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AboutPricing
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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Clinical
Drug
Target
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Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Completion date
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
Bynfezia, Mycapssa, Octreotide, Sandostatin (discontinued: Octreotide, Sandostatin)
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
MYCAPSSAChiesi FarmaceuticiN-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
BYNFEZIA PENSun Pharmaceutical IndustriesN-213224 RX2024-09-27
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
bynfezia penNew Drug Application2020-02-19
mycapssaNew Drug Application2024-08-21
octreotideANDA2024-05-23
octreotide acetateANDA2024-12-19
octreotide octreotideANDA2019-09-12
sandostatinNew Drug Application2024-07-11
sandostatin lar depotNew Drug Application2024-07-11
sandostatin lar depot sandostatin lar depot demonstrationNew Drug Application2014-05-19
sandostatin lar depot sandostatin lar depot demonstration kitNew Drug Application2016-07-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
pancreatic neoplasmsEFO_0003860D010190C25
diarrheaHP_0002014D003967R19.7
pituitary neoplasms—D010911—
adenoma—D000236—
acromegaly—D000172—
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
296 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———359—17
DiarrheaD003967HP_0002014R19.7—121—4
NeoplasmsD009369—C80—1—2—3
ObesityD009765EFO_0001073E66.9—1—2—3
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277—C80.0—32——5
Retinal diseasesD012164HP_0000479H35.9——5——5
Diabetic retinopathyD003930EFO_0003770———5——5
Carcinoid tumorD002276—D3A.00—22——4
Liver diseasesD008107HP_0002910K70-K77—21——2
Autosomal dominant polycystic kidneyD016891EFO_1001496Q61.2—21——2
Malignant carcinoid syndromeD008303—E34.0—11——2
Serotonin syndromeD020230EFO_1001842——11——2
Hepatocellular carcinomaD006528—C22.0——2——2
Liver neoplasmsD008113EFO_1001513C22.0——2——2
Show 7 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neuroendocrine tumorsD018358EFO_1001901D3A.8—3——14
Neuroendocrine carcinomaD018278———3———3
Islet cell carcinomaD018273—C25.4—2———2
Congenital hyperinsulinismD044903——11———2
NesidioblastosisD046768EFO_0007318E16.911———2
Prostatic neoplasmsD011471—C61—2———2
Breast neoplasmsD001943EFO_0003869C50—1———1
Lung neoplasmsD008175HP_0100526C34.90—1———1
Pancreatic neoplasmsD010190EFO_0003860C25—1———1
HyperinsulinismD006946HP_0000842E16.1—1———1
Show 6 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SyndromeD013577——1———12
HypoglycemiaD007003HP_0001943E16.21————1
HemorrhageD006470MP_0001914R581————1
Gastrointestinal hemorrhageD006471HP_0002239K92.21————1
Irritable bowel syndromeD043183EFO_0000555K581————1
Pathologic dilatationD004108——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prader-willi syndromeD011218Orphanet_739Q87.11————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)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
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
No data
Financial
Revenue by drug
$
€
£
â‚£
Mycapssa – Amryt Pharma
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Sandostatin – Novartis
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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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Refill frequency
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 19,655 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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35,131 adverse events reported
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