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| Stem definition | Drug id | CAS RN |
|---|---|---|
| somatostatin receptor agonists/antagonists | 5185 | 459831-08-4 |
| Molecule | Description |
|---|---|
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Synonyms:
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A radioconjugate consisting of the octreotide derivative edotreotide labeled with gallium 68 (Ga-68) with potential application in somatostatin receptor (SSTR) imaging in conjunction with positron emission tomography (PET). Similar to octreotide, gallium Ga 68-edotreotide binds to SSTRs, especially type 2 receptors, present on the cell membranes of many types of neuroendocrine tumor cells and their metastases, thereby allowing for imaging of SSTR-expressing cells upon PET. Gallium Ga 68-edotreotide is produced by substituting tyrosine for phenylalanine at the 3 position of the somatostatin analogue octreotide (Tyr3-octreotide or TOC) and chelating the substituted octreotide to Ga-68 via the macrocyclic chelating agent dodecanetetraacetic acid (DOTA).
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 21, 2019 | FDA | UIHC PET IMAGING | |
| Dec. 8, 2016 | EMA | Advanced Accelerator Applications |
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| Source | Code | Description |
|---|---|---|
| ATC | V09IX09 | VARIOUS DIAGNOSTIC RADIOPHARMACEUTICALS TUMOUR DETECTION Other diagnostic radiopharmaceuticals for tumour detection |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Positron emission tomography with computed tomography of whole body using gallium (68-Ga) dotatate | indication | 764693004 |
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| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 0.5-4mCi/ML | GALLIUM GA 68 EDOTREOTIDE | UIHC PET IMAGING | N210828 | Aug. 21, 2019 | RX | SOLUTION | INTRAVENOUS | Aug. 21, 2026 | EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY |
| 0.5-4mCi/ML | GALLIUM GA 68 EDOTREOTIDE | UIHC PET IMAGING | N210828 | Aug. 21, 2019 | RX | SOLUTION | INTRAVENOUS | Aug. 21, 2026 | FOR USE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR THE LOCALIZATION OF KNOWN SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT AND PEDIATRIC PATIENTS |
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Somatostatin receptor type 2 | GPCR | ANTAGONIST | Ki | 8.60 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| C3640098 | UMLSCUI |
| CHEBI:756835 | CHEBI |
| CHEMBL4297340 | ChEMBL_ID |
| 71661158 | PUBCHEM_CID |
| DB15494 | DRUGBANK_ID |
| D11651 | KEGG_DRUG |
| 1371422008 | SNOMEDCT_US |
| 018100 | NDDF |
| 2199391 | RXNORM |
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