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pramlintide

Trade name: symlin

Peptideapproved

Approved

Mar 16, 2005

Pramlintide is an analog of human amylin. Amylin is co-secreted with insulin from pancreatic beta cells and acts centrally to slow gastric emptying, suppress postprandial glucagon secretion, and decrease food intake. These actions complement those of insulin to regulate blood glucose concentrations. Amylin is relatively deficient in patients with type 2 diabetes, depending on the severity of beta-cell secretory failure, and is essentially absent in patients with type 1 diabetes. Through mechanisms similar to those of amylin, pramlintide improves overall glycemic control, reduces postprandial glucose levels, and reduces bodyweight in patients with diabetes using mealtime insulin. SYMLIN® (pramlintide acetate) is indicated for patients with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy. — NCATS

Clinical trial activity

54 trials · 33 clinical orgs · 2 marketing orgs

Phase 1
8
Phase 2
23
Phase 3
9
Phase 4
10

Earliest trial started Apr 1, 2002 (NCT00042458)

Timeline

2000s

  1. Jan 1, 2002

    AstraZeneca — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2002

    AstraZeneca — Earliest Phase 3 Sponsor(trial)

  3. Mar 16, 2005

    Amylin — Earliest FDA Approval

  4. Mar 16, 2005

    AstraZeneca — NDA Secondary Org

  5. Mar 16, 2005

    Amylin — NDA Organization

  6. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedMar 16, 2005

Chemistry & pharmacology

Loading structure…

SMILES

CC[C@H](C)[C@H](NC(=O)[C@@H]1CCCN1C(=O)CNC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]cn1)NC(=O)[C@@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@@H]1CSSC[C@H](NC(=O)[C@@H](N)CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](C)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1)[C@@H](C)O)C(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@H](C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H](C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H](C(=O)N[C@@H](Cc1ccc(O)cc1)C(N)=O)[C@@H](C)O)C(C)C)[C@@H](C)O
Mol. weight
3949.45 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

  • ac0137
  • ac0137
  • ac 0137
  • ac 137
  • lys-cys-asn-thr-ala-thr-cys-ala-thr-gln-arg-leu-ala-asn-phe-leu-val-his-ser-ser-asn-asn-phe-gly-pro-ile-leu-pro-pro-thr-asn-val-gly-ser-asn-thr-tyr-nh2
  • pramlintide
  • pramlintide
  • pramlintide
  • pramlintide
  • pramlintide
  • pramlintide
  • pramlintide
  • pramlintide
  • pramlintide
  • pramlintide acetate
  • pramlintide acetate
  • pramlintide acetate
  • pramlintide acetate
  • pramlintide acetate
  • symlin
  • symlin
  • symlin
  • symlin
  • symlin
  • symlinpen
  • tripro-amylin
  • tripro-amylin
  • tripro-amylin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06619015Phase 2/Phase 3 (Phase 3)Oct 31, 2024University of Southern Denmark
NCT06186063N/AFeb 1, 2024University of Copenhagen
NCT06046417Phase 2/Phase 3 (Phase 3)Nov 30, 2023Juvenile Diabetes Research Foundation, McGill University
NCT05199714N/AFeb 21, 2022Juvenile Diabetes Research Foundation, McGill University
NCT04816890Phase 2Mar 23, 2021Adocia, Profil GmbH
NCT04243629N/AApr 30, 2020Canadian Institutes of Health Research (CIHR), McGill University
NCT04252612Early Phase 1 (Phase 1)Jan 30, 2020University of South Florida
NCT04163874N/ADec 15, 2019Juvenile Diabetes Research Foundation, McGill University
NCT04074317Phase 2Aug 20, 2019Worldwide Clinical Trials, Xeris Pharmaceuticals
NCT03981627Phase 1/Phase 2 (Phase 2)Jun 30, 2019Adocia, Profil GmbH
NCT03993366N/AMar 1, 2019Juvenile Diabetes Research Foundation, McGill University
NCT03916640Phase 1Jan 4, 2019Adocia, Profil GmbH
NCT03560960Early Phase 1 (Phase 1)Aug 6, 2018Boston University, National Institute on Aging (NIA)
NCT03598075N/AJul 1, 2018University of Copenhagen
NCT03547427N/AMay 20, 2018University of Virginia
NCT03512236Phase 1Apr 25, 2018Adocia, Profil GmbH
NCT02500979Phase 1Aug 1, 2015AstraZeneca, Juvenile Diabetes Research Foundation
NCT01841359Phase 4Jun 1, 2013Bristol-Myers Squibb, Joslin Diabetes Center
NCT01708044Phase 1Nov 1, 2012AstraZeneca, Juvenile Diabetes Research Foundation
NCT01434862N/AFeb 1, 2011The Paul Manning Foundation, University of Virginia
Showing 20 of 54 trials
Page 1 / 3

Organizations

Research & Development (33)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AmylinFor profit21042002
AstraZenecaFor profit191942002
Baylor UniversityAcademic/Hospital6622002
Juvenile Diabetes Research FoundationAcademic/Hospital6032012
McGill UniversityAcademic/Hospital5522019
AdociaFor profit4422018
Profil GmbHFor profit4022018
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government2012009
The University of Texas, DallasAcademic/Hospital2212007
University of Colorado, DenverAcademic/Hospital2222006
University of CopenhagenAcademic/Hospital2212018
University of VirginiaAcademic/Hospital2212011
Yeshiva UniversityAcademic/Hospital2122009
Boston UniversityAcademic/Hospital1112018
Bristol-Myers SquibbFor profit1012013
Canadian Institutes of Health Research (CIHR)Academic/Hospital1012020
Diabetes Care CenterAcademic/Hospital1112007
Joslin Diabetes CenterAcademic/Hospital1112013
Ludwig Maximilians UniversityAcademic/Hospital1112005
National Institute on Aging (NIA)Government1012018
33 organizations
Page 1 / 2

Marketing (2)

OrganizationOrg typeRelationshipDate
AmylinFor profitNDAMar 16, 2005
AstraZenecaFor profitNDA2Mar 16, 2005