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.
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 3 | Recruiting | Beijing Dongfang Biotech Co., Ltd. | ||
2024/02/12 | Phase 1 | Recruiting | Christopher D. Verrico | ||
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 |
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 |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| BYETTA | astrazeneca canada inc | 02361817 | Solution - Subcutaneous | 10 MCG / ACT | 5/31/2011 |
| BYDUREON BCISE | astrazeneca canada inc | 02483203 | Suspension (Extended-Release) - Subcutaneous | 2 MG / DOSE | N/A |
| BYDUREON | astrazeneca canada inc | 02448610 | Kit
,
Powder For Suspension, Sustained-Release - Subcutaneous | 2 MG / DOSE | 2/16/2016 |
| BYETTA | astrazeneca canada inc | 02361809 | Solution - Subcutaneous | 5 MCG / ACT | 6/1/2011 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| BYDUREON 2 MG POLVO Y DISOLVENTE PARA SUSPENSION INYECTABLE DE LIBERACION PROLONGADA EN PLUMA PRECARGADA | 111696003 | POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| BYDUREON 2 MG SUSPENSION INYECTABLE DE LIBERACION PROLONGADA EN PLUMA PRECARGADA | 111696005 | SUSPENSION INYECTABLE DE LIBERACION PROLONGADA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| BYETTA 5 MICROGRAMOS SOLUCION INYECTABLE EN PLUMA PRECARGADA | 06362001 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| BYETTA 10 MICROGRAMOS SOLUCION INYECTABLE EN PLUMA PRECARGADA | 06362003 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| BYDUREON 2 MG POLVO Y DISOLVENTE PARA SUSPENSION INYECTABLE DE LIBERACION PROLONGADA | 11696001 | POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Not 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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