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exenatide

Trade name: byetta

Peptideapproved

Approved

Apr 28, 2005

Exenatide (exendin-4) is sold under the brand name BYETTA to improve glycemic control in people with type 2 diabetes mellitus. Exenatide is a glucagon-like peptide 1 (GLP-1) receptor agonist that enhances glucose-dependent insulin secretion by the pancreatic beta cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying. The drug also moderates peak serum glucagon levels during hyperglycemic periods following meals but does not interfere with glucagon release in response to hypoglycemia. — NCATS

Clinical trial activity

290 trials · 179 clinical orgs · 3 marketing orgs

Phase 1
46
Phase 2
132
Phase 3
89
Phase 4
84

Earliest trial started Feb 1, 2002 (NCT00039026)

Timeline

2000s

  1. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2002

    AstraZeneca — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2005

    AstraZeneca — Earliest Phase 1 Sponsor(trial)

  4. Apr 28, 2005

    Amylin — Earliest FDA Approval

  5. Apr 28, 2005

    AstraZeneca — NDA Secondary Org

  6. Apr 28, 2005

    Amylin — NDA Organization

2020s

  1. Nov 19, 2024

    Amneal Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedApr 28, 2005

Chemistry & pharmacology

Loading structure…

SMILES

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
Mol. weight
4186.64 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • ac002993
  • ac002993
  • ac002993
  • ac002993
  • ac2993
  • ac2993
  • ac2993
  • ac 2993
  • ac 2993
  • ac 2993
  • ac-2993
  • ac-2993
  • ac2993a
  • ac2993a
  • ac2993a
  • ac2993a
  • ac 2993 lar
  • bydureon
  • bydureon
  • bydureon
  • bydureon
  • bydureon
  • byetta
  • byetta
  • byetta
  • byetta
  • byetta
  • ex4 peptide
  • exantide
  • exenatide
  • exenatide
  • exenatide
  • exenatide
  • exenatide
  • exenatide
  • exenatide
  • exenatide
  • exenatide
  • exenatide
  • exenatide
  • exenatide
  • exenatide synthetic
  • exenatide synthetic
  • exenatide synthetic
  • exenatide synthetic
  • exenatide synthetic
  • exendin 4
  • exendin-4
  • exendin-4
  • itca 650
  • pb-119
  • rexenatide
  • spil1033
  • synthetic exendin-4

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06252623Phase 1Aug 1, 2024Baylor University
NCT06350812Phase 1/Phase 2 (Phase 2)May 27, 2024Central South University, PegBio Co., Ltd.
NCT05670379Phase 1Mar 31, 2024Medpace, Inc., Vivani Medical
NCT05990374N/AAug 1, 2023Nanjing Medical University
NCT05482789Phase 4Jan 1, 2023University of Pittsburgh
NCT05610800Phase 2Nov 30, 2022University of Texas at Houston
NCT05347147Phase 3Nov 18, 2022Invex Therapeutics Ltd., Premier Research Group
NCT05356104Phase 2May 25, 2022Chinese University of Hong Kong
NCT05328843Phase 1May 1, 2022PegBio Co., Ltd., Sichuan University
NCT04941521Phase 1/Phase 2 (Phase 2)Jul 1, 2021University of Texas at Houston
NCT04897802Phase 4Jun 1, 2021Universidad Carlos III Madrid, University of Barcelona
NCT04909333N/AApr 29, 2021Gottfried und Julia Bangerter-Rhyner Foundation, Switzerland, University of Basel
NCT04969627Phase 4Jan 1, 2021Shengjing Hospital
NCT04520490Phase 3Dec 1, 2020University of Washington
NCT04431713Phase 2Jun 27, 2020University of London
NCT04307797Phase 4Jun 1, 2020Antaros Medical AB, University of Cambridge
NCT04269642Phase 2Feb 29, 2020Peptron, Inc.
NCT04305002Phase 2Jan 21, 2020Center for Neurology, Stockholm, Karolinska Institute
NCT04232969Phase 3Jan 20, 2020University of London
NCT04154072Phase 2Dec 31, 2019Neuraly, Inc
Showing 20 of 290 trials
Page 1 / 15

Organizations

Research & Development (179)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstraZenecaFor profit846852002
Eli LillyFor profit70452002
AmylinFor profit34052002
Intarcia TherapeuticsFor profit141432009
Baylor UniversityAcademic/Hospital9842007
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government9132003
University of CopenhagenAcademic/Hospital9942009
PegBio Co., Ltd.For profit8822014
University of MinnesotaAcademic/Hospital7532007
Department of Veteran AffairsGovernment6422006
Peking UniversityAcademic/Hospital6032011
Free University of AmsterdamAcademic/Hospital5122009
GlaxoSmithKlineFor profit5532005
Jiao Tong UniversityAcademic/Hospital5212014
Novo NordiskFor profit5522006
SanofiFor profit5242008
University of AmsterdamAcademic/Hospital5532009
University of LondonAcademic/Hospital5532010
University of Texas, San AntonioAcademic/Hospital5522007
Bristol-Myers SquibbFor profit4142007
179 organizations
Page 1 / 9

Marketing (3)

OrganizationOrg typeRelationshipDate
Amneal PharmaceuticalsFor profitMKTGNov 19, 2024
AmylinFor profitNDAApr 28, 2005
AstraZenecaFor profitNDA2Apr 28, 2005