Overview
Dotatate gallium (Ga-68) is a somatostatin-2 receptor analog which is radiolabeled with gallium 68 as a positron-emitting radioisotope. Ga-68 dotatate has a high affinity for somatostatin-2 receptor and it is rapidly excreted from the nontarget sites which gives it an ideal candidate for imaging neuroendocrine tumors. Dotatate gallium (Ga-68) explotes its ability to detect somatostatin receptor scintigraphy and this characteristic tends to change with tumor grade which gives Ga-68 dotate a high diagnostic value. Dotatate gallium 68 was developed by Advanced Accelerator Applications USA, Inc. and FDA approved in June 1, 2016.
Indication
Dotatate gallium 68 is one of the most prominent radiopharmaceuticals used in imaging with positron emission tomography. It binds to the somatostatin-2 receptor which is usually overexpressed in many neuroendocrine tumors in both adult and pediatric patients. The neuroendocrine tumors are bening or malignant tumors produced in the hormone producing cells of the neuroendocrine system.
Associated Conditions
- Neuroendocrine Tumors
Research Report
A Comprehensive Monograph on Dotatate Gallium Ga-68: A Radiopharmaceutical for Neuroendocrine Tumor Imaging
I. Dotatate Gallium Ga-68: A Molecular and Physicochemical Characterization
Dotatate gallium Ga-68 is a sophisticated radiopharmaceutical agent that has fundamentally altered the diagnostic landscape for neuroendocrine tumors. Its design and function are rooted in a modular molecular architecture, combining a biologically active peptide with a positron-emitting radionuclide via a stable chelator. A thorough understanding of its chemical identity and properties is essential to appreciate its mechanism of action and clinical utility.
1.1 Nomenclature and Chemical Identifiers
The agent is most commonly referred to as Dotatate gallium Ga-68 or Gallium (Ga 68) dotatate.[1] Its systematic chemical name, reflecting its intricate structure, is
gallium;2-carbamoyl]-7--16-[(4-hydroxyphenyl)methyl]-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicos-19-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-2-oxoethyl]-7,.[2]
In the clinical and research settings, it is known by several synonyms, including [Ga-68] Dotatate, Gallium oxodotreotide Ga-68, and CHEMBL262135.[2] In the United States, it is commercialized under the brand name
Netspot.[1] Internationally, it has also been referred to by the name Somakit-TATE.[5] For unambiguous identification in scientific databases and regulatory filings, it is assigned specific codes: DrugBank ID DB13925, Chemical Abstracts Service (CAS) Number 1027785-90-5, and Unique Ingredient Identifier (UNII) 9L17Y0H71P.[3]
1.2 Structure, Formula, and Computed Properties
The molecular formula of Dotatate gallium Ga-68 is C65H87GaN14O19S2, with a computed molecular weight of approximately 1502.3 g/mol.[2] The molecule is a complex conjugate, meticulously engineered with three distinct functional components:
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/25 | Phase 3 | Recruiting | University Hospital, Grenoble | ||
2024/06/28 | Phase 1 | Recruiting | |||
2024/05/24 | Phase 1 | Recruiting | |||
2023/10/19 | Phase 3 | Recruiting | |||
2023/08/14 | Phase 1 | Completed | |||
2022/01/10 | Phase 2 | UNKNOWN | Central Hospital, Nancy, France | ||
2021/10/06 | Early Phase 1 | Recruiting | |||
2020/12/30 | Phase 1 | UNKNOWN | |||
2020/10/30 | Phase 1 | Recruiting | |||
2019/08/28 | N/A | Recruiting |
FDA Drug Approvals
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EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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Health Canada Drug Approvals
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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
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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