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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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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
Brand Name
Status
Last Update
mycapssaNew Drug Application2020-12-06
octreotide acetateANDA2023-06-15
sandostatin lar depotNew Drug Application2022-10-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
acromegaly—D000172—
adenoma—D000236—
diarrheaHP_0002014D003967R19.7
pancreatic neoplasmsEFO_0003860D010190C25
pituitary neoplasms—D010911—
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
18 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Liver cirrhosisD008103EFO_0001422K74.0—151—6
Urinary tract infectionsD014552EFO_0003103N39.0———2—2
Drug-related side effects and adverse reactionsD064420T88.7———1—1
Hepatorenal syndromeD006530K76.7———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AscitesD001201HP_0001541R18——2——2
CystitisD003556EFO_1000025N30——1——1
Esophageal and gastric varicesD004932EFO_0009545I85——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatopulmonary syndromeD020065EFO_1001346K76.81—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I101————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Portal hypertensionD006975EFO_0000666K76.6————11
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)
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
6752
Protein name
somatostatin receptor type 2
Protein synonyms
SRIF-1, SS2R
Uniprot ID
Q9BWH1
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
6753
Protein name
somatostatin receptor type 3
Protein synonyms
SSR-28
Uniprot ID
Q53ZR7
Mouse ortholog
Sstr3 (20607)
somatostatin receptor type 3 (Q3UVV5)
Variants
Clinical Variant
No data
Financial
Mycapssa - Amryt Pharma
$
€
£
₣
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Sandostatin - Novartis
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 16,881 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,188 adverse events reported
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