Byetta(exenatide)
Bydureon, Byetta, Exenatide Synthetic (exenatide) is a protein pharmaceutical. Exenatide was first approved as Byetta on 2005-04-28. It is used to treat type 2 diabetes mellitus in the USA. It has been approved in Europe to treat type 2 diabetes mellitus. The pharmaceutical is active against glucagon-like peptide 1 receptor.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Exenatide synthetic (discontinued: Bydureon, Byetta)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Exenatide synthetic
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BYDUREON | AstraZeneca | N-022200 DISCN | 2012-01-27 | 1 products, RLD |
| BYDUREON PEN | AstraZeneca | N-022200 DISCN | 2014-02-28 | 1 products, RLD |
| BYETTA | AstraZeneca | N-021773 DISCN | 2005-04-28 | 2 products, RLD |
| BYDUREON BCISE | AstraZeneca | N-209210 DISCN | 2017-10-20 | 1 products, RLD |
Hide discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bydureon bcise | New Drug Application | 2025-05-28 |
| byetta | New Drug Application | 2025-05-28 |
| exenatide | ANDA | 2024-11-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| type 2 diabetes mellitus | EFO_0001360 | D003924 | E11 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
EXENATIDE SYNTHETIC, BYDUREON, ASTRAZENECA AB | |||
| 2025-01-22 | PED | ||
| 2024-07-22 | NPP | ||
EXENATIDE SYNTHETIC, BYDUREON BCISE, ASTRAZENECA AB | |||
| 2025-01-22 | PED | ||
| 2024-07-22 | NPP | ||
EXENATIDE SYNTHETIC, BYDUREON PEN, ASTRAZENECA AB | |||
| 2025-01-22 | PED | ||
| 2024-07-22 | NPP | ||
EXENATIDE SYNTHETIC, BYETTA, ASTRAZENECA AB | |||
| 2024-11-04 | M-232 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Exenatide Synthetic, Bydureon Bcise, Astrazeneca Ab | |||
| 8895033 | 2030-10-04 | DP | U-2589, U-2590, U-2597, U-2601, U-2602, U-3188, U-3189, U-3190 |
| Exenatide Synthetic, Bydureon, Astrazeneca Ab | |||
| 8361972 | 2028-03-21 | U-2588 | |
| 8501698 | 2027-06-20 | DP | U-2588 |
| 8329648 | 2026-08-18 | U-2588, U-2589, U-2590, U-2593, U-2594, U-2595, U-2596, U-3188, U-3189, U-3190 | |
| 8906851 | 2026-08-18 | U-2588, U-2589, U-2590, U-2593, U-2597, U-3188, U-3189, U-3190 | |
| 9884092 | 2026-08-18 | U-2588, U-2589, U-2590, U-2593, U-2594, U-2595, U-2596, U-2597, U-3188, U-3189, U-3190 | |
| 6515117 | 2025-10-04 | DS, DP | U-2588 |
| 7456254 | 2025-06-30 | DP | U-2588, U-2589, U-2590, U-3188, U-3189, U-3190 |
| 7612176 | 2025-04-13 | DP | U-2588, U-2589, U-2590, U-3188, U-3189, U-3190 |
| 8431685 | 2025-04-13 | DP | U-2588, U-2589, U-2590, U-2597, U-3188, U-3189, U-3190 |
| 8461105 | 2025-04-13 | DP | U-2588, U-2589, U-2590, U-2597, U-3188, U-3189, U-3190 |
HCPCS
No data
Clinical
Clinical Trials
378 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 6 | 9 | 42 | 10 | 13 | 79 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 5 | 10 | 42 | 9 | 7 | 71 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 2 | 2 | 3 | — | 7 |
| Weight loss | D015431 | — | — | — | — | 1 | 1 | 1 | 3 |
| Fatty liver | D005234 | EFO_0003934 | — | — | — | — | 1 | — | 1 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | — | 1 | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | 1 | — | 1 |
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | — | — | 1 | — | 1 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | 1 | — | 1 |
| Brain injuries | D001930 | — | S06.9 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 2 | 1 | — | 1 | 3 |
| Hypoglycemia | D007003 | — | E16.2 | — | 1 | 2 | — | — | 2 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | 1 | — | — | 1 |
| Syndrome | D013577 | — | — | — | — | 1 | — | — | 1 |
| Hyperglycemia | D006943 | — | R73.9 | — | 1 | 1 | — | — | 1 |
| Weight gain | D015430 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Body weight | D001835 | EFO_0004338 | — | — | 2 | — | — | — | 2 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 1 | — | — | — | 1 |
| Infarction | D007238 | EFO_0009463 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | 1 | 4 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | — | — | — | — | 1 | 1 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | — | — | — | 1 | 1 |
| Neuroendocrine carcinoma | D018278 | — | — | — | — | — | — | 1 | 1 |
| Papillary thyroid cancer | D000077273 | — | — | — | — | — | — | 1 | 1 |
| Thyroid diseases | D013959 | — | E00-E07 | — | — | — | — | 1 | 1 |
| Pancreatitis | D010195 | EFO_0000278 | K85 | — | — | — | — | 1 | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | — | 1 | 1 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | — | — | — | 1 | 1 |
| Gestational diabetes | D016640 | — | O24.4 | — | — | — | — | 1 | 1 |
| Pregnancy in diabetics | D011254 | — | O24.91 | — | — | — | — | 1 | 1 |
Show 1 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | Exenatide |
| INN | exenatide |
| Description | EXENATIDE |
| Classification | Protein |
| Drug class | peptides |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(N)=O |
Identifiers
| PDB | — |
| CAS-ID | 141758-74-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL414357 |
| ChEBI ID | — |
| PubChem CID | 16157882 |
| DrugBank | DB01276 |
| UNII ID | 9P1872D4OL (ChemIDplus, GSRS) |
Target
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Bydureon – Alkermes
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Bydureon – AstraZeneca
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Bydureon – Bristol Myers Squibb
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Exenatide – Eli Lilly
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Byetta – Amylin Pharmaceuticals
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Byetta – AstraZeneca
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Byetta – Bristol Myers Squibb
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
Exenatide
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 17,860 documents
View more details
Safety
Black-box Warning
Black-box warning for: Bydureon bcise
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
85,299 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use