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Drug ReportsExenatide
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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Target
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Financial
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FDA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
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
BYDUREONAstraZenecaN-022200 DISCN2012-01-27
1 products, RLD
BYDUREON PENAstraZenecaN-022200 DISCN2014-02-28
1 products, RLD
BYETTAAstraZenecaN-021773 DISCN2005-04-28
2 products, RLD
BYDUREON BCISEAstraZenecaN-209210 DISCN2017-10-20
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
bydureon bciseNew Drug Application2025-05-28
byettaNew Drug Application2025-05-28
exenatideANDA2024-11-22
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration
Code
EXENATIDE SYNTHETIC, BYDUREON, ASTRAZENECA AB
2025-01-22PED
2024-07-22NPP
EXENATIDE SYNTHETIC, BYDUREON BCISE, ASTRAZENECA AB
2025-01-22PED
2024-07-22NPP
EXENATIDE SYNTHETIC, BYDUREON PEN, ASTRAZENECA AB
2025-01-22PED
2024-07-22NPP
EXENATIDE SYNTHETIC, BYETTA, ASTRAZENECA AB
2024-11-04M-232
Patent Expiration
Patent
Expires
Flag
FDA Information
Exenatide Synthetic, Bydureon Bcise, Astrazeneca Ab
88950332030-10-04DPU-2589, U-2590, U-2597, U-2601, U-2602, U-3188, U-3189, U-3190
Exenatide Synthetic, Bydureon, Astrazeneca Ab
83619722028-03-21U-2588
85016982027-06-20DPU-2588
83296482026-08-18U-2588, U-2589, U-2590, U-2593, U-2594, U-2595, U-2596, U-3188, U-3189, U-3190
89068512026-08-18U-2588, U-2589, U-2590, U-2593, U-2597, U-3188, U-3189, U-3190
98840922026-08-18U-2588, U-2589, U-2590, U-2593, U-2594, U-2595, U-2596, U-2597, U-3188, U-3189, U-3190
65151172025-10-04DS, DPU-2588
74562542025-06-30DPU-2588, U-2589, U-2590, U-3188, U-3189, U-3190
76121762025-04-13DPU-2588, U-2589, U-2590, U-3188, U-3189, U-3190
84316852025-04-13DPU-2588, U-2589, U-2590, U-2597, U-3188, U-3189, U-3190
84611052025-04-13DPU-2588, U-2589, U-2590, U-2597, U-3188, U-3189, U-3190
ATC Codes
A: Alimentary tract and metabolism drugs
— A10: Drugs used in diabetes
— A10B: Blood glucose lowering drugs, excl. insulins
— A10BJ: Glucagon-like peptide-1 (glp-1) analogues
— A10BJ01: Exenatide
HCPCS
No data
Clinical
Clinical Trials
378 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 mellitusD003924EFO_0001360E112524695151214
Diabetes mellitusD003920EFO_0000400E08-E132229674035186
ObesityD009765EFO_0001073E66.9491010738
Type 1 diabetes mellitusD003922EFO_0001359E106934321
Healthy volunteers/patients———7——3515
OverweightD050177—E66.33317114
SyndromeD013577——121339
Glucose intoleranceD018149HP_0000833R73.03———8—8
Fatty liverD005234EFO_0003934——324—7
Polycystic ovary syndromeD011085EFO_0000660E28.2—224—7
Show 43 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypoglycemiaD007003—E16.2433—310
Parkinson diseaseD010300EFO_0002508G20151——7
Morbid obesityD009767EFO_0001074——31—14
Pediatric obesityD063766———11——2
CraniopharyngiomaD003397———11——2
AdamantinomaD050398———11——2
Cognitive dysfunctionD060825—G31.84—11——2
Left ventricular dysfunctionD018487————2——2
Cognition disordersD003072————1——1
St elevation myocardial infarctionD000072657————1——1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InsulinomaD007340——51——38
Congenital hyperinsulinismD044903——31——36
NesidioblastosisD046768EFO_0007318E16.931——36
HyperinsulinismD006946—E16.111——45
StrokeD020521EFO_0000712I63.9—3——14
AlcoholismD000437EFO_0003829F10.121———3
Smoking cessationD016540EFO_0004319—22———3
Cocaine-related disordersD019970—F1431———3
Ischemic strokeD000083242———2———2
Bariatric surgeryD050110——11——12
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437—N192———13
Alcoholic intoxicationD000435——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PancreatitisD010195EFO_0000278K85————22
Pancreatic neoplasmsD010190EFO_0003860C25————22
Prader-willi syndromeD011218Orphanet_739Q87.11————22
Congenital abnormalitiesD000013EFO_0003915Q89.9————22
CarcinomaD002277—C80.0————11
Thyroid neoplasmsD013964EFO_0003841—————11
Neuroendocrine carcinomaD018278——————11
Papillary thyroid cancerD000077273——————11
Thyroid diseasesD013959—E00-E07————11
Coronary diseaseD003327——————11
Show 20 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameExenatide
INNexenatide
Description
EXENATIDE
Classification
Protein
Drug classpeptides
Image (chem structure or protein)Loading
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-ID141758-74-9
RxCUI—
ChEMBL IDCHEMBL414357
ChEBI ID—
PubChem CID16157882
DrugBankDB01276
UNII ID9P1872D4OL (ChemIDplus, GSRS)
Target
Agency Approved
GLP1R
GLP1R
Organism
Homo sapiens
Gene name
GLP1R
Gene synonyms
NCBI Gene ID
Protein name
glucagon-like peptide 1 receptor
Protein synonyms
GLP-1 receptor, GLP1 receptor, seven transmembrane helix receptor
Uniprot ID
Mouse ortholog
Glp1r (14652)
glucagon-like peptide 1 receptor (Q1JQR8)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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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Tabular view
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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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 18,004 documents
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Safety
Black-box Warning
Black-box warning for: Bydureon bcise
Adverse Events
Top Adverse Reactions
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85,299 adverse events reported
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