Overview
Exenatide is a glucagon-like peptide-1 (GLP-1) analog. It activates the GLP-1 receptor and increases insulin secretion, decreases glucagon secretion, and slows gastric emptying to improve glycemic control. Exenatide was given FDA approval on April 28, 2005. It is available as immediate- and extended-release formulations. Bydureon, the brand name product of extended-release exenatide in an injectable suspension, was discontinued in 2021. Bydureon BCise, an auto-injector extended-release formulation, remains available.
Background
Exenatide is a glucagon-like peptide-1 (GLP-1) analog. It activates the GLP-1 receptor and increases insulin secretion, decreases glucagon secretion, and slows gastric emptying to improve glycemic control. Exenatide was given FDA approval on April 28, 2005. It is available as immediate- and extended-release formulations. Bydureon, the brand name product of extended-release exenatide in an injectable suspension, was discontinued in 2021. Bydureon BCise, an auto-injector extended-release formulation, remains available.
Indication
Exenatide is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. An extended-release formulation is available which is indicated in patients ≥10 years old, while the immediate-acting formulation is approved only for adult patients.
Associated Conditions
- Type 2 Diabetes Mellitus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/02/14 | Phase 3 | Recruiting | Beijing Dongfang Biotech Co., Ltd. | ||
2024/02/12 | Phase 1 | Recruiting | Christopher D. Verrico | ||
2024/02/12 | Phase 3 | Recruiting | Beijing Dongfang Biotech Co., Ltd. | ||
2024/02/08 | Phase 1 | Completed | Beijing Dongfang Biotech Co., Ltd. | ||
2023/01/04 | Phase 1 | Active, not recruiting | |||
2022/12/23 | N/A | Recruiting | |||
2022/11/09 | Phase 2 | Recruiting | |||
2022/08/01 | Phase 4 | Recruiting | Maisa N. Feghali, MD | ||
2022/05/02 | Phase 2 | Recruiting | |||
2021/10/11 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AstraZeneca Pharmaceuticals LP | 0310-6524 | SUBCUTANEOUS | 250 ug in 1 mL | 12/21/2022 | |
| AstraZeneca Pharmaceuticals LP | 0310-6540 | SUBCUTANEOUS | 2 mg in 0.85 mL | 5/4/2023 | |
| Physicians Total Care, Inc. | 54868-5384 | SUBCUTANEOUS | 250 ug in 1 mL | 3/12/2012 | |
| AstraZeneca Pharmaceuticals LP | 0310-6512 | SUBCUTANEOUS | 250 ug in 1 mL | 12/21/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/20/2006 | ||
Authorised | 6/17/2011 | ||
Authorised | 11/20/2006 | ||
Authorised | 6/17/2011 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Exenatide Injection | 国药准字H20244874 | 化学药品 | 注射剂 | 9/10/2024 | |
| Exenatide Injection | 国药准字H20244873 | 化学药品 | 注射剂 | 9/10/2024 | |
| Exenatide Injection | 国药准字H20223542 | 化学药品 | 注射剂 | 7/29/2022 | |
| Exenatide Injection | 国药准字HJ20140821 | 化学药品 | 注射剂 | 6/14/2023 | |
| Exenatide Injection | 国药准字H20223543 | 化学药品 | 注射剂 | 7/29/2022 | |
| Exenatide Injection | 国药准字HJ20140822 | 化学药品 | 注射剂 | 6/14/2023 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||