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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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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Primary completion date
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 Application2025-02-21
mycapssaNew Drug Application2024-08-21
octreotideANDA2024-05-23
octreotide acetateANDA2025-05-13
octreotide octreotideANDA2019-09-12
sandostatinNew Drug Application2025-01-21
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
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
302 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neuroendocrine tumorsD018358EFO_1001901D3A.814331531069
AcromegalyD0001725111717958
NeoplasmsD009369C80101162329
Carcinoid tumorD002276D3A.009106123
SyndromeD0135772843419
HemorrhageD006470MP_0001914R581224816
Liver cirrhosisD008103EFO_0001422K74.01315614
Malignant carcinoid syndromeD008303E34.0463113
DiarrheaD003967R19.7351312
ObesityD009765EFO_0001073E66.9413412
Show 24 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Islet cell adenomaD007516EFO_0007331D13.726210
Neuroendocrine carcinomaD018278268
NeuroblastomaD009447EFO_0000621367
MeningiomaD008579EFO_0003098D32.92517
Gastrointestinal neoplasmsD005770C26.9347
RecurrenceD0120081326
MedulloblastomaD0085271415
Esophageal neoplasmsD004938C15145
PheochromocytomaD010673224
Islet cell carcinomaD018273C25.4134
Show 45 more
Indications Phases 1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Weight lossD01543133
MalnutritionD044342EFO_0008572E40-E4622
Postoperative complicationsD01118322
PancreatitisD010195EFO_0000278K8522
Hiv infectionsD015658EFO_0000764B2022
Immunologic deficiency syndromesD007153D84.922
MyocarditisD009205I51.411
Brain neoplasmsD001932EFO_0003833C7111
GlioblastomaD005909EFO_000051511
GliomaD005910EFO_000052011
Show 41 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
$
£
Sandostatin Novartis
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Mycapssa Amryt Pharma
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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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 20,355 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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35,498 adverse events reported
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