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Research Report
An Expert Report on the Investigational Radiopharmaceutical 161Tb-DOTA-LM3
1. Introduction to 161Tb-DOTA-LM3
Overview as an Investigational Radiopharmaceutical
161Tb-DOTA-LM3 is a novel radiopharmaceutical agent currently under investigation for targeted radionuclide therapy (TRT). This compound integrates the therapeutic radionuclide Terbium-161 ($^{161}$Tb) with a DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid) chelator and a tumor-targeting peptide, LM3.[1] The primary therapeutic focus for 161Tb-DOTA-LM3 is on tumors that express the somatostatin receptor (SSTR), with a particular emphasis on neuroendocrine neoplasms (NENs).[1]
Rationale for Development
The development of 161Tb-DOTA-LM3 is driven by the persistent need for more efficacious treatments for NENs, especially in cases of metastatic disease where current options may be limited.[1] This investigational agent aims to harness the unique decay characteristics of $^{161}Tbandthespecifictumor−targetingpropertiesofanSSTRantagonist(LM3)topotentiallyofferanimprovementoverexistingpeptidereceptorradionuclidetherapy(PRRT)agents,suchasthoseutilizingLutetium−177(^{177}$Lu) with SSTR agonists like DOTATATE.[3] The impetus for its advancement is substantially supported by promising preclinical data, which indicate superior therapeutic efficacy and a manageable safety profile when compared to existing standards.[5]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/05/03 | Early Phase 1 | Recruiting | University Hospital, Basel, Switzerland |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
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
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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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
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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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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