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.
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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 |
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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
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Clinical
Clinical Trials
383 clinical trials
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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 | 25 | 25 | 69 | 53 | 52 | 218 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 13 | 22 | 44 | 25 | 24 | 124 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 5 | 10 | 10 | 12 | 9 | 44 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 6 | 9 | 3 | 4 | 3 | 21 |
| Healthy volunteers/patients | — | — | — | 7 | — | — | 3 | 5 | 15 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 2 | 3 | — | 5 | 3 | 13 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | 2 | 2 | — | 9 | 1 | 13 |
| Overweight | D050177 | — | E66.3 | 4 | 3 | 2 | 4 | — | 11 |
| Hypoglycemia | D007003 | — | E16.2 | 3 | 4 | 2 | 1 | 3 | 10 |
| Weight loss | D015431 | — | — | 1 | 3 | 3 | 1 | 2 | 9 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | 5 | 1 | — | — | 7 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | 3 | 1 | — | 1 | 4 |
| Syndrome | D013577 | — | — | 1 | 1 | 1 | — | 1 | 3 |
| Craniopharyngioma | D003397 | — | — | 1 | 2 | 1 | — | — | 3 |
| Sexual infantilism | D050035 | — | — | 1 | 1 | 1 | — | 1 | 3 |
| Body weight | D001835 | EFO_0004338 | — | — | 1 | 1 | — | 1 | 3 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | 1 | 1 | — | — | 2 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | 1 | — | 1 | 2 |
| Left ventricular dysfunction | D018487 | — | — | — | — | 2 | — | — | 2 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulinoma | D007340 | — | — | 5 | 1 | — | — | 4 | 9 |
| Congenital hyperinsulinism | D044903 | — | — | 3 | 1 | — | — | 2 | 5 |
| Hyperinsulinism | D006946 | — | E16.1 | 1 | 1 | — | — | 4 | 5 |
| Nesidioblastosis | D046768 | EFO_0007318 | E16.9 | 2 | 1 | — | — | 2 | 4 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 2 | 1 | — | — | — | 3 |
| Ischemic stroke | D000083242 | — | — | — | 3 | — | — | — | 3 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 2 | — | — | 1 | 3 |
| Smoking cessation | D016540 | EFO_0004319 | — | 2 | 2 | — | — | — | 3 |
| Cocaine-related disorders | D019970 | — | F14 | 3 | 1 | — | — | — | 3 |
| Inflammation | D007249 | MP_0001845 | — | 1 | 1 | — | — | 2 | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | — | N19 | 2 | — | — | — | 1 | 3 |
| Glucose metabolism disorders | D044882 | — | — | 1 | — | — | — | 1 | 2 |
| Alcohol drinking | D000428 | EFO_0004329 | — | 1 | — | — | — | — | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 1 | — | — | — | — | 1 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatitis | D010195 | EFO_0000278 | K85 | — | — | — | — | 2 | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 2 | 2 |
| Prader-willi syndrome | D011218 | Orphanet_739 | Q87.11 | — | — | — | — | 2 | 2 |
| 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 |
| Coronary disease | D003327 | — | — | — | — | — | — | 1 | 1 |
| Aortic valve disease | D000082862 | — | — | — | — | — | — | 1 | 1 |
Show 17 more
Epidemiology
Epidemiological information for investigational and approved indications
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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) |
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Bydureon – Alkermes
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Bydureon – AstraZeneca
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Bydureon – Bristol Myers Squibb
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Byetta – Amylin Pharmaceuticals
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Byetta – AstraZeneca
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Byetta – Bristol Myers Squibb
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Exenatide – Eli Lilly
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Estimated US medical usage
Exenatide
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
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Safety
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85,410 adverse events reported
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