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Lutetium Lu177 Edotreotide

Generic Name
Lutetium Lu177 Edotreotide
Drug Type
Small Molecule
Chemical Formula
C65H89LuN14O18S2
CAS Number
321835-55-6
Unique Ingredient Identifier
RGO812Q0C8

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Research Report

Published: Sep 23, 2025

Lutetium Lu177 Edotreotide (ITM-11): A Comprehensive Monograph on a Novel Radiopharmaceutical for Neuroendocrine Tumors

Executive Summary

Lutetium Lu177 Edotreotide, also known by the development code ITM-11, is an investigational, small-molecule radiopharmaceutical agent representing a significant advancement in the field of peptide receptor radionuclide therapy (PRRT). It is designed for the targeted treatment of somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs), a heterogeneous group of malignancies for which therapeutic options remain limited. The drug is a complex radioconjugate, composed of the somatostatin analogue edotreotide (DOTATOC), the chelator DOTA, and the therapeutic beta-emitting radioisotope Lutetium-177 (177Lu). Its mechanism of action relies on the high-affinity binding of edotreotide to SSTRs, particularly subtype 2, which are densely expressed on the surface of many NET cells. Following binding, the agent is internalized, delivering a highly localized and cytotoxic dose of radiation that induces DNA damage and subsequent tumor cell apoptosis.

The clinical development of Lutetium Lu177 Edotreotide is spearheaded by two pivotal Phase III trials. The recently completed COMPETE trial (NCT03049189) evaluated its efficacy and safety in patients with Grade 1 and 2 gastroenteropancreatic NETs (GEP-NETs) against the approved standard-of-care mTOR inhibitor, everolimus. The trial successfully met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS). Patients treated with Lutetium Lu177 Edotreotide experienced a median PFS of 23.9 months compared to 14.1 months for those receiving everolimus. Furthermore, the drug exhibited a favorable safety profile, with a lower incidence of treatment-related adverse events compared to the active comparator.

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/06/04
Phase 1
Not yet recruiting
2023/09/21
Phase 2
Recruiting
2023/06/26
Phase 3
Recruiting
Grupo Espanol de Tumores Neuroendocrinos
2022/05/24
Phase 3
Recruiting
2022/05/03
Early Phase 1
Recruiting
University Hospital, Basel, Switzerland
2021/06/07
Phase 2
Withdrawn
2020/02/19
Phase 2
Withdrawn
Excel Diagnostics and Nuclear Oncology Center
2019/12/11
Phase 2
UNKNOWN
University of Warmia and Mazury
2017/02/09
Phase 3
Active, not 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

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UK EMC Drug Information

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