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Gattex kit, Revestive(teduglutide)
Gattex, Revestive (teduglutide) is a protein pharmaceutical. Teduglutide was first approved as Revestive on 2012-08-30. It is used to treat short bowel syndrome in the USA. It has been approved in Europe to treat malabsorption syndromes. The pharmaceutical is active against glucagon-like peptide 2 receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
nutritional and metabolic diseasesD009750
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Gattex
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Teduglutide recombinant
Tradename
Company
Number
Date
Products
GATTEX KITTakedaN-203441 RX2012-12-21
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
gattexNew Drug Application2021-02-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
short bowel syndrome—D012778—
Agency Specific
FDA
EMA
Expiration
Code
TEDUGLUTIDE RECOMBINANT, GATTEX KIT, TAKEDA PHARMS USA
2026-05-16ODE-240
Patent Expiration
Patent
Expires
Flag
FDA Information
Teduglutide Recombinant, Gattex Kit, Takeda Pharms Usa
78470612025-11-01U-1320
90609922025-11-01U-1320
ATC Codes
A: Alimentary tract and metabolism drugs
— A16: Other alimentary tract and metabolism products in atc
— A16A: Other alimentary tract and metabolism products in atc
— A16AX: Various alimentary tract and metabolism products
— A16AX08: Teduglutide
HCPCS
No data
Clinical
Clinical Trials
38 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Short bowel syndromeD012778——152522
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperlipidemiasD006949EFO_0003774E78.5—33——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Crohn diseaseD003424EFO_0000384K50—2———2
MalnutritionD044342EFO_0008572E40-E46—1———1
HivD006678O98.7—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—3————3
Graft vs host diseaseD006086D89.811————1
Renal insufficiencyD051437HP_0000083N191————1
Hepatic insufficiencyD0485501————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTEDUGLUTIDE
INNteduglutide
Description
Teduglutide is a 33-membered polypeptide consisting of 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 and Asp residues joined in sequence. A glucagon-like peptide-2 receptor agonist used for the treatment of short-bowel syndrome. It has a role as a glucagon-like peptide-2 receptor agonist, a metabolite, an antioxidant and a protective agent.
Classification
Protein
Drug classpeptides: glucagon-like peptide (GLP) analogs
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(=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
Identifiers
PDB—
CAS-ID197922-42-2
RxCUI1364468
ChEMBL IDCHEMBL2104987
ChEBI ID72305
PubChem CID16139605
DrugBankDB08900
UNII ID7M19191IKG (ChemIDplus, GSRS)
Target
Agency Approved
GLP2R
GLP2R
Organism
Homo sapiens
Gene name
GLP2R
Gene synonyms
NCBI Gene ID
9340
Protein name
glucagon-like peptide 2 receptor
Protein synonyms
epididymis secretory sperm binding protein, GLP-2 receptor
Uniprot ID
Q4VAT3
Mouse ortholog
Glp2r (93896)
glucagon-like peptide 2 receptor (Q5SU65)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Gattex - Takeda
$
€
£
₣
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Gattex - Shire
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 503 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3 adverse events reported
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