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

Stem definition	Drug id	CAS RN
peptides and glycopeptides	1546	108736-35-2

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
3	mg	P

ADMET properties:

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Property	Value	Reference
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
Vd (Volume of distribution)	0.20 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Aug. 30, 2007	FDA	IPSEN PHARMA
Dec. 12, 2020	PMDA	TEIJIN PHARMA LIMITED

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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

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FDA Adverse Event Reporting System (Pediatric)

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Pharmacologic Action:

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

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

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Disease	Relation	SNOMED_ID	DOID
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

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🐶 Veterinary Drug Use

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🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (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

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Orange Book patent data (new drug applications)

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
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

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Somatostatin receptor type 5	GPCR	P35346	SSR5_HUMAN	AGONIST	Ki	9.30	IUPHAR	CHEMBL
Somatostatin receptor type 2	GPCR	P30874	SSR2_HUMAN	AGONIST	Ki	9.60	IUPHAR	CHEMBL
Somatostatin receptor type 4	GPCR	P31391	SSR4_HUMAN		Ki	7.18	PDSP
Somatostatin receptor type 1	GPCR	P30872	SSR1_HUMAN		Ki	6.30	PDSP
Somatostatin receptor type 3	GPCR	P32745	SSR3_HUMAN	AGONIST	Ki	8	IUPHAR
Somatostatin receptor type 2	GPCR		SSR2_MOUSE	AGONIST	Ki	9.10	IUPHAR
Somatostatin receptor type 3	GPCR		SSR3_MOUSE	AGONIST	IC50	8.20	IUPHAR
Somatostatin receptor type 5	GPCR		SSR5_RAT	AGONIST	Ki	7.60	IUPHAR
Somatostatin receptor type 2	GPCR		SSR2_RAT	AGONIST	Ki	8.80	IUPHAR
Somatostatin receptor type 3	GPCR		SSR3_RAT	AGONIST	Ki	6.90	IUPHAR

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External reference:

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ID	Source
005272	NDDF
005273	NDDF
0G3DE8943Y	UNII
127984-74-1	SECONDARY_CAS_RN
18121	MMSL
2031	IUPHAR_LIGAND_ID
236167	RXNORM
327379003	SNOMEDCT_US
354365	MMSL
395765000	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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
SOMATULINE DEPOT	HUMAN PRESCRIPTION DRUG LABEL	1	15054-1060	INJECTION	60 mg	SUBCUTANEOUS	NDA	29 sections

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