0 mg in 0.5 mL | 1/19/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/21/2014 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TRULICITY INJECTION 0.75MG/0.5ML | SIN14968P | INJECTION, SOLUTION | 0.75mg/0.5ml | 3/18/2016 | |
| TRULICITY INJECTION 1.5MG/0.5ML | SIN14967P | INJECTION, SOLUTION | 1.5mg/0.5ml | 3/18/2016 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TRULICITY dulaglutide (rch) 1.5 mg/0.5 mL solution for injection prefilled pen | 217965 | Medicine | A | 1/19/2015 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| TRULICITY | eli lilly canada inc | 02530171 | Solution - Subcutaneous | 4.5 MG / 0.5 ML | N/A |
| TRULICITY | eli lilly canada inc | 02530163 | Solution - Subcutaneous | 3 MG / 0.5 ML | N/A |
| TRULICITY | eli lilly canada inc | 02448572 | Solution - Subcutaneous | 0.75 MG / 0.5 ML | N/A |
| TRULICITY | eli lilly canada inc | 02448599 | Solution - Subcutaneous | 0.75 MG / 0.5 ML | 1/8/2016 |
| TRULICITY | eli lilly canada inc | 02448580 | Solution - Subcutaneous | 1.5 MG / 0.5 ML | N/A |
| TRULICITY | eli lilly canada inc | 02448602 | Solution - Subcutaneous | 1.5 MG / 0.5 ML | 11/24/2015 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| TRULICITY 1,5 mg SOLUCION INYECTABLE EN PLUMA PRECARGADA | 114956007 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| TRULICITY 4,5 mg SOLUCION INYECTABLE EN PLUMA PRECARGADA | 1140956015 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| TRULICITY 3 mg SOLUCION INYECTABLE EN PLUMA PRECARGADA | 1140956012 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| TRULICITY 0,75 mg SOLUCION INYECTABLE EN PLUMA PRECARGADA | 114956002 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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