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Drug ReportsOctreotide
Sandostatin, Mycapssa(octreotide)
Mycapssa, Sandostatin (octreotide) is a protein pharmaceutical. Octreotide was first approved as Sandostatin on 1988-10-21. It is used to treat acromegaly, adenoma, diarrhea, pancreatic neoplasms, and pituitary neoplasms in the USA. It has been approved in Europe to treat acromegaly. The pharmaceutical is active against somatostatin receptor type 2. In addition, it is known to target somatostatin receptor type 3 and somatostatin receptor type 5.
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3M
6M
YTD
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2Y
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EMA approval date
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Study first post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
musculoskeletal diseasesD009140
digestive system diseasesD004066
nervous system diseasesD009422
endocrine system diseasesD004700
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Mycapssa, Sandostatin (generic drugs available since 2005-03-28)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Octreotide acetate
Tradename
Company
Number
Date
Products
MYCAPSSAAmryt PharmaN-208232 RX2020-06-26
1 products, RLD, RS
SANDOSTATINNovartisN-019667 RX1988-10-21
3 products, RLD, RS
SANDOSTATIN LARNovartisN-021008 RX1998-11-25
3 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
No data
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration
Code
OCTREOTIDE ACETATE, MYCAPSSA, AMRYT
2023-06-26NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Octreotide Acetate, Mycapssa, Amryt
111414572040-12-28U-3232
102387092036-02-03U-2857
106953972036-02-03U-2857
110521262036-02-03U-2857
113380112036-02-03U-2857
115109632036-02-03U-2857
83291982029-09-17DP
85356952029-09-17U-2857
92658122029-09-17DP
95662462029-09-17DP
ATC Codes
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H01: Pituitary and hypothalamic hormones and analogues
— H01C: Hypothalamic hormones
— H01CB: Somatostatin and analogues
— H01CB02: Octreotide
V: Various drug classes in atc
— V09: Diagnostic radiopharmaceuticals
— V09I: Tumour detection radiopharmaceuticals
— V09IA: Technetium (99mtc) compounds
— V09IA07: Technetium (99mtc) hynic-octreotide
HCPCS
Code
Description
J2353
Injection, octreotide, depot form for intramuscular injection, 1 mg
J2354
Injection, octreotide, non-depot form for subcutaneous or intravenous injection, 25 mcg
Clinical
Clinical Trials
290 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AcromegalyD000172——5111617957
Neuroendocrine tumorsD018358EFO_1001901D3A.81024103750
Liver cirrhosisD008103EFO_0001422K74.01314411
NeoplasmsD009369—C802532—11
DiarrheaD003967HP_0002014R19.7—23139
ObesityD009765EFO_0001073E66.921—339
Hepatorenal syndromeD006530—K76.7—42127
Esophageal and gastric varicesD004932EFO_0009545I8511—315
Congenital hyperinsulinismD044903——11—1—3
AscitesD001201HP_0001541R18—211—3
Show 9 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Carcinoid tumorD002276—D3A.00454——11
Pancreatic neoplasmsD010190EFO_0003860C25151—18
Prostatic neoplasmsD011471—C61131——5
Breast neoplasmsD001943EFO_0003869C50—12—25
Liver neoplasmsD008113EFO_1001513C22.0—23—15
Colorectal neoplasmsD015179———14——5
Autosomal dominant polycystic kidneyD016891EFO_1001496Q61.2—23—15
Gastro-enteropancreatic neuroendocrine tumor———1—3——4
Diabetic retinopathyD003930EFO_0003770———4——4
Prader-willi syndromeD011218Orphanet_739Q87.11——1—23
Show 20 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neuroendocrine carcinomaD018278——16———7
NeuroblastomaD009447EFO_0000621—36———7
MeningiomaD008579EFO_0003098D32.923——16
MedulloblastomaD008527——14——15
Islet cell adenomaD007516EFO_0007331D13.723———5
Esophageal neoplasmsD004938—C15—1——45
PheochromocytomaD010673——22———4
Stomach neoplasmsD013274EFO_0003897C16—2——24
Acute kidney injuryD058186HP_0001919N17—1——23
ParagangliomaD010235——22———3
Show 34 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———5————5
Insulin resistanceD007333HP_0000855E88.8193———25
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.812———13
Central nervous system neoplasmsD016543——2————2
Prediabetic stateD011236EFO_1001121R73.032————2
Pure autonomic failureD054970——1————1
Orthostatic hypotensionD007024—I95.11————1
Von hippel-lindau diseaseD006623—Q85.831————1
Multiple endocrine neoplasia type 1D018761—E31.211————1
Merkel cell carcinomaD015266EFO_1001471C4A1————1
Show 14 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MalnutritionD044342EFO_0008572E40-E46————22
Weight lossD015431HP_0001824—————22
HemorrhageD006470MP_0001914R58————22
Hiv infectionsD015658EFO_0000764B20————22
MyocarditisD009205—I51.4————11
Brain neoplasmsD001932EFO_0003833C71————11
GlioblastomaD005909EFO_0000515—————11
GliomaD005910EFO_0000520—————11
GliosarcomaD018316——————11
Acoustic neuromaD009464HP_0009588—————11
Show 24 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOctreotide
INNoctreotide
Description
Octreotide, sold under the brand name Sandostatin among others, is an octapeptide that mimics natural somatostatin pharmacologically, though it is a more potent inhibitor of growth hormone, glucagon, and insulin than the natural hormone. It was first synthesized in 1979 by the chemist Wilfried Bauer, and binds predominantly to the somatostatin receptors SSTR2 and SSTR5.
Classification
Protein
Drug classpeptides: inhibition of growth hormone release
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C[C@@H](O)[C@@H]1NC(=O)[C@H](CCCCN)NC(=O)[C@@H](Cc2c[nH]c3ccccc23)NC(=O)[C@H](Cc2ccccc2)NC(=O)[C@@H](NC(=O)[C@H](N)Cc2ccccc2)CSSC[C@@H](C(=O)N[C@H](CO)[C@@H](C)O)NC1=O
Identifiers
PDB—
CAS-ID83150-76-9
RxCUI7617
ChEMBL IDCHEMBL1680
ChEBI ID—
PubChem CID448601
DrugBankDB00104
UNII IDRWM8CCW8GP (ChemIDplus, GSRS)
Target
Agency Approved
SSTR2
SSTR2
Organism
Homo sapiens
Gene name
SSTR2
Gene synonyms
NCBI Gene ID
Protein name
somatostatin receptor type 2
Protein synonyms
SRIF-1, SS2R
Uniprot ID
Mouse ortholog
Sstr2 (20606)
somatostatin receptor type 2 (Q91Y73)
Alternate
SSTR3
SSTR3
SSTR5
SSTR5
Organism
Homo sapiens
Gene name
SSTR3
Gene synonyms
NCBI Gene ID
Protein name
somatostatin receptor type 3
Protein synonyms
SSR-28
Uniprot ID
Mouse ortholog
Sstr3 (20607)
somatostatin receptor type 3 (Q3UVV5)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Mycapssa – Amryt Pharma
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Sandostatin – Novartis
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Tabular view
Estimated US medical usage
Octreotide
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 18,500 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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30,361 adverse events reported
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