Overview
Edotreotide gallium Ga-68 is an 8 amino acid peptide bound to the chelator 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA). Edotreotide gallium Ga-68 is indicated for localizing somatostatin receptor positive neuroendocrine tumors by positron emission tomography. Dotatate gallium Ga-68 is used for a similar indication. Dotatate gallium Ga-68 has lower tumor uptake but this data is highly variable between patients. Edotreotide gallium Ga-68 was granted FDA approval on 21 August 2019.
Indication
Edotreotide gallium Ga-68 is a radioactive diagnostic compound used in positron emission tomography (PET) for diagnose somatostatin receptor positive neuroendocrine tumors in pediatrics and adults.
Associated Conditions
- Neuroendocrine Tumors
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2016/12/23 | Early Phase 1 | Terminated | |||
2014/06/30 | Phase 1 | Terminated | |||
2013/06/05 | Phase 2 | Completed | Sue O'Dorisio |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| UIHC – P E T Imaging Center | 24417-681 | INTRAVENOUS | 4 mCi in 1 mL | 12/8/2021 |
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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