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exenatide
FDA-approved since 2005 and marketed in the US as Bydureon, Byetta, Exenatide, authorised in the EU as Bydureon, Byetta, with no open FDA shortage or discontinuation records. 5 active trials.
GLP-1 agonist, SC, from AstraZeneca. 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
- AstraZeneca
- First FDA approval
- 2005-04-28
- EU authorisation
- Bydureon (2017), Byetta (2018)
- Active trials
- 5 (3 in phase 3)
- Participants enrolled
- 487
- Trials with a reporting date
- 0
- Approved FDA submissions
- 87
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.
Exenatide injection is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Exenatide injection is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 , 14 ) Limitations of Use Co-administration with other exenatide-containing products is not recommended. ( 1 ) Limitations of Use Exenatide injection contains exenatide. Co-administration with other exenatide-containing products is not recommended.
BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use • BYETTA contains exenatide. Coadministration with other exenatide-containing products is not recommended. BYETTA (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 , 14 ) Limitations of Use • Coadministration with other exenatide-containing products is not recommended ( 1 ).
Regulatory history
| Date | Action | Brands | Application |
|---|---|---|---|
| 2025-09-02 | Labeling | BYETTA | NDA021773 · label |
| 2025-05-28 | Labeling | BYDUREON, BYDUREON PEN | NDA022200 · label |
| 2025-05-28 | Labeling | BYDUREON BCISE | NDA209210 · label |
| 2025-05-28 | Labeling | BYETTA | NDA021773 · label |
| 2024-11-19 | Generic approval (ANDA) original | EXENATIDE SYNTHETIC | ANDA206697 |
| 2024-11-01 | Labeling | BYDUREON, BYDUREON PEN | NDA022200 · label |
| 2024-11-01 | Labeling | BYDUREON BCISE | NDA209210 · label |
| 2024-11-01 | Labeling | BYETTA | NDA021773 · label |
| 2024-03-06 | Labeling | BYDUREON BCISE | NDA209210 · label |
| 2022-12-21 | Labeling | BYDUREON, BYDUREON PEN | NDA022200 · label |
| 2022-12-21 | Labeling | BYDUREON BCISE | NDA209210 · label |
| 2022-12-21 | Labeling | BYETTA | NDA021773 · label |
| 2022-07-26 | Labeling | BYDUREON, BYDUREON PEN | NDA022200 · label |
| 2022-07-26 | Labeling | BYDUREON BCISE | NDA209210 · label |
| 2022-06-10 | Labeling | BYDUREON, BYDUREON PEN | NDA022200 · label |
| 2022-06-10 | Labeling | BYDUREON BCISE | NDA209210 · label |
| 2022-06-10 | Labeling | BYETTA | NDA021773 · label |
| 2022-06-10 | Labeling | BYETTA | NDA021773 · label |
| 2021-11-04 | Efficacy | BYETTA | NDA021773 · label |
| 2021-07-22 | Efficacy | BYDUREON, BYDUREON PEN | NDA022200 · label |
| 2021-07-22 | Efficacy | BYDUREON BCISE | NDA209210 · label |
| 2021-06-17 | Labeling | BYETTA | NDA021773 · label |
| 2020-12-02 | Labeling | BYDUREON BCISE | NDA209210 · label |
| 2020-02-28 | Labeling | BYDUREON, BYDUREON PEN | NDA022200 · label |
| 2020-02-28 | Labeling | BYDUREON BCISE | NDA209210 · label |
Indications under study
Childhood Obesity; Gestational Diabetes; Multiple Sclerosis; Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus.