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

Stem definitionDrug idCAS RN
glucagon-like peptide (GLP) analogues and agonists 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 992.83 24.37 220 7628 7092 63474082
Stoma complication 315.05 24.37 55 7793 480 63480694
Device related sepsis 285.79 24.37 72 7776 4022 63477152
Device related infection 282.97 24.37 107 7741 23285 63457889
Hospitalisation 260.41 24.37 150 7698 84931 63396243
Gastrointestinal stoma output increased 206.60 24.37 36 7812 310 63480864
Weight decreased 173.24 24.37 191 7657 276607 63204567
Device related bacteraemia 161.03 24.37 27 7821 180 63480994
Abdominal distension 159.94 24.37 111 7737 86504 63394670
Product dose omission issue 138.38 24.37 157 7691 234156 63247018
Abdominal pain 136.32 24.37 174 7674 293282 63187892
Dehydration 135.73 24.37 135 7713 173219 63307955
Therapy interrupted 106.52 24.37 60 7788 32395 63448779
Sepsis 104.82 24.37 111 7737 153012 63328162
Intestinal obstruction 103.79 24.37 58 7790 30841 63450333
Product availability issue 92.84 24.37 30 7818 4091 63477083
Gastrointestinal stoma complication 87.88 24.37 24 7824 1831 63479343
Flatulence 82.18 24.37 52 7796 34650 63446524
Small intestinal obstruction 74.32 24.37 39 7809 18298 63462876
Inappropriate schedule of product administration 70.40 24.37 75 7773 103890 63377284
COVID-19 70.33 24.37 78 7770 113025 63368149
Abnormal faeces 69.56 24.37 26 7822 5454 63475720
Weight increased 60.13 24.37 112 7736 260680 63220494
Insurance issue 59.76 24.37 24 7824 6097 63475077
Gastrointestinal stoma output abnormal 59.59 24.37 10 7838 67 63481107
Bacteraemia 59.42 24.37 33 7815 17315 63463859
Obstruction 59.34 24.37 20 7828 3107 63478067
Weight fluctuation 58.01 24.37 27 7821 9792 63471382
Appetite disorder 52.35 24.37 23 7825 7298 63473876
Faeces hard 49.79 24.37 16 7832 2141 63479033
Blood magnesium decreased 47.65 24.37 26 7822 13172 63468002
Stoma site oedema 45.56 24.37 6 7842 3 63481171
Nephrolithiasis 44.92 24.37 39 7809 41945 63439229
Needle issue 44.71 24.37 23 7825 10353 63470821
Parenteral nutrition associated liver disease 43.84 24.37 6 7842 6 63481168
Enterocutaneous fistula 43.36 24.37 13 7835 1384 63479790
Product distribution issue 43.19 24.37 13 7835 1403 63479771
Duodenal polyp 41.11 24.37 8 7840 132 63481042
Stoma site inflammation 41.07 24.37 10 7838 483 63480691
Rash 38.30 24.37 11 7837 560860 62920314
Drug ineffective 38.24 24.37 44 7804 1044721 62436453
Complication associated with device 36.61 24.37 24 7824 16954 63464220
Overgrowth bacterial 35.78 24.37 7 7841 119 63481055
Vitamin A deficiency 35.62 24.37 5 7843 7 63481167
Stoma site pain 33.96 24.37 10 7838 1000 63480174
Stoma site haemorrhage 33.39 24.37 10 7838 1061 63480113
Injection site bruising 31.49 24.37 32 7816 41878 63439296
Catheter site inflammation 30.97 24.37 9 7839 860 63480314
Gastrointestinal bacterial overgrowth 30.84 24.37 9 7839 873 63480301
Fistula 30.82 24.37 18 7830 10375 63470799
Illness 30.73 24.37 34 7814 49025 63432149
Syringe issue 30.62 24.37 12 7836 2857 63478317
Blood magnesium abnormal 28.90 24.37 8 7840 641 63480533
Device related thrombosis 28.36 24.37 10 7838 1775 63479399
Abdominal pain upper 28.34 24.37 72 7776 206372 63274802
Stoma site abscess 27.48 24.37 6 7842 178 63480996
Ileus 27.40 24.37 19 7829 14706 63466468
Urinary tract infection 25.30 24.37 81 7767 264603 63216571

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 1150.26 31.82 228 4410 3957 34948336
Device related sepsis 290.68 31.82 70 4568 3023 34949270
Device related infection 266.00 31.82 96 4542 17141 34935152
Hospitalisation 209.75 31.82 116 4522 56786 34895507
Stoma complication 203.80 31.82 36 4602 313 34951980
Gastrointestinal stoma output increased 120.71 31.82 19 4619 73 34952220
Complication associated with device 113.69 31.82 39 4599 5967 34946326
Device related bacteraemia 97.48 31.82 20 4618 406 34951887
Weight decreased 95.70 31.82 117 4521 176184 34776109
Device breakage 89.95 31.82 26 4612 2274 34950019
Product dose omission issue 84.35 31.82 91 4547 119620 34832673
Stoma site haemorrhage 67.63 31.82 17 4621 873 34951420
Duodenal polyp 65.64 31.82 13 4625 219 34952074
Gastrointestinal stoma complication 65.57 31.82 18 4620 1304 34950989
Weight increased 64.18 31.82 70 4568 92963 34859330
Therapy interrupted 61.70 31.82 32 4606 13665 34938628
Nephrolithiasis 58.34 31.82 41 4597 30292 34922001
Gastrointestinal stoma output abnormal 56.94 31.82 8 4630 10 34952283
Flatulence 56.17 31.82 35 4603 21163 34931130
Abdominal pain 53.17 31.82 85 4553 163533 34788760
Abdominal distension 52.98 31.82 51 4587 58441 34893852
Large intestine polyp 52.21 31.82 24 4614 7890 34944403
Enterocutaneous fistula 50.90 31.82 14 4624 1021 34951272
Abnormal faeces 49.23 31.82 18 4620 3307 34948986
Product availability issue 46.67 31.82 15 4623 1872 34950421
Intestinal obstruction 44.22 31.82 31 4607 22791 34929502
Gastric polyps 44.13 31.82 13 4625 1213 34951080
Dehydration 42.82 31.82 68 4570 129901 34822392
COVID-19 42.73 31.82 52 4586 77498 34874795
Catheter site infection 41.97 31.82 15 4623 2582 34949711
Device dislocation 38.26 31.82 18 4620 6231 34946062
Gastrointestinal stoma output decreased 37.79 31.82 7 4631 81 34952212
Vascular device occlusion 37.31 31.82 8 4630 202 34952091
Bacteraemia 36.38 31.82 26 4612 19691 34932602
Stoma obstruction 36.19 31.82 6 4632 34 34952259
Parenteral nutrition 35.70 31.82 5 4633 6 34952287
Device malfunction 34.86 31.82 20 4618 10401 34941892
Central venous catheterisation 34.57 31.82 11 4627 1328 34950965
Inappropriate schedule of product administration 33.04 31.82 41 4597 62255 34890038

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 1822.51 22.82 387 9795 9889 79724317
Device related sepsis 554.43 22.82 134 10048 6106 79728100
Device related infection 513.56 22.82 185 9997 34109 79700097
Stoma complication 385.79 22.82 70 10112 749 79733457
Gastrointestinal stoma output increased 245.61 22.82 43 10139 368 79733838
Device related bacteraemia 222.63 22.82 43 10139 659 79733547
Hospitalisation 163.99 22.82 118 10064 94118 79640088
Abdominal pain 149.34 22.82 214 9968 389355 79344851
Weight decreased 137.35 22.82 196 9986 355002 79379204
Abdominal distension 134.94 22.82 116 10066 119534 79614672
Product dose omission issue 130.28 22.82 159 10023 247378 79486828
Dehydration 129.95 22.82 159 10023 248028 79486178
Complication associated with device 126.79 22.82 56 10126 17440 79716766
Gastrointestinal stoma complication 118.70 22.82 33 10149 2604 79731602
Sepsis 107.43 22.82 151 10031 269277 79464929
Intestinal obstruction 106.26 22.82 67 10115 42953 79691253
Duodenal polyp 102.84 22.82 20 10162 318 79733888
Flatulence 101.69 22.82 65 10117 42659 79691547
Abnormal faeces 98.89 22.82 37 10145 7534 79726672
Bacteraemia 96.10 22.82 57 10125 32767 79701439
Therapy interrupted 95.90 22.82 56 10126 31285 79702921
Enterocutaneous fistula 95.00 22.82 26 10156 1935 79732271
Nephrolithiasis 90.94 22.82 66 10116 53225 79680981
Gastrointestinal stoma output abnormal 89.23 22.82 15 10167 98 79734108
Product availability issue 89.07 22.82 29 10153 3918 79730288
COVID-19 79.13 22.82 99 10083 157575 79576631
Stoma site haemorrhage 72.77 22.82 21 10161 1895 79732311
Faeces hard 68.47 22.82 22 10160 2849 79731357
Small intestinal obstruction 66.14 22.82 42 10140 27230 79706976
Large intestine polyp 62.11 22.82 31 10151 12677 79721529
Obstruction 61.92 22.82 23 10159 4587 79729619
Weight increased 59.77 22.82 118 10064 277268 79456938
Device breakage 58.03 22.82 28 10154 10647 79723559
Gastrointestinal stoma output decreased 57.47 22.82 11 10171 160 79734046
Stoma site pain 55.46 22.82 16 10166 1442 79732764
Device related thrombosis 53.67 22.82 18 10164 2665 79731541
Stoma obstruction 52.92 22.82 11 10171 248 79733958
Weight fluctuation 52.73 22.82 27 10155 11648 79722558
Gastric polyps 51.45 22.82 19 10163 3728 79730478
Drug ineffective 50.21 22.82 39 10143 1080874 78653332
Fistula 50.11 22.82 27 10155 12913 79721293
Catheter site infection 50.02 22.82 22 10160 6773 79727433
Vascular device occlusion 49.55 22.82 11 10171 341 79733865
Inappropriate schedule of product administration 48.88 22.82 72 10110 133556 79600650
Needle issue 47.10 22.82 26 10156 13042 79721164
Stoma site inflammation 46.96 22.82 12 10170 684 79733522
Staphylococcal infection 45.30 22.82 46 10136 58249 79675957
Gastrointestinal bacterial overgrowth 42.07 22.82 11 10171 687 79733519
Parenteral nutrition associated liver disease 41.92 22.82 6 10176 10 79734196
Drug interaction 41.52 22.82 3 10179 415180 79319026
Insurance issue 40.39 22.82 18 10164 5715 79728491
Stoma site oedema 40.17 22.82 7 10175 58 79734148
Device malfunction 39.86 22.82 28 10154 21420 79712786
Device dislocation 39.43 22.82 30 10152 25940 79708266
Rectal polyp 36.53 22.82 12 10170 1665 79732541
Malnutrition 36.39 22.82 27 10155 22475 79711731
Staphylococcal bacteraemia 35.18 22.82 21 10161 12197 79722009
Urinary tract infection 34.95 22.82 95 10087 274417 79459789
Product distribution issue 34.66 22.82 11 10171 1369 79732837
Off label use 33.59 22.82 40 10142 907175 78827031
Catheter site inflammation 32.44 22.82 10 10172 1131 79733075
Cholecystitis 32.27 22.82 25 10157 22187 79712019
Vitamin A deficiency 31.30 22.82 6 10176 88 79734118
Ileus 30.68 22.82 26 10156 26185 79708021
Klebsiella bacteraemia 29.69 22.82 12 10170 2998 79731208
Injection site bruising 29.40 22.82 31 10151 40971 79693235
Blood magnesium decreased 29.40 22.82 21 10161 16491 79717715
Urine output increased 29.36 22.82 11 10171 2245 79731961
Rash 29.20 22.82 19 10163 578339 79155867
Faecal volume increased 28.98 22.82 7 10175 316 79733890
Hypokalaemia 28.25 22.82 59 10123 143981 79590225
Device occlusion 28.08 22.82 18 10164 11848 79722358
Anastomotic ulcer 27.64 22.82 8 10174 729 79733477
Stoma site dermatitis 27.15 22.82 4 10178 9 79734197
Product packaging quantity issue 26.78 22.82 9 10173 1340 79732866
Intestinal polyp 26.44 22.82 10 10172 2094 79732112
Gastrointestinal tract adenoma 25.93 22.82 7 10175 494 79733712
Stoma site abscess 25.36 22.82 6 10176 248 79733958
Central venous catheterisation 25.35 22.82 11 10171 3278 79730928
Subileus 25.31 22.82 13 10169 5641 79728565
Jugular vein thrombosis 24.95 22.82 12 10170 4526 79729680
Brachiocephalic vein thrombosis 24.93 22.82 6 10176 267 79733939
Gastric mucosal hypertrophy 24.86 22.82 6 10176 270 79733936
Gastroenteritis 24.85 22.82 26 10156 34056 79700150
Illness 24.56 22.82 30 10152 46481 79687725
Hypotension 24.28 22.82 13 10169 440304 79293902
Abdominal pain upper 24.14 22.82 73 10109 223746 79510460
Syringe issue 23.99 22.82 13 10169 6285 79727921
Small intestine polyp 23.81 22.82 4 10178 26 79734180
Biliary dilatation 23.72 22.82 10 10172 2776 79731430
Gastrointestinal fistula 22.97 22.82 7 10175 762 79733444
Dyspnoea 22.90 22.82 47 10135 856978 78877228

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 | Suggest Off label Use Form| |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 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

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
1364468 RXNORM
196699 MMSL
29024 MMSL
d07938 MMSL
014819 NDDF
710807004 SNOMEDCT_US
715636000 SNOMEDCT_US
C1530889 UMLSCUI
16139605 PUBCHEM_CID

Pharmaceutical products:

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