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Drug ReportsTeduglutide
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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Target
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Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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
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 Application2024-09-27
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
short bowel syndrome—D012778K90.82
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
46 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—K90.82——1631029
SyndromeD013577————163726
ThrombosisD013927—————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperlipidemiasD006949HP_0003077E78.5—44——4
OstomyD010030————1——1
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
Severe acute malnutritionD000067011———1———1
HivD006678———1———1
InflammationD007249MP_0001845——1———1
Intestinal fistulaD007412—K63.2—1———1
FistulaD005402———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 diseaseD006086—D89.811————1
Renal insufficiencyD051437HP_0000083N191————1
Hepatic insufficiencyD048550——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Intestinal failureD000090124——————22
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)Loading
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
RxCUI—
ChEMBL IDCHEMBL2104987
ChEBI ID72305
PubChem CID16139605
DrugBank—
UNII ID7M19191IKG (ChemIDplus, GSRS)
Target
Agency Approved
GLP2R
GLP2R
Organism
Homo sapiens
Gene name
GLP2R
Gene synonyms
NCBI Gene ID
Protein name
glucagon-like peptide 2 receptor
Protein synonyms
epididymis secretory sperm binding protein, GLP-2 receptor
Uniprot ID
Mouse ortholog
Glp2r (93896)
glucagon-like peptide 2 receptor (Q5SU65)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Gattex – Takeda
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Gattex – Shire
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 611 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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10,969 adverse events reported
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