teduglutide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
Glucagon-like Peptide (GLP) analogues 4718 197922-42-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • revestive
  • teduglutide
  • gattex
  • ALX-0600
  • teduglutide recombinant
an analogue of human glucagon-like peptide-2 (GLP-2) preserves mucosal integrity by promoting repair and normal growth of the intestine through an increase of villus height and crypt depth
  • Molecular weight: 3752.13
  • Formula: C164H252N44O55S
  • CLOGP:
  • LIPINSKI: None
  • HAC: 99
  • HDO: 55
  • TPSA: 1624.22
  • ALOGS:
  • ROTB: 125

Drug dosage:

DoseUnitRoute
5 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
June 23, 2021 PMDA TAKEDA PHARMACEUTICAL COMPANY LIMITED
Aug. 30, 2012 EMA NPS Pharma Holdings Limited
Dec. 21, 2012 FDA NPS PHARMS INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Vascular device infection 411.21 29.34 86 3028 4298 50597712
Stoma complication 194.14 29.34 30 3084 249 50601761
Device related sepsis 185.57 29.34 43 3071 3432 50598578
Hospitalisation 140.73 29.34 73 3041 67864 50534146
Device related infection 113.35 29.34 44 3070 20691 50581319
Gastrointestinal stoma output increased 105.48 29.34 17 3097 189 50601821
Abdominal pain 87.71 29.34 89 3025 236139 50365871
Dehydration 74.64 29.34 67 3047 152382 50449628
Weight decreased 74.22 29.34 79 3035 221166 50380844
Abdominal distension 68.19 29.34 47 3067 72856 50529154
Sepsis 58.35 29.34 55 3059 132870 50469140
Device related bacteraemia 57.66 29.34 9 3105 80 50601930
Therapy interrupted 57.53 29.34 27 3087 20125 50581885
Product dose omission issue 56.93 29.34 63 3051 183775 50418235
Product availability issue 51.83 29.34 14 3100 2074 50599936
Intestinal obstruction 42.35 29.34 24 3090 26359 50575651
Bacteraemia 37.10 29.34 18 3096 14415 50587595
Flatulence 32.32 29.34 21 3093 29437 50572573
Gastrointestinal stoma output abnormal 31.97 29.34 5 3109 45 50601965
Weight fluctuation 31.49 29.34 13 3101 7135 50594875
Abnormal faeces 30.55 29.34 11 3103 4185 50597825
Inappropriate schedule of product administration 30.07 29.34 29 3085 71802 50530208
Enterocutaneous fistula 29.67 29.34 8 3106 1176 50600834
Small intestinal obstruction 29.57 29.34 16 3098 16052 50585958

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Vascular device infection 467.62 40.15 88 1841 2417 29570181
Device related infection 158.11 40.15 53 1876 15583 29557015
Device related sepsis 153.46 40.15 35 1894 2460 29570138
Hospitalisation 132.76 40.15 63 1866 45925 29526673
Stoma complication 82.69 40.15 14 1915 202 29572396
Complication associated with device 74.50 40.15 23 1906 5168 29567430
Large intestine polyp 61.46 40.15 21 1908 6488 29566110
Device breakage 58.48 40.15 15 1914 1719 29570879
Gastrointestinal stoma output increased 57.31 40.15 8 1921 27 29572571
Duodenal polyp 51.76 40.15 9 1920 153 29572445
Weight decreased 44.86 40.15 52 1877 150853 29421745
Device related bacteraemia 44.63 40.15 8 1921 163 29572435
Product dose omission issue 44.39 40.15 42 1887 96341 29476257
Nephrolithiasis 42.00 40.15 24 1905 25310 29547288
Abdominal pain 40.80 40.15 47 1882 135310 29437288

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Vascular device infection 759.81 29.81 154 4191 6026 64488361
Device related sepsis 307.67 29.81 71 4274 5084 64489303
Device related infection 241.43 29.81 87 4258 30539 64463848
Stoma complication 196.48 29.81 33 4312 437 64493950
Gastrointestinal stoma output increased 130.15 29.81 21 4324 213 64494174
Abdominal pain 104.11 29.81 116 4229 312259 64182128
Hospitalisation 101.25 29.81 63 4282 75144 64419243
Device related bacteraemia 95.67 29.81 17 4328 318 64494069
Bacteraemia 79.59 29.81 38 4307 26873 64467514
Duodenal polyp 72.52 29.81 13 4332 256 64494131
Sepsis 70.54 29.81 82 4263 230259 64264128
Large intestine polyp 67.70 29.81 26 4319 10811 64483576
Dehydration 66.08 29.81 77 4268 216686 64277701
Complication associated with device 62.66 29.81 27 4318 15053 64479334
Weight decreased 62.50 29.81 86 4259 285653 64208734
Nephrolithiasis 62.30 29.81 38 4307 43645 64450742
Product dose omission issue 60.70 29.81 70 4275 194677 64299710
Abdominal distension 58.95 29.81 50 4295 95944 64398443
Intestinal obstruction 58.07 29.81 34 4311 36252 64458135
Enterocutaneous fistula 49.78 29.81 13 4332 1544 64492843
Gastrointestinal stoma complication 49.68 29.81 14 4331 2212 64492175
Flatulence 48.23 29.81 30 4315 35636 64458751
Abnormal faeces 47.40 29.81 17 4328 5842 64488545
Therapy interrupted 46.48 29.81 24 4321 20012 64474375
Catheter site infection 36.77 29.81 14 4331 5679 64488708
Stoma site haemorrhage 35.34 29.81 10 4335 1603 64492784
Small intestinal obstruction 34.85 29.81 21 4324 23552 64470835
Device breakage 34.15 29.81 15 4330 8740 64485647
COVID-19 34.08 29.81 31 4314 65109 64429278
Gastric polyps 33.31 29.81 11 4334 2954 64491433
Gastrointestinal bacterial overgrowth 32.80 29.81 7 4338 347 64494040
Device dislocation 31.66 29.81 19 4326 21159 64473228
Vascular device occlusion 31.52 29.81 5 4340 45 64494342

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A16AX08 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Various alimentary tract and metabolism products
FDA Chemical/Ingredient N0000175140 Glucagon-Like Peptide 2
FDA Chemical/Ingredient N0000175452 Analogs/Derivatives
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D020011 Protective Agents
MeSH PA D011837 Radiation-Protective Agents
FDA MoA N0000190990 Glucagon-like Peptide-2 (GLP-2) Agonists
FDA EPC N0000190992 GLP-2 Analog
CHEBI has role CHEBI:22586 antioxidants
CHEBI has role CHEBI:25212 metabolites
CHEBI has role CHEBI:50267 protective agents
CHEBI has role CHEBI:72311 glucagon-like peptide-2 receptor agonists

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Short bowel syndrome indication 26629001 DOID:10605




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.81 acidic
pKa2 3.1 acidic
pKa3 3.51 acidic
pKa4 3.79 acidic
pKa5 4.07 acidic
pKa6 4.58 acidic
pKa7 5.16 acidic
pKa8 12.12 acidic
pKa9 12.14 acidic
pKa10 12.47 acidic
pKa11 12.53 acidic
pKa12 12.69 acidic
pKa13 12.83 acidic
pKa14 12.86 acidic
pKa15 12.87 acidic
pKa16 13.05 acidic
pKa17 13.1 acidic
pKa18 13.22 acidic
pKa19 13.41 acidic
pKa20 13.45 acidic
pKa21 13.46 acidic
pKa22 13.54 acidic
pKa23 13.75 acidic
pKa24 13.8 acidic
pKa25 13.87 acidic
pKa26 13.9 acidic
pKa27 11.08 Basic
pKa28 10.48 Basic
pKa29 7.86 Basic
pKa30 5.98 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 7056886 Sept. 18, 2022 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 7847061 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9060992 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9539310 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9545434 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9545435 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9555079 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9572867 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9592273 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9592274 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9968655 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9968656 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9968658 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9974835 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9974837 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9981014 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9981016 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9987334 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9987335 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS 9993528 Nov. 1, 2025 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
5MG/VIAL GATTEX KIT TAKEDA PHARMS USA N203441 Dec. 21, 2012 RX POWDER SUBCUTANEOUS May 16, 2026 TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glucagon-like peptide 2 receptor GPCR AGONIST EC50 10.05 CHEMBL CHEMBL
Glucagon-like peptide 2 receptor GPCR EC50 10.10 CHEMBL

External reference:

IDSource
D06053 KEGG_DRUG
4032133 VUID
N0000186572 NUI
4032133 VANDF
CHEBI:72305 CHEBI
CHEMBL2104987 ChEMBL_ID
C494910 MESH_SUPPLEMENTAL_RECORD_UI
C438272 MESH_SUPPLEMENTAL_RECORD_UI
7049 IUPHAR_LIGAND_ID
8444 INN_ID
DB08900 DRUGBANK_ID
7M19191IKG UNII
16139605 PUBCHEM_CID
1364468 RXNORM
196699 MMSL
29024 MMSL
d07938 MMSL
014819 NDDF
710807004 SNOMEDCT_US
715636000 SNOMEDCT_US
C1530889 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Gattex HUMAN PRESCRIPTION DRUG LABEL 1 68875-0101 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 5 mg SUBCUTANEOUS NDA 30 sections