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Byetta(exenatide)
Bydureon, Byetta (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 diseasesD009750
endocrine system diseasesD004700
Trade Name
FDA
EMA
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
BYETTAAstraZenecaN-021773 RX2005-04-28
2 products, RLD, RS
BYDUREON BCISEAstraZenecaN-209210 RX2017-10-20
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
bydureon bciseNew Drug Application2022-06-10
byettaNew Drug Application2020-02-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
type 2 diabetes mellitusEFO_0001360D003924E11
Agency Specific
FDA
EMA
Expiration
Code
EXENATIDE SYNTHETIC, BYDUREON, ASTRAZENECA AB
2025-01-22PED
2024-07-22NPP
2023-08-15PED
EXENATIDE SYNTHETIC, BYDUREON BCISE, ASTRAZENECA AB
2025-01-22PED
2024-07-22NPP
2023-08-15PED
EXENATIDE SYNTHETIC, BYDUREON PEN, ASTRAZENECA AB
2025-01-22PED
2024-07-22NPP
2023-08-15PED
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
87216152030-01-18DP
89988762030-01-07DP
86908372029-05-19DP
88279632029-02-04DP
84398642028-03-25DP
93208532028-03-25DP
83619722028-03-21U-2588
82161802028-01-12DP
87582922027-11-12DP
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
75638712024-04-15DP
92380762024-04-15DPU-2588, U-2589, U-2590, U-2597, U-2599, 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
298 clinical trials
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Mock data
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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_0001360E111819634623163
ObesityD009765EFO_0001073E66.94799330
Diabetes mellitusD003920EFO_0000400E08-E133512413
Type 1 diabetes mellitusD003922EFO_0001359E102723112
Healthy volunteers/patients—4——329
Glucose intoleranceD018149HP_0000833R73.03———7—7
Polycystic ovary syndromeD011085EFO_0000660E28.2—223—6
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.81—113—4
Myocardial infarctionD009203EFO_0000612I21—1—3—4
Gestational diabetesD016640HP_0009800O24.4———213
Show 24 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypoglycemiaD007003HP_0001943E16.2331—15
Parkinson diseaseD010300EFO_0002508G20131——5
CraniopharyngiomaD003397—11——2
Morbid obesityD009767EFO_0001074—21——2
Pediatric obesityD063766——1——1
St elevation myocardial infarctionD000072657——1——1
Chronic renal insufficiencyD051436N18——1——1
Left ventricular dysfunctionD018487——1——1
Metabolic syndromeD024821EFO_0000195E88.81——1——1
Coronary artery diseaseD003324I25.1——1——1
Show 2 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InsulinomaD00734051——16
AlcoholismD000437EFO_0003829F10.121———3
Smoking cessationD016540EFO_000431922———3
Ischemic strokeD000083242—2———2
StrokeD020521EFO_0000712I63.9—1——12
Cocaine-related disordersD019970F1421———2
Autoimmune diseasesD001327EFO_0000540M30-M3611———1
Multiple system atrophyD019578—1———1
Septic shockD012772A48.311———1
InflammationD00724911———1
Show 4 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Congenital hyperinsulinismD0449031———12
Renal insufficiencyD051437HP_0000083N191———12
NesidioblastosisD046768EFO_0007318E16.91————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperinsulinismD006946HP_0000842E16.1————33
Prader-willi syndromeD011218Orphanet_739Q87.11————22
Coronary diseaseD003327————11
Aortic valve diseaseD000082862————11
Cardiogenic shockD012770R57.0————11
Heart arrestD006323EFO_0009492I46————11
ComaD003128HP_0001259R40.2————11
Wolfram syndromeD014929Orphanet_3463E13.8————11
Sleep apnea syndromesD012891EFO_0003877G47.3————11
HyperlipidemiasD006949EFO_0003774E78.5————11
Show 3 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)
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
RxCUI60548
ChEMBL IDCHEMBL414357
ChEBI ID—
PubChem CID45588096
DrugBankDB01276
UNII ID9P1872D4OL (ChemIDplus, GSRS)
Target
Agency Approved
GLP1R
GLP1R
Organism
Homo sapiens
Gene name
GLP1R
Gene synonyms
NCBI Gene ID
2740
Protein name
glucagon-like peptide 1 receptor
Protein synonyms
GLP-1 receptor, GLP1 receptor, seven transmembrane helix receptor
Uniprot ID
Q99669
Mouse ortholog
Glp1r (14652)
glucagon-like peptide 1 receptor (Q1JQR8)
Alternate
No data
Variants
Clinical Variant
No data
Financial
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
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,094 documents
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Safety
Black-box Warning
Black-box warning for: Bydureon bcise
Adverse Events
Top Adverse Reactions
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80,586 adverse events reported
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