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Drug ReportsEdotreotide
Gallium ga 68 edotreotide, Somakit toc(edotreotide)
Gallium Ga Edotreotide, SomaKit TOC (edotreotide) is a small molecule pharmaceutical. Edotreotide was first approved as Somakit toc on 2016-12-08. It has been approved in Europe to treat neuroendocrine tumors and radionuclide imaging. It is known to target somatostatin receptor type 2.
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FDA approval date
EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
diagnosisD003933
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gallium ga-68 edotreotide
Tradename
Company
Number
Date
Products
GALLIUM GA 68 EDOTREOTIDEUniversity of IowaN-210828 RX2019-08-21
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ga-68-dotatocNew Drug Application2021-12-08
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
GALLIUM GA-68 EDOTREOTIDE, GALLIUM GA 68 EDOTREOTIDE, UIHC PET IMAGING
2026-08-21ODE-383, W
2024-08-21NCE, W
Patent Expiration
No data
ATC Codes
V: Various drug classes in atc
— V09: Diagnostic radiopharmaceuticals
— V09I: Tumour detection radiopharmaceuticals
— V09IX: Other diagnostic radiopharmaceuticals for tumour detection in atc
— V09IX09: Gallium (68ga) edotreotide
HCPCS
No data
Clinical
Clinical Trials
58 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neuroendocrine tumorsD018358EFO_1001901D3A.87165—1136
Pituitary neoplasmsD010911————1—12
GliomaD005910EFO_0000520——11—12
Thymus neoplasmsD013953—C37——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeuroblastomaD009447EFO_0000621—37——210
Carcinoid tumorD002276—D3A.0035——28
MedulloblastomaD008527——15——27
MeningiomaD008579EFO_0003098D32.923——27
ParagangliomaD010235——24——26
PheochromocytomaD010673——23——15
InsulinomaD007340———1——12
VipomaD003969———1——12
GastrinomaD015408———1——12
Breast neoplasmsD001943EFO_0003869C5011———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Central nervous system neoplasmsD016543——2————2
Islet cell adenomaD007516EFO_0007331D13.72————2
Von hippel-lindau diseaseD006623—Q85.831————1
Multiple endocrine neoplasia type 1D018761—E31.211————1
NeoplasmsD009369—C801————1
SarcomaD012509——1————1
LymphomaD008223—C85.91————1
MelanomaD008545——1————1
Paraneoplastic syndromesD010257——1————1
Gastro-enteropancreatic neuroendocrine tumorC535650——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471—C61————11
Small cell lung carcinomaD055752——————11
Merkel cell carcinomaD015266EFO_1001471C4A————11
GanglioneuromaD005729——————11
Brain stem neoplasmsD020295EFO_1001767—————11
Medullary carcinomaD018276——————11
GlucagonomaD005935——————11
MyocarditisD009205—I51.4————11
Brain neoplasmsD001932EFO_0003833C71————11
GlioblastomaD005909EFO_0000515—————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEdotreotide
INNedotreotide
Description
Edotreotide (USAN, also known as (DOTA0-Phe1-Tyr3) octreotide, DOTA-TOC, DOTATOC) is a substance which, when bound to various radionuclides, is used in the treatment and diagnosis of certain types of cancer. When used therapeutically it is an example of peptide receptor radionuclide therapy.
Classification
Small molecule
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](Cc2ccc(O)cc2)NC(=O)[C@@H](NC(=O)[C@@H](Cc2ccccc2)NC(=O)CN2CCN(CC(=O)O)CCN(CC(=O)O)CCN(CC(=O)O)CC2)CSSC[C@@H](C(=O)N[C@H](CO)[C@@H](C)O)NC1=O
Identifiers
PDB—
CAS-ID173606-11-6
RxCUI—
ChEMBL IDCHEMBL408350
ChEBI ID—
PubChem CID158782
DrugBankDB15494
UNII IDU194AS08HZ (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
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)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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10 adverse events reported
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