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

Stem definitionDrug idCAS RN
peptides and glycopeptides 1546 108736-35-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • lanreotide
  • angiopeptin
  • ipstyl
  • lanreotide autogel
  • somatulin-autogel
  • somatuline
  • lanreotide acetate
synthetic octapeptide analog of somatostatin; inhibits accelerated transplant atherosclerosis in rabbit heart arteries
  • Molecular weight: 1096.33
  • Formula: C54H69N11O10S2
  • CLOGP: 3.42
  • LIPINSKI: 3
  • HAC: 21
  • HDO: 13
  • TPSA: 355.08
  • ALOGS: -5.34
  • ROTB: 17

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
3 mg P

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 0.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.70 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.03 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 30, 2007 FDA IPSEN PHARMA
Dec. 12, 2020 PMDA TEIJIN PHARMA LIMITED

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
Inappropriate schedule of product administration 267.59 18.94 178 9629 103787 63375428
Injection site mass 219.55 18.94 89 9718 18567 63460648
Insulin-like growth factor increased 208.64 18.94 44 9763 875 63478340
Diarrhoea 174.12 18.94 356 9451 715010 62764205
Injection site pain 137.46 18.94 132 9675 129668 63349547
Abdominal pain 104.87 18.94 173 9634 293283 63185932
Cholelithiasis 102.70 18.94 71 9736 43854 63435361
Flatulence 90.43 18.94 60 9747 34642 63444573
Abdominal distension 89.54 18.94 87 9720 86528 63392687
Blood growth hormone increased 86.87 18.94 19 9788 451 63478764
Neoplasm progression 76.14 18.94 55 9752 36373 63442842
Off label use 70.58 18.94 246 9561 674216 62804999
Carcinoid tumour pulmonary 64.80 18.94 15 9792 463 63478752
Disease progression 64.74 18.94 87 9720 122671 63356544
Injection site nodule 58.14 18.94 22 9785 3813 63475402
Intestinal obstruction 47.76 18.94 39 9768 30860 63448355
Terminal state 45.41 18.94 16 9791 2266 63476949
Carcinoid crisis 44.99 18.94 10 9797 256 63478959
Needle issue 42.58 18.94 24 9783 10352 63468863
Blood glucose increased 40.56 18.94 57 9750 83699 63395516
Menopausal symptoms 40.52 18.94 15 9792 2446 63476769
Carcinoid syndrome 39.92 18.94 8 9799 122 63479093
Bronchiolitis 38.92 18.94 15 9792 2732 63476483
Weight decreased 38.86 18.94 112 9695 276686 63202529
Abdominal pain upper 38.62 18.94 93 9714 206351 63272864
Hypoglycaemia 38.61 18.94 47 9760 60018 63419197
Nausea 37.32 18.94 242 9565 854229 62624986
Product dose omission issue 37.01 18.94 99 9708 234214 63245001
Asthenia 36.55 18.94 136 9671 383468 63095747
Blood glucose decreased 35.68 18.94 28 9779 20924 63458291
Steatorrhoea 33.92 18.94 9 9798 490 63478725
Flushing 33.28 18.94 49 9758 75038 63404177
Death 32.59 18.94 129 9678 374252 63104963
Insulin-like growth factor abnormal 31.25 18.94 5 9802 18 63479197
Incorrect route of product administration 31.03 18.94 29 9778 27423 63451792
Insulinoma 30.62 18.94 6 9801 81 63479134
Faeces pale 30.25 18.94 11 9796 1706 63477509
Injection site pruritus 30.13 18.94 36 9771 45080 63434135
Hepatic neoplasm 28.96 18.94 11 9796 1925 63477290
Rheumatoid arthritis 28.56 18.94 3 9804 253816 63225399
Blood chromogranin A increased 28.29 18.94 7 9800 288 63478927
Constipation 27.74 18.94 87 9720 224856 63254359
Drug hypersensitivity 27.60 18.94 7 9800 310680 63168535
Malaise 27.53 18.94 132 9675 415822 63063393
Malignant neoplasm progression 27.30 18.94 47 9760 82074 63397141
Product administered at inappropriate site 26.96 18.94 12 9795 3137 63476078
Decreased appetite 26.40 18.94 92 9715 250960 63228255
Vomiting 25.86 18.94 161 9646 559456 62919759
Arthropathy 25.85 18.94 3 9804 234789 63244426
Toxicity to various agents 25.23 18.94 4 9803 247246 63231969
Pituitary tumour removal 24.87 18.94 4 9803 15 63479200
Metastases to liver 24.86 18.94 24 9783 23615 63455600
Injection site haemorrhage 24.29 18.94 24 9783 24290 63454925
Rash 23.94 18.94 31 9776 560840 62918375
Gastroenteropancreatic neuroendocrine tumour disease 22.43 18.94 4 9803 31 63479184
Postoperative adhesion 21.89 18.94 6 9801 370 63478845
Muscle neoplasm 21.80 18.94 4 9803 37 63479178
Gallbladder neoplasm 21.61 18.94 4 9803 39 63479176
Lymphatic system neoplasm 21.26 18.94 4 9803 43 63479172
Thyroid neoplasm 21.25 18.94 11 9796 4008 63475207
Biliary dilatation 20.57 18.94 9 9798 2260 63476955
Injection site hypoaesthesia 20.23 18.94 6 9801 491 63478724
Hypersensitivity 20.19 18.94 10 9797 292675 63186540
Hospitalisation 19.98 18.94 42 9765 85039 63394176
Neoplasm 19.85 18.94 13 9794 7332 63471883
Body height increased 19.55 18.94 4 9803 68 63479147
Spleen disorder 19.50 18.94 7 9800 1046 63478169
Gastrointestinal hypomotility 19.32 18.94 7 9800 1074 63478141
Drug intolerance 19.19 18.94 12 9795 308649 63170566

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
Inappropriate schedule of product administration 191.42 23.30 126 6148 62170 34888487
Diarrhoea 167.80 23.30 270 6004 389642 34561015
Injection site pain 152.55 23.30 92 6182 38913 34911744
Insulin-like growth factor increased 132.20 23.30 33 6241 1210 34949447
Neoplasm progression 131.77 23.30 70 6204 23230 34927427
Injection site mass 98.42 23.30 39 6235 6587 34944070
Abdominal pain 87.63 23.30 126 6148 163492 34787165
Off label use 87.46 23.30 215 6059 419309 34531348
Disease progression 87.25 23.30 102 6172 107975 34842682
Flatulence 82.77 23.30 50 6224 21148 34929509
Injection site haemorrhage 71.63 23.30 35 6239 9733 34940924
Cholelithiasis 70.21 23.30 45 6229 21103 34929554
Carcinoid heart disease 67.94 23.30 10 6264 13 34950644
Pituitary tumour benign 48.94 23.30 14 6260 867 34949790
Incorrect route of product administration 47.80 23.30 31 6243 14814 34935843
Growth hormone deficiency 47.80 23.30 11 6263 283 34950374
Carcinoid crisis 38.59 23.30 9 6265 246 34950411
Pituitary tumour removal 38.13 23.30 5 6269 0 34950657
Death 37.85 23.30 156 6118 397893 34552764
Metastases to liver 35.54 23.30 25 6249 13638 34937019
Pancreatic neuroendocrine tumour metastatic 34.65 23.30 7 6267 95 34950562
Injection site nodule 32.50 23.30 12 6262 1671 34948986
Abdominal pain upper 32.33 23.30 51 6223 71439 34879218
Injection site abscess 32 23.30 10 6264 839 34949818
Terminal state 31.56 23.30 15 6259 3919 34946738
Insulin-like growth factor abnormal 31.46 23.30 5 6269 14 34950643
Steatorrhoea 29.05 23.30 9 6265 734 34949923
Product dose omission issue 27.49 23.30 64 6210 119647 34831010
Hepatic neoplasm 27.14 23.30 11 6263 1966 34948691
Hepatic pain 26.64 23.30 10 6264 1458 34949199
Acromegaly 26.43 23.30 5 6269 47 34950610
Asthenia 25.50 23.30 99 6175 245152 34705505
Abdominal distension 25.43 23.30 41 6233 58451 34892206
Drug interaction 25.19 23.30 5 6269 225941 34724716
Flushing 25.07 23.30 30 6244 32390 34918267
Abdominal discomfort 24.74 23.30 41 6233 59794 34890863
Malignant neoplasm progression 24.66 23.30 51 6223 87995 34862662
Bile duct stone 24.33 23.30 11 6263 2566 34948091

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
Inappropriate schedule of product administration 285.18 19.07 213 13530 133415 79597230
Diarrhoea 257.35 19.07 504 13239 879985 78850660
Insulin-like growth factor increased 243.14 19.07 58 13685 1828 79728817
Injection site pain 208.17 19.07 175 13568 129663 79600982
Injection site mass 196.81 19.07 87 13656 20097 79710548
Abdominal pain 174.40 19.07 270 13473 389299 79341346
Flatulence 163.34 19.07 98 13645 42626 79688019
Neoplasm progression 158.37 19.07 103 13640 51579 79679066
Cholelithiasis 132.74 19.07 93 13650 52571 79678074
Off label use 102.41 19.07 365 13378 906850 78823795
Abdominal distension 100.16 19.07 113 13630 119537 79611108
Disease progression 96.86 19.07 138 13605 184224 79546421
Injection site nodule 66.86 19.07 25 13718 3755 79726890
Carcinoid tumour pulmonary 66.43 19.07 15 13728 369 79730276
Intestinal obstruction 62.72 19.07 55 13688 42965 79687680
Insulin-like growth factor abnormal 61.41 19.07 10 13733 36 79730609
Terminal state 60.62 19.07 25 13718 4864 79725781
Toxicity to various agents 60.26 19.07 3 13740 421537 79309108
Asthenia 59.20 19.07 208 13535 511481 79219164
Injection site haemorrhage 58.32 19.07 44 13699 27826 79702819
Carcinoid heart disease 57.51 19.07 10 13733 58 79730587
Weight decreased 57.25 19.07 162 13581 355036 79375609
Carcinoid crisis 56.74 19.07 14 13729 509 79730136
Blood growth hormone increased 56.73 19.07 15 13728 721 79729924
Metastases to liver 55.51 19.07 43 13700 28271 79702374
Abdominal pain upper 52.74 19.07 118 13625 223701 79506944
Malignant neoplasm progression 52.02 19.07 88 13655 135902 79594743
Pituitary tumour removal 51.60 19.07 8 13735 19 79730626
Product dose omission issue 50.14 19.07 123 13620 247414 79483231
Flushing 49.14 19.07 68 13675 88200 79642445
Pituitary tumour benign 49.10 19.07 18 13725 2558 79728087
Growth hormone deficiency 49.10 19.07 12 13731 419 79730226
Steatorrhoea 48.88 19.07 14 13729 907 79729738
Nausea 48.77 19.07 306 13437 956890 78773755
Incorrect route of product administration 47.62 19.07 43 13700 34886 79695759
Hepatic neoplasm 47.56 19.07 19 13724 3407 79727238
Blood glucose increased 46.10 19.07 76 13667 114899 79615746
Injection site abscess 44.87 19.07 15 13728 1625 79729020
Death 44.38 19.07 204 13539 566310 79164335
Blood chromogranin A increased 42.39 19.07 11 13732 491 79730154
Menopausal symptoms 42.22 19.07 15 13728 1948 79728697
Needle issue 39.88 19.07 26 13717 13042 79717603
Vomiting 39.68 19.07 222 13521 665606 79065039
Insulinoma 38.93 19.07 8 13735 124 79730521
Drug hypersensitivity 37.38 19.07 4 13739 298912 79431733
Blood glucose decreased 37.15 19.07 33 13710 26201 79704444
Drug interaction 36.51 19.07 13 13730 415170 79315475
Faeces pale 36.28 19.07 15 13728 2935 79727710
Hypoglycaemia 35.25 19.07 63 13680 101531 79629114
Carcinoid syndrome 35.23 19.07 8 13735 202 79730443
Hepatic pain 34.74 19.07 16 13727 4056 79726589
Acromegaly 34.40 19.07 7 13736 103 79730542
Constipation 32.57 19.07 115 13628 282935 79447710
Rash 31.48 19.07 32 13711 578326 79152319
Bronchiolitis 31.24 19.07 15 13728 4173 79726472
Metastases to bone 29.29 19.07 28 13715 24399 79706246
Pituitary tumour 28.82 19.07 10 13733 1212 79729433
Bile duct stone 27.15 19.07 15 13728 5574 79725071
Biliary obstruction 26.79 19.07 14 13729 4660 79725985
Pneumonia 26.29 19.07 46 13697 660200 79070445
Decreased appetite 25.76 19.07 122 13621 342296 79388349
Injection site pruritus 25.68 19.07 34 13709 42249 79688396
Malaise 25.65 19.07 158 13585 489711 79240934
Thyroid neoplasm 25.65 19.07 12 13731 3152 79727493
Neoplasm 25.07 19.07 17 13726 9099 79721546
Tumour necrosis 24.41 19.07 10 13733 1912 79728733
Injection site induration 23.92 19.07 17 13726 9802 79720843
Gallbladder neoplasm 23.84 19.07 5 13738 86 79730559
Injection site hypoaesthesia 23.29 19.07 7 13736 537 79730108
Palliative care 23.08 19.07 8 13735 967 79729678
Hepatic embolisation 22.89 19.07 4 13739 24 79730621
Injection site discomfort 22.75 19.07 13 13730 5153 79725492
Acute kidney injury 22.71 19.07 34 13709 519370 79211275
Febrile neutropenia 22.50 19.07 6 13737 230993 79499652
Headache 21.13 19.07 188 13555 653584 79077061
Hepatobiliary disease 20.79 19.07 7 13736 775 79729870
Gastroenteropancreatic neuroendocrine tumour disease 20.73 19.07 4 13739 44 79730601
Hormone level abnormal 20.70 19.07 9 13734 1993 79728652
Arthropathy 20.59 19.07 3 13740 177108 79553537
Fatigue 20.41 19.07 247 13496 929480 78801165
Injection site scar 20.35 19.07 7 13736 826 79729819
Biliary colic 20.26 19.07 11 13732 3951 79726694
Muscle neoplasm 19.91 19.07 4 13739 55 79730590
Postoperative adhesion 19.86 19.07 6 13737 468 79730177
Lymphatic system neoplasm 19.52 19.07 4 13739 61 79730584
Dizziness 19.44 19.07 156 13587 526285 79204360
Keratitis 19.37 19.07 11 13732 4311 79726334
Sinusitis 19.18 19.07 5 13738 195496 79535149
Diabetes mellitus 19.18 19.07 42 13701 78348 79652297

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC H01CB03 SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
HYPOTHALAMIC HORMONES
Somatostatin and analogues
FDA MoA N0000000194 Somatostatin Receptor Agonists
MeSH PA D000970 Antineoplastic Agents
FDA EPC N0000175904 Somatostatin Analog

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

DiseaseRelationSNOMED_IDDOID
Acromegaly indication 74107003 DOID:2449
Hypersomatotropic gigantism indication 86073008
Thyroid-stimulating hormone secreting pituitary tumour indication 127024001 DOID:1785
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Hypothyroidism contraindication 40930008 DOID:1459
Bradycardia contraindication 48867003
Hyperglycemia contraindication 80394007 DOID:4195
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
Hypoglycemic disorder contraindication 237630007
Calculus in biliary tract contraindication 266474003




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.65 acidic
pKa2 12.16 acidic
pKa3 12.71 acidic
pKa4 13.18 acidic
pKa5 13.43 acidic
pKa6 13.67 acidic
pKa7 10.31 Basic
pKa8 6.97 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOMATULINE DEPOT IPSEN PHARMA N022074 Aug. 30, 2007 RX SOLUTION SUBCUTANEOUS Sept. 15, 2024 TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY
EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOMATULINE DEPOT IPSEN PHARMA N022074 Aug. 30, 2007 RX SOLUTION SUBCUTANEOUS Sept. 15, 2024 TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY
EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOMATULINE DEPOT IPSEN PHARMA N022074 Aug. 30, 2007 RX SOLUTION SUBCUTANEOUS Sept. 15, 2024 TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Somatostatin receptor type 5 GPCR AGONIST Ki 9.30 IUPHAR CHEMBL
Somatostatin receptor type 2 GPCR AGONIST Ki 9.60 IUPHAR CHEMBL
Somatostatin receptor type 4 GPCR Ki 7.18 PDSP
Somatostatin receptor type 1 GPCR Ki 6.30 PDSP
Somatostatin receptor type 3 GPCR AGONIST Ki 8 IUPHAR
Somatostatin receptor type 2 GPCR AGONIST Ki 9.10 IUPHAR
Somatostatin receptor type 3 GPCR AGONIST IC50 8.20 IUPHAR
Somatostatin receptor type 5 GPCR AGONIST Ki 7.60 IUPHAR
Somatostatin receptor type 2 GPCR AGONIST Ki 8.80 IUPHAR
Somatostatin receptor type 3 GPCR AGONIST Ki 6.90 IUPHAR

External reference:

IDSource
4026631 VUID
N0000179366 NUI
D04666 KEGG_DRUG
127984-74-1 SECONDARY_CAS_RN
4026631 VANDF
C0209211 UMLSCUI
CHEBI:135901 CHEBI
CHEMBL1201185 ChEMBL_ID
CHEMBL1201184 ChEMBL_ID
DB06791 DRUGBANK_ID
C060347 MESH_SUPPLEMENTAL_RECORD_UI
2031 IUPHAR_LIGAND_ID
6649 INN_ID
0G3DE8943Y UNII
71349 PUBCHEM_CID
236167 RXNORM
18121 MMSL
354365 MMSL
d04961 MMSL
005272 NDDF
005273 NDDF
327379003 SNOMEDCT_US
395765000 SNOMEDCT_US
429611006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
SOMATULINE DEPOT HUMAN PRESCRIPTION DRUG LABEL 1 15054-1060 INJECTION 60 mg SUBCUTANEOUS NDA 29 sections
SOMATULINE DEPOT HUMAN PRESCRIPTION DRUG LABEL 1 15054-1060 INJECTION 60 mg SUBCUTANEOUS NDA 29 sections
SOMATULINE DEPOT HUMAN PRESCRIPTION DRUG LABEL 1 15054-1060 INJECTION 60 mg SUBCUTANEOUS NDA 29 sections
SOMATULINE DEPOT HUMAN PRESCRIPTION DRUG LABEL 1 15054-1090 INJECTION 90 mg SUBCUTANEOUS NDA 29 sections
SOMATULINE DEPOT HUMAN PRESCRIPTION DRUG LABEL 1 15054-1090 INJECTION 90 mg SUBCUTANEOUS NDA 29 sections
SOMATULINE DEPOT HUMAN PRESCRIPTION DRUG LABEL 1 15054-1090 INJECTION 90 mg SUBCUTANEOUS NDA 29 sections
SOMATULINE DEPOT HUMAN PRESCRIPTION DRUG LABEL 1 15054-1120 INJECTION 120 mg SUBCUTANEOUS NDA 29 sections
SOMATULINE DEPOT HUMAN PRESCRIPTION DRUG LABEL 1 15054-1120 INJECTION 120 mg SUBCUTANEOUS NDA 29 sections
SOMATULINE DEPOT HUMAN PRESCRIPTION DRUG LABEL 1 15054-1120 INJECTION 120 mg SUBCUTANEOUS NDA 29 sections
Lanreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 69097-870 INJECTION 120 mg SUBCUTANEOUS NDA 26 sections
Lanreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 69097-870 INJECTION 120 mg SUBCUTANEOUS NDA 26 sections
Lanreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 69097-880 INJECTION 60 mg SUBCUTANEOUS NDA 26 sections
Lanreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 69097-880 INJECTION 60 mg SUBCUTANEOUS NDA 26 sections
Lanreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 69097-890 INJECTION 90 mg SUBCUTANEOUS NDA 26 sections
Lanreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 69097-890 INJECTION 90 mg SUBCUTANEOUS NDA 26 sections
Lanreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 76282-709 INJECTION 60 mg SUBCUTANEOUS NDA 27 sections
Lanreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 76282-710 INJECTION 90 mg SUBCUTANEOUS NDA 27 sections
Lanreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 76282-711 INJECTION 120 mg SUBCUTANEOUS NDA 27 sections