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

Stem definitionDrug idCAS RN
4960 844439-96-9

Description:

MoleculeDescription

Synonyms:

  • insulin degludec
  • tresiba
  • NN1250
insulin degludec is a long-acting basal human insulin analog for subcutaneous injection, differs from human insulin in that the amino acid threonine in position B30 has been omitted and a side-chain consisting of glutamic acid and a C16 fatty acid has been attached
  • Molecular weight: 6104.04
  • Formula: C274H411N65O81S6
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA: 2356.52
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
40 U P
40 U P
40 U P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 21, 2013 EMA
Sept. 25, 2015 FDA NOVO NORDISK INC
Sept. 28, 2012 PMDA Novo Nordisk Pharma Ltd

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
Hypoglycaemia 784.10 17.09 304 9069 59761 63419888
Diabetic ketoacidosis 374.03 17.09 133 9240 20372 63459277
Blood glucose increased 343.17 17.09 190 9183 83566 63396083
Blood glucose decreased 186.90 17.09 81 9292 20871 63458778
Diabetes mellitus inadequate control 123.60 17.09 55 9318 15071 63464578
Blood glucose fluctuation 115.88 17.09 38 9335 4538 63475111
Diabetic neuropathy 112.95 17.09 36 9337 3928 63475721
Hyperglycaemia 106.29 17.09 70 9303 41797 63437852
Heart sounds 93.38 17.09 23 9350 973 63478676
Prolonged expiration 91.20 17.09 23 9350 1073 63478576
Sleep disorder due to a general medical condition 89.05 17.09 41 9332 12147 63467502
Hypoglycaemic coma 88.52 17.09 27 9346 2548 63477101
Glycosylated haemoglobin increased 82.21 17.09 39 9334 12359 63467290
Impaired gastric emptying 70.03 17.09 33 9340 10299 63469350
Hypoglycaemic unconsciousness 68.11 17.09 17 9356 760 63478889
Depressive symptom 64.95 17.09 24 9349 4078 63475571
Appetite disorder 57.80 17.09 26 9347 7295 63472354
Diabetic retinopathy 57.61 17.09 19 9354 2308 63477341
Blood glucose abnormal 55.94 17.09 26 9347 7866 63471783
Respiration abnormal 54.55 17.09 24 9349 6393 63473256
Rales 44.28 17.09 26 9347 12671 63466978
Ketoacidosis 42.55 17.09 18 9355 4360 63475289
Joint abscess 41.09 17.09 10 9363 402 63479247
Neuropathy peripheral 35.92 17.09 62 9311 113605 63366044
Hypoglycaemia unawareness 34.76 17.09 7 9366 115 63479534
Diabetes mellitus 34.71 17.09 42 9331 55768 63423881
Stress 34.57 17.09 46 9327 67121 63412528
Intentional overdose 33.97 17.09 48 9325 74104 63405545
Fear-related avoidance of activities 33.95 17.09 7 9366 130 63479519
Hypoglycaemic encephalopathy 33.31 17.09 8 9365 304 63479345
Suicide attempt 31.78 17.09 42 9331 60876 63418773
Flank pain 31.21 17.09 23 9350 16387 63463262
Device failure 31.17 17.09 16 9357 5995 63473654
Retinopathy 30.90 17.09 13 9360 3106 63476543
Angina pectoris 29.89 17.09 29 9344 30049 63449600
Hypoglycaemic seizure 29.69 17.09 8 9365 484 63479165
Carcinoid crisis 29.32 17.09 7 9366 259 63479390
Acute painful neuropathy of rapid glycaemic control 29.05 17.09 4 9369 3 63479646
Ketosis 27.95 17.09 8 9365 605 63479044
Taste disorder 27.92 17.09 20 9353 13642 63466007
Drug intolerance 27.49 17.09 6 9367 308655 63170994
Wheezing 27.43 17.09 50 9323 95545 63384104
Toxicity to various agents 26.07 17.09 3 9370 247247 63232402
Infusion related reaction 25.83 17.09 3 9370 245518 63234131
Asthma 23.93 17.09 56 9317 127505 63352144
Thirst decreased 23.83 17.09 6 9367 278 63479371
Hospitalisation 23.77 17.09 44 9329 85037 63394612
Diabetic metabolic decompensation 23.42 17.09 9 9364 1701 63477948
Muscle necrosis 22.94 17.09 7 9366 661 63478988
Arthropathy 22.08 17.09 4 9369 234788 63244861
Retinal degeneration 20.97 17.09 7 9366 882 63478767
Presbyopia 20.82 17.09 6 9367 465 63479184
Metabolic acidosis 20.37 17.09 29 9344 45040 63434609
Hypoglycaemia neonatal 20.34 17.09 7 9366 968 63478681
Product prescribing error 20.07 17.09 22 9351 26267 63453382
Depressed mood 19.87 17.09 27 9346 40164 63439485
Infective myositis 19.85 17.09 4 9369 66 63479583
Contraindicated product administered 19.84 17.09 4 9369 217644 63262005
Reperfusion arrhythmia 19.70 17.09 5 9368 239 63479410
Dyspnoea exertional 19.17 17.09 33 9340 60269 63419380
Nasal congestion 18.39 17.09 34 9339 65626 63414023
Intestinal ulcer 17.81 17.09 7 9366 1404 63478245
Drug ineffective 17.67 17.09 87 9286 1044678 62434971
Loss of personal independence in daily activities 17.47 17.09 42 9331 97248 63382401
Treatment failure 17.44 17.09 4 9369 199039 63280610
Haemorrhagic disorder 17.29 17.09 6 9367 850 63478799
Erysipelas 17.14 17.09 12 9361 7893 63471756

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
Hypoglycaemia 475.22 20.47 253 9527 54387 34892764
Appendicolith 452.75 20.47 145 9635 8456 34938695
Appendicitis 375.70 20.47 145 9635 14662 34932489
Cardiogenic shock 327.14 20.47 156 9624 26462 34920689
Stress 287.39 20.47 149 9631 30198 34916953
Ascites 252.90 20.47 159 9621 46412 34900739
Abdominal distension 215.38 20.47 157 9623 58335 34888816
Ventricular fibrillation 203.77 20.47 108 9672 22846 34924305
Blood glucose increased 188.47 20.47 153 9627 66565 34880586
Blood phosphorus increased 182.88 20.47 72 9708 7649 34939502
Multiple organ dysfunction syndrome 170.12 20.47 153 9627 76413 34870738
Diabetic ketoacidosis 160.44 20.47 85 9695 17947 34929204
Hyponatraemia 156.24 20.47 151 9629 82540 34864611
General physical health deterioration 140.76 20.47 176 9604 128093 34819058
Blood glucose decreased 133.81 20.47 68 9712 13169 34933982
Constipation 116.51 20.47 166 9614 136816 34810335
Dry mouth 106.38 20.47 79 9701 30086 34917065
Abdominal pain 106.32 20.47 175 9605 163443 34783708
Sepsis 105.35 20.47 176 9604 166385 34780766
Diabetes mellitus inadequate control 91.03 20.47 53 9727 13411 34933740
Vomiting 87.63 20.47 205 9575 247416 34699735
Hypoglycaemic unconsciousness 83.85 20.47 23 9757 775 34946376
Nausea 79.31 20.47 241 9539 339667 34607484
Myasthenia gravis 77.02 20.47 38 9742 6902 34940249
Impaired gastric emptying 74.08 20.47 30 9750 3423 34943728
Blood uric acid increased 70.70 20.47 40 9740 9584 34937567
Glycosylated haemoglobin increased 45.12 20.47 32 9748 11328 34935823
Somnolence 44.69 20.47 97 9683 111019 34836132
Hyperglycaemia 44.44 20.47 55 9725 39425 34907726
Blood cholesterol increased 43.41 20.47 40 9740 20503 34926648
Drug therapy 43.08 20.47 15 9765 1126 34946025
Incorrect route of product administration 41.68 20.47 34 9746 14811 34932340
Analgesic therapy 41.10 20.47 14 9766 984 34946167
Sleep disorder therapy 36.90 20.47 13 9767 1010 34946141
Hyperphosphataemia 36.85 20.47 20 9760 4417 34942734
Hypoglycaemic seizure 36.80 20.47 10 9770 325 34946826
Hypoglycaemia unawareness 34.21 20.47 8 9772 139 34947012
Hypoglycaemic coma 32.09 20.47 15 9765 2416 34944735
Iron deficiency 30.69 20.47 19 9761 5362 34941789
Blood glucose fluctuation 27.53 20.47 16 9764 4028 34943123
Dysmetria 26.83 20.47 9 9771 603 34946548
Bacterial infection 26.34 20.47 28 9752 17035 34930116
Oedematous pancreatitis 24.56 20.47 8 9772 489 34946662
Neuralgia 23.68 20.47 25 9755 15088 34932063
Diabetic metabolic decompensation 23.63 20.47 11 9769 1755 34945396
Condition aggravated 23.39 20.47 111 9669 192085 34755066
Euglycaemic diabetic ketoacidosis 22.60 20.47 13 9767 3209 34943942
Gait spastic 21.73 20.47 9 9771 1087 34946064
Neuropathy peripheral 21.09 20.47 61 9719 83202 34863949

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
Hypoglycaemia 936.75 15.94 448 16532 101146 79626262
Appendicolith 487.78 15.94 144 16836 8407 79719001
Diabetic ketoacidosis 431.85 15.94 188 16792 33934 79693474
Appendicitis 365.90 15.94 145 16835 20649 79706759
Blood glucose increased 354.54 15.94 249 16731 114726 79612682
Cardiogenic shock 299.88 15.94 156 16824 41758 79685650
Stress 291.87 15.94 192 16788 79420 79647988
Ascites 226.53 15.94 161 16819 75401 79652007
Ventricular fibrillation 197.77 15.94 108 16872 31818 79695590
Abdominal distension 186.43 15.94 174 16806 119476 79607932
Diabetes mellitus inadequate control 184.10 15.94 94 16886 24170 79703238
Blood phosphorus increased 181.39 15.94 72 16908 10275 79717133
Blood glucose decreased 154.91 15.94 86 16894 26148 79701260
Multiple organ dysfunction syndrome 148.40 15.94 154 16826 120092 79607316
Impaired gastric emptying 140.53 15.94 60 16920 10293 79717115
Hyperglycaemia 124.58 15.94 110 16870 70225 79657183
Diabetic neuropathy 118.60 15.94 46 16934 6170 79721238
Hypoglycaemic unconsciousness 118.47 15.94 31 16949 1152 79726256
Hyponatraemia 116.20 15.94 165 16815 177683 79549725
Blood glucose fluctuation 111.91 15.94 45 16935 6637 79720771
Hypoglycaemic coma 104.41 15.94 39 16941 4721 79722687
Sepsis 95.42 15.94 190 16790 269238 79458170
Constipation 92.42 15.94 193 16787 282857 79444551
General physical health deterioration 90.24 15.94 188 16792 275050 79452358
Glycosylated haemoglobin increased 86.80 15.94 53 16927 19207 79708201
Heart sounds 85.71 15.94 23 16957 943 79726465
Prolonged expiration 79.46 15.94 23 16957 1248 79726160
Dry mouth 73.28 15.94 92 16888 87927 79639481
Myasthenia gravis 72.27 15.94 38 16942 10361 79717047
Sleep disorder due to a general medical condition 71.37 15.94 42 16938 14235 79713173
Toxicity to various agents 70.53 15.94 5 16975 421535 79305873
Blood uric acid increased 68.62 15.94 40 16940 13320 79714088
Abdominal pain 65.70 15.94 207 16773 389362 79338046
Hypoglycaemia unawareness 64.76 15.94 14 16966 224 79727184
Neuropathy peripheral 62.88 15.94 110 16870 141195 79586213
Ketoacidosis 55.43 15.94 29 16951 7825 79719583
Hypoglycaemic seizure 51.91 15.94 15 16965 809 79726599
Hypoglycaemic encephalopathy 50.54 15.94 14 16966 647 79726761
Appetite disorder 50.17 15.94 27 16953 7712 79719696
Diabetic retinopathy 48.86 15.94 20 16960 3086 79724322
Diabetic metabolic decompensation 47.50 15.94 20 16960 3312 79724096
Drug therapy 46.34 15.94 15 16965 1186 79726222
Vomiting 46.19 15.94 270 16710 665558 79061850
Nausea 45.37 15.94 353 16627 956843 78770565
Analgesic therapy 44.70 15.94 14 16966 995 79726413
Depressive symptom 43.30 15.94 23 16957 6400 79721008
Blood glucose abnormal 42.36 15.94 27 16953 10539 79716869
Respiration abnormal 41.81 15.94 24 16956 7764 79719644
Sleep disorder therapy 40.37 15.94 13 16967 1011 79726397
Hyperphosphataemia 37.88 15.94 21 16959 6355 79721053
Euglycaemic diabetic ketoacidosis 36.50 15.94 21 16959 6823 79720585
Joint abscess 34.74 15.94 10 16970 532 79726876
Fear-related avoidance of activities 32.99 15.94 7 16973 102 79727306
Rales 32.85 15.94 30 16950 19971 79707437
Suicide attempt 31.10 15.94 60 16920 82872 79644536
Drug ineffective 29.18 15.94 125 16855 1080788 78646620
Incorrect route of product administration 28.23 15.94 36 16944 34893 79692515
Acute painful neuropathy of rapid glycaemic control 27.58 15.94 4 16976 3 79727405
Intentional overdose 27.46 15.94 66 16914 105894 79621514
Somnolence 27.35 15.94 112 16868 238869 79488539
Oedematous pancreatitis 27.19 15.94 10 16970 1158 79726250
Arthropathy 27.15 15.94 3 16977 177108 79550300
Infusion related reaction 26.57 15.94 8 16972 230229 79497179
Iron deficiency 25.81 15.94 20 16960 10634 79716774
Therapeutic product effect decreased 24.56 15.94 3 16977 163860 79563548
Drug abuse 24.33 15.94 3 16977 162688 79564720
Joint swelling 23.99 15.94 16 16964 288630 79438778
Retinopathy 23.62 15.94 13 16967 3878 79723530
Pancreatic carcinoma 23.54 15.94 21 16959 13556 79713852
Treatment failure 23.51 15.94 4 16976 170482 79556926
Diabetic foot infection 22.90 15.94 8 16972 799 79726609
Carcinoid crisis 22.10 15.94 7 16973 516 79726892
Flank pain 21.92 15.94 24 16956 19820 79707588
Diabetic foot 21.68 15.94 12 16968 3620 79723788
Thirst decreased 21.07 15.94 6 16974 307 79727101
Tachycardia 20.83 15.94 6 16974 177762 79549646
Incorrect dose administered by device 20.63 15.94 13 16967 4976 79722432
Synovitis 19.79 15.94 4 16976 150730 79576678
Taste disorder 19.00 15.94 20 16960 15803 79711605
Sinusitis 18.88 15.94 9 16971 195492 79531916
Disease progression 18.56 15.94 8 16972 184354 79543054
Neutropenia 17.83 15.94 21 16959 287689 79439719
Bacterial infection 17.46 15.94 27 16953 31253 79696155
Arthralgia 17.35 15.94 63 16917 571740 79155668
Presbyopia 17.25 15.94 6 16974 592 79726816
Cerebral infarction 17.06 15.94 33 16947 45643 79681765
Reperfusion arrhythmia 16.87 15.94 5 16975 295 79727113
Ketosis 16.86 15.94 7 16973 1119 79726289
Thrombocytopenia 16.82 15.94 19 16961 265240 79462168
Hypotension 16.54 15.94 44 16936 440273 79287135
Urogenital infection fungal 16.39 15.94 3 16977 19 79727389
Diabetes mellitus 16.34 15.94 45 16935 78345 79649063

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A10AD06 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
INSULINS AND ANALOGUES
Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting
ATC A10AE06 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
INSULINS AND ANALOGUES
Insulins and analogues for injection, long-acting
ATC A10AE56 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
INSULINS AND ANALOGUES
Insulins and analogues for injection, long-acting
FDA CS M0011417 Insulin
FDA EPC N0000175453 Insulin Analog
CHEBI has role CHEBI:35526 antidiabetic
FDA EPC N0000175944 Insulin

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Diabetes mellitus indication 73211009 DOID:9351




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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
Insulin receptor Kinase AGONIST DRUG LABEL DRUG LABEL

External reference:

IDSource
D09727 KEGG_DRUG
4017559 VANDF
4017569 VANDF
4019786 VANDF
4035011 VANDF
CHEBI:5931 CHEBI
CHEMBL2107869 ChEMBL_ID
C571886 MESH_SUPPLEMENTAL_RECORD_UI
DB09564 DRUGBANK_ID
DB00030 DRUGBANK_ID
1670007 RXNORM
236826 MMSL
29260 MMSL
361472 MMSL
366445 MMSL
4885 MMSL
4886 MMSL
d00262 MMSL
d04369 MMSL
d08054 MMSL
000869 NDDF
000870 NDDF
006518 NDDF
015340 NDDF
126210001 SNOMEDCT_US
417423002 SNOMEDCT_US
420609005 SNOMEDCT_US
710281005 SNOMEDCT_US
715774000 SNOMEDCT_US
96367001 SNOMEDCT_US
C3491971 UMLSCUI
C0795635 UMLSCUI
9170 INN_ID
118984462 PUBCHEM_CID
5186 INN_ID
118984375 PUBCHEM_CID
54Q18076QB UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Tresiba HUMAN PRESCRIPTION DRUG LABEL 1 0169-2550 INJECTION, SOLUTION 200 U SUBCUTANEOUS BLA 28 sections
Tresiba HUMAN PRESCRIPTION DRUG LABEL 1 0169-2550 INJECTION, SOLUTION 200 U SUBCUTANEOUS BLA 28 sections
Tresiba HUMAN PRESCRIPTION DRUG LABEL 1 0169-2660 INJECTION, SOLUTION 100 U SUBCUTANEOUS BLA 28 sections
Tresiba HUMAN PRESCRIPTION DRUG LABEL 1 0169-2660 INJECTION, SOLUTION 100 U SUBCUTANEOUS BLA 28 sections
Tresiba HUMAN PRESCRIPTION DRUG LABEL 1 0169-2662 INJECTION, SOLUTION 100 U SUBCUTANEOUS BLA 28 sections
Tresiba HUMAN PRESCRIPTION DRUG LABEL 1 0169-2662 INJECTION, SOLUTION 100 U SUBCUTANEOUS BLA 28 sections
Xultophy 100/3.6 HUMAN PRESCRIPTION DRUG LABEL 2 0169-2911 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Xultophy 100/3.6 HUMAN PRESCRIPTION DRUG LABEL 2 0169-2911 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Xultophy 100/3.6 HUMAN PRESCRIPTION DRUG LABEL 2 0169-2911 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Tresiba HUMAN PRESCRIPTION DRUG LABEL 1 50090-3491 INJECTION, SOLUTION 200 U SUBCUTANEOUS BLA 28 sections
Tresiba HUMAN PRESCRIPTION DRUG LABEL 1 50090-3491 INJECTION, SOLUTION 200 U SUBCUTANEOUS BLA 28 sections
Insulin Degludec HUMAN PRESCRIPTION DRUG LABEL 1 73070-400 INJECTION, SOLUTION 100 U SUBCUTANEOUS BLA 27 sections
Insulin Degludec HUMAN PRESCRIPTION DRUG LABEL 1 73070-403 INJECTION, SOLUTION 100 U SUBCUTANEOUS BLA 27 sections
Insulin Degludec HUMAN PRESCRIPTION DRUG LABEL 1 73070-503 INJECTION, SOLUTION 200 U SUBCUTANEOUS BLA 27 sections