dulaglutide Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
Glucagon-like Peptide (GLP) analogues 4885 923950-08-7

Description:

MoleculeDescription

Synonyms:

  • dulaglutide
  • trulicity
  • LY2189265
a glucagon-like peptide-1 receptor agonist; GLP-1 immunoglobulin G (IgG4) Fc fusion protein with extended activity
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
0.16 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Nov. 22, 2014 EMA
Sept. 18, 2014 FDA ELI LILLY AND CO

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
Nausea 477.49 21.35 621 8848 755470 52584127
Blood glucose increased 440.15 21.35 232 9237 77129 53262468
Injection site pain 392.67 21.35 246 9223 113145 53226452
Accidental underdose 350.23 21.35 66 9403 616 53338981
Glycosylated haemoglobin increased 240.74 21.35 87 9382 11568 53328029
Diabetic ketoacidosis 198.81 21.35 88 9381 19827 53319770
Vomiting 186.01 21.35 322 9147 496817 52842780
Extra dose administered 185.54 21.35 59 9410 5311 53334286
Inappropriate schedule of product administration 169.11 21.35 125 9344 74753 53264844
Pancreatitis 139.10 21.35 92 9377 46050 53293547
Incorrect dose administered 137.70 21.35 95 9374 50950 53288647
Injection site haemorrhage 130.27 21.35 68 9401 21983 53317614
Accidental overdose 126.21 21.35 66 9403 21413 53318184
Abdominal pain upper 120.88 21.35 148 9321 166143 53173454
Injection site pruritus 118.30 21.35 80 9389 41509 53298088
Product dose omission issue 111.84 21.35 153 9316 191467 53148130
Diabetic metabolic decompensation 104.99 21.35 29 9440 1599 53337998
Injection site erythema 104.90 21.35 96 9373 77153 53262444
Injection site mass 84.47 21.35 46 9423 16168 53323429
Product administered at inappropriate site 83.14 21.35 27 9442 2595 53337002
Hypoglycaemia 77.47 21.35 72 9397 58941 53280656
Injection site bruising 76.34 21.35 59 9410 37587 53302010
Blood glucose abnormal 71.88 21.35 32 9437 7287 53332310
Underdose 67.44 21.35 44 9425 21478 53318119
Diarrhoea 66.65 21.35 252 9217 625294 52714303
Injury associated with device 66.34 21.35 24 9445 3191 53336406
Injection site rash 64.80 21.35 39 9430 16540 53323057
Euglycaemic diabetic ketoacidosis 56.68 21.35 21 9448 2986 53336611
Blood glucose decreased 48.67 21.35 35 9434 19981 53319616
Transcription medication error 48.53 21.35 11 9458 267 53339330
Acute kidney injury 44.89 21.35 122 9347 253746 53085851
Injection site urticaria 40.04 21.35 26 9443 12581 53327016
Lactic acidosis 38.67 21.35 40 9429 37213 53302384
Pancreatitis acute 38.44 21.35 34 9435 26075 53313522
Pancreatic carcinoma 36.96 21.35 20 9449 6934 53332663
Ketoacidosis 36.07 21.35 17 9452 4409 53335188
Wrong technique in product usage process 34.98 21.35 48 9421 59984 53279613
Diabetes mellitus inadequate control 34.74 21.35 25 9444 14285 53325312
Eructation 34.68 21.35 20 9449 7835 53331762
Hyperglycaemic hyperosmolar nonketotic syndrome 34.62 21.35 10 9459 648 53338949
Weight decreased 32.03 21.35 103 9366 234845 53104752
Accidental exposure to product 31.26 21.35 29 9440 23645 53315952
Blood calcitonin increased 29.76 21.35 5 9464 22 53339575
Blood glucose fluctuation 29.64 21.35 15 9454 4536 53335061
Lipase increased 28.94 21.35 19 9450 9359 53330238
Rheumatoid arthritis 28.74 21.35 10 9459 314521 53025076
Thirst decreased 27.81 21.35 7 9462 268 53339329
Injection site injury 26.93 21.35 8 9461 572 53339025
Dehydration 26.83 21.35 78 9391 168332 53171265
Injection site swelling 26.21 21.35 35 9434 42593 53297004
COVID-19 25.36 21.35 32 9437 36856 53302741
Impaired gastric emptying 24.74 21.35 17 9452 9026 53330571
Decreased appetite 24.67 21.35 89 9380 214885 53124712
Toxicity to various agents 23.77 21.35 5 9464 219593 53120004
Hyperglycaemia 21.77 21.35 31 9438 40053 53299544

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
Blood glucose increased 356.39 21.38 214 7883 65027 32440402
Injection site pain 303.65 21.38 153 7944 32905 32472524
Accidental underdose 298.32 21.38 56 8041 348 32505081
Inappropriate schedule of product administration 241.25 21.38 147 7950 45678 32459751
Nausea 229.17 21.38 335 7762 320514 32184915
Pancreatitis 212.64 21.38 127 7970 38024 32467405
Glycosylated haemoglobin increased 194.04 21.38 79 8018 10310 32495119
Diabetic ketoacidosis 185.22 21.38 90 8007 17842 32487587
Extra dose administered 142.72 21.38 47 8050 3356 32502073
Diarrhoea 135.23 21.38 286 7811 364516 32140913
Vomiting 119.21 21.38 211 7886 235346 32270083
Diabetes mellitus inadequate control 115.36 21.38 60 8037 13708 32491721
Injection site mass 110.14 21.38 44 8053 5457 32499972
Pancreatitis acute 109.66 21.38 74 8023 27261 32478168
Accidental overdose 98.89 21.38 61 8036 19278 32486151
Incorrect dose administered 93.21 21.38 74 8023 34954 32470475
Injection site erythema 92.57 21.38 53 8044 14615 32490814
Injection site haemorrhage 85.57 21.38 42 8055 8486 32496943
Euglycaemic diabetic ketoacidosis 83.62 21.38 30 8067 2768 32502661
Injection site pruritus 82.79 21.38 37 8060 6053 32499376
Product dose omission issue 82.55 21.38 114 7983 102461 32402968
Obstructive pancreatitis 67.73 21.38 17 8080 454 32504975
Underdose 63.69 21.38 40 8057 13029 32492400
Weight decreased 56.82 21.38 126 7971 164692 32340737
Eructation 56.52 21.38 25 8072 3988 32501441
Ketoacidosis 55.64 21.38 25 8072 4139 32501290
Injection site swelling 53.51 21.38 32 8065 9552 32495877
Lactic acidosis 49.74 21.38 51 8046 33485 32471944
Pancreatic carcinoma 49.69 21.38 29 8068 8277 32497152
Lipase increased 46.78 21.38 29 8068 9228 32496201
Injection site rash 36.35 21.38 18 8079 3702 32501727
Injury associated with device 36.34 21.38 12 8085 862 32504567
Injection site bruising 35.76 21.38 23 8074 7797 32497632
Injection site discomfort 35.58 21.38 13 8084 1263 32504166
Hypoglycaemia 32.95 21.38 53 8044 54329 32451100
Pancreatic carcinoma metastatic 32.21 21.38 16 8081 3313 32502116
Blood glucose abnormal 32.08 21.38 19 8078 5569 32499860
Injection site reaction 31.93 21.38 25 8072 11544 32493885
Abdominal discomfort 31.49 21.38 51 8046 52573 32452856
Hyperkinetic heart syndrome 30.56 21.38 7 8090 125 32505304
Blood glucose decreased 30.52 21.38 26 8071 13508 32491921
Abdominal pain 30.48 21.38 94 8003 149435 32355994
Dyspepsia 29.96 21.38 39 8058 33016 32472413
Glycosylated haemoglobin abnormal 29.31 21.38 7 8090 151 32505278
Injection site urticaria 28.99 21.38 12 8085 1627 32503802
Hyperlipasaemia 28.70 21.38 9 8088 548 32504881
Acute kidney injury 28.45 21.38 146 7951 293322 32212107
Gastric dilatation 28.22 21.38 9 8088 579 32504850
Wrong drug 27.77 21.38 6 8091 81 32505348
Ketonuria 27.30 21.38 9 8088 643 32504786
Pneumonia 26.24 21.38 30 8067 355222 32150207
Injection site nodule 26.22 21.38 11 8086 1542 32503887
Flatulence 26.12 21.38 28 8069 19327 32486102
Gastrointestinal disorder 25.73 21.38 35 8062 30896 32474533
Product storage error 25.38 21.38 18 8079 7160 32498269
Abdominal pain upper 22.57 21.38 51 8046 67287 32438142
Product administration error 21.78 21.38 23 8074 15602 32489827

Pharmacologic Action:

SourceCodeDescription
ATC A10BJ05 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Glucagon-like peptide-1 (GLP-1) analogues
FDA CS M0160181 Glucagon-Like Peptide 1
FDA MoA N0000020058 Glucagon-like Peptide-1 (GLP-1) Agonists
MeSH PA D007004 Hypoglycemic Agents
FDA EPC N0000178480 GLP-1 Receptor Agonist

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Diabetes mellitus type 2 indication 44054006 DOID:9352

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glucagon-like peptide 1 receptor GPCR AGONIST DRUG LABEL DRUG LABEL

External reference:

IDSource
WTT295HSY5 UNII
D09889 KEGG_DRUG
4033739 VUID
N0000191089 NUI
4033739 VANDF
C3179549 UMLSCUI
CHEMBL2108027 ChEMBL_ID
DB09045 DRUGBANK_ID
C555680 MESH_SUPPLEMENTAL_RECORD_UI
7638 IUPHAR_LIGAND_ID
9164 INN_ID
1551291 RXNORM
228834 MMSL
30573 MMSL
d08290 MMSL
015693 NDDF
714080005 SNOMEDCT_US
714081009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Trulicity HUMAN PRESCRIPTION DRUG LABEL 1 0002-1433 INJECTION, SOLUTION 0.75 mg SUBCUTANEOUS BLA 36 sections
Trulicity HUMAN PRESCRIPTION DRUG LABEL 1 0002-1434 INJECTION, SOLUTION 1.50 mg SUBCUTANEOUS BLA 36 sections
Trulicity HUMAN PRESCRIPTION DRUG LABEL 1 0002-2236 INJECTION, SOLUTION 3 mg SUBCUTANEOUS BLA 36 sections
Trulicity HUMAN PRESCRIPTION DRUG LABEL 1 0002-3182 INJECTION, SOLUTION 4.50 mg SUBCUTANEOUS BLA 36 sections
Trulicity HUMAN PRESCRIPTION DRUG LABEL 1 50090-3483 INJECTION, SOLUTION 1.50 mg SUBCUTANEOUS BLA 35 sections
Trulicity HUMAN PRESCRIPTION DRUG LABEL 1 50090-3484 INJECTION, SOLUTION 0.75 mg SUBCUTANEOUS BLA 35 sections
Trulicity HUMAN PRESCRIPTION DRUG LABEL 1 50090-5467 INJECTION, SOLUTION 3 mg SUBCUTANEOUS BLA 35 sections