CDEK
← All drugs Report issue

teduglutide

Trade name: gattex kit

PeptideapprovedOrphan Drug FDA

Approved

Dec 21, 2012

Teduglutide is a glucagon-like peptide-2 (GLP-2) analogue. It is made up of 33 amino acids and is manufactured using a strain of Escherichia coli modified by recombinant DNA technology. Teduglutide differs from GLP-2 by one amino acid (alanine is substituted by glycine). The significance of this substitution is that teduglutide is longer acting than endogenous GLP-2 as it is more resistant to proteolysis from dipeptidyl peptidase-4. GLP-2 is known to increase intestinal and portal blood flow, and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF). FDA approved on December 21, 2012. In Europe it has been granted orphan drug status and is marketed under the brand Revestive by Nycomed. It works by promoting mucosal growth and possibly restoring gastric emptying and secretion. — NCATS

Clinical trial activity

36 trials · 20 clinical orgs · 2 marketing orgs

Phase 1
8
Phase 2
22
Phase 3
22
Phase 4
2

Earliest trial started Oct 1, 2003 (NCT00072839)

Timeline

2000s

  1. Jun 29, 2000

    Orphan Drug Designation

  2. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

  4. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Dec 20, 2012

    NPS Pharma — First NDA Organization

  2. Dec 20, 2012

    NPS Pharma — NDA Organization

  3. Dec 21, 2012

    Earliest FDA Approval

  4. Dec 21, 2012

    Takeda — Marketing Organization

  5. Dec 21, 2012

    NPS Pharma — NDA Secondary Org

  6. Dec 21, 2012

    Takeda — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 21, 2012

Chemistry & pharmacology

Loading structure…

SMILES

CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CO)NC(=O)CNC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1c[nH]cn1)[C@@H](C)O)[C@@H](C)CC)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@H](C(=O)N[C@@H](CCCCN)C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@@H](CC(=O)O)C(=O)O)[C@@H](C)O)[C@@H](C)CC)[C@@H](C)O)[C@@H](C)CC
Mol. weight
3752.14 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Also known as

  • alx 0600
  • alx 0600
  • alx-0600
  • alx-0600
  • alx-0600
  • alx-0600
  • alx-0600
  • gattex
  • gattex
  • gattex
  • gattex kit
  • glucagon-like peptide ii (2-glycine) (human)
  • glucagon-like peptide ii (2-glycine) (human)
  • (gly2)glp-2
  • (gly2)glp-2
  • (gly2)glp-2
  • gly(2)-glp-2
  • gly(2)-glp-2
  • gly(2)-glp-2
  • hgdgsfsdemntildnlaardfinwliqtkitd
  • hgdgsfsdemntildnlaardfinwliqtkitd
  • his-gly-asp-gly-ser-phe-ser-asp-glu-met-asn-thr-ile-leu-asp-asn-leu-ala-ala-arg-asp-phe-ile-asn-trp-leu-ile-gln-thr-lys-ile-thr-asp
  • his-gly-asp-gly-ser-phe-ser-asp-glu-met-asn-thr-ile-leu-asp-asn-leu-ala-ala-arg-asp-phe-ile-asn-trp-leu-ile-gln-thr-lys-ile-thr-asp
  • revestive
  • revestive
  • revestive
  • revestive
  • revestive
  • tedguglutide
  • teduglutide
  • teduglutide
  • teduglutide
  • teduglutide
  • teduglutide
  • teduglutide
  • teduglutide
  • teduglutide
  • teduglutide
  • teduglutide
  • teduglutide [rdna origin]
  • teduglutide recombinant
  • teduglutide recombinant
  • teduglutide recombinant
  • teduglutide recombinant
  • teduglutide recombinant

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06973304Phase 3Jun 26, 2025Takeda
NCT05027308Phase 3Oct 1, 2021Takeda
NCT04465396Phase 1Mar 3, 2021Shire, Takeda
NCT03860688Phase 2/Phase 3 (Phase 3)May 31, 2019University of Toronto
NCT03953170Phase 3May 27, 2019Allegheny Health Network, Shire
NCT03716115Phase 2Jan 31, 2019Parirenyatwa Hospital, University of London, University Teaching Hospital, Lusaka, Zambia
NCT03663582Phase 3Nov 1, 2018Shire
NCT03571516Phase 3Aug 6, 2018Shire
NCT03596164Phase 3Jul 9, 2018Shire
NCT03562130Phase 4Jun 30, 2018Assistance Publique - Hôpitaux de Paris, Imagine Institute
NCT03422666Phase 2/Phase 3 (Phase 3)Jun 1, 2018University of Toronto
NCT03442972Phase 2/Phase 3 (Phase 3)Jun 1, 2018Kensington Health, University of Toronto
NCT04290429Early Phase 1 (Phase 1)Dec 6, 2017University of Freiburg
NCT03534661Phase 2/Phase 3 (Phase 3)Sep 27, 2017University of Toronto
NCT03268811Phase 3Aug 16, 2017Shire
NCT02889393Phase 1Jan 1, 2017Harvard University
NCT02980666Phase 3Jan 1, 2017Shire
NCT02954458Phase 3Jan 1, 2017Shire
NCT02949362Phase 3Nov 1, 2016Shire
NCT02682381Phase 3Jun 23, 2016Shire
Showing 20 of 36 trials
Page 1 / 2

Organizations

Research & Development (20)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ShireFor profit212032003
NPS PharmaFor profit9132003
NycomedFor profit4222008
University of TorontoAcademic/Hospital4412017
TakedaFor profit3222021
Harvard UniversityAcademic/Hospital2222015
Allegheny Health NetworkAcademic/Hospital1112019
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1112018
Imagine InstituteAcademic/Hospital1012018
Kensington HealthAcademic/Hospital1012018
Mayo ClinicAcademic/Hospital1112014
National Heart, Lung, and Blood Institute (NHLBI)Government1012015
National Institutes of Health (NIH)Government1012015
NPSFor profit1012004
Parirenyatwa HospitalAcademic/Hospital1012019
PRACSFor profit1012010
Ragon Institute of MGH, MIT and HarvardAcademic/Hospital1012015
University of FreiburgAcademic/Hospital1112017
University of LondonAcademic/Hospital1112019
University Teaching Hospital, Lusaka, ZambiaAcademic/Hospital1012019
20 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
NPS PharmaFor profitNDA2Dec 21, 2012
NPS PharmaFor profitNDADec 20, 2012
TakedaFor profitMKTGDec 21, 2012
TakedaFor profitNDA2Dec 21, 2012