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Lutetium-177 oxodotreotide - Advanced Accelerator Applications

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Drug Profile

Lutetium-177 oxodotreotide - Advanced Accelerator Applications

Alternative Names: 177Lu-DOTA-TATE; 177Lu-DOTA0-Tyr3-Octreotate; 177Lu-labelled somatostatin analog peptide; [177Lu]Lu-DOTA-TATE; [Lu-177]-Dota-Tyr3-Octreotate; [Lu-177]-DOTATATE; AAA 601; F-1515; Lu-177-octreotate; Lu-DOTATATE; Lutate; Lutathera; LUTETIUM (177LU) OXODOTREOTIDE; Lutetium (177Lu) oxodotreotide - Advanced Accelerator Applications; Lutetium Lu 177 dotatate; lutetium Lu 177 dotatate; Lutetium-177-DOTA-Tyr-3-octreotate; Lutetium-177-DOTATATE; Octreotate Lu-177 DOTA Tyr-3; Octreotate-Lu-177

Latest Information Update: 28 Jan 2026

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At a glance

  • Originator BioSynthema
  • Developer Advanced Accelerator Applications; Australasian Gastro-Intestinal Trials Group; FUJIFILM Toyama Chemical; Georgetown University Medical Center; Gustave Roussy; King Faisal Specialist Hospital & Research Centre; National Cancer Centre (Singapore); National Cancer Institute (USA); Novartis Pharmaceuticals; NYU Langone Medical Center; Peking University; University Medical Center Utrecht
  • Class Antineoplastics; Drug conjugates; Peptides; Radioisotopes; Radiopharmaceuticals
  • Mechanism of Action Ionising radiation emitters
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Neuroendocrine tumours
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Neuroendocrine tumours
  • Phase II Glioblastoma; Meningioma; Nasopharyngeal cancer; Pancreatic cancer; Paraganglioma; Phaeochromocytoma; Small cell lung cancer

Most Recent Events

  • 28 Jan 2026 No recent reports of development identified for phase-I development in Neuroendocrine-tumours(Combination therapy, Inoperable/Unresectable, Second-line therapy or greater) in USA (IV, Infusion)
  • 31 Dec 2025 Novartis plans to file regulatory filings for somatostatin receptor positive Gastroenteropancreatic neuroendocrine tumors in 2028 (Novartis pipeline, December 2025)
  • 03 Jul 2025 Phase-II clinical trials in Neuroendocrine tumours (In children) (Parenteral) (Novartis Pharmaceuticals pipeline, July 2025)

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