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lutetium dotatate lu-177

Trade name: Lutathera

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Jan 26, 2018

DOTA-TATE is an eight amino acid long peptide, with a covalently bonded DOTA bifunctional chelator. — Wikipedia

Clinical trial activity

66 trials · 65 clinical orgs · 2 marketing orgs

Phase 1
22
Phase 2
48
Phase 3
9
Phase 4
0

Earliest trial started Nov 2, 2004 (NCT04029428)

Timeline

2000s

  1. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  2. Jan 12, 2009

    Orphan Drug Designation

2010s

  1. Jan 1, 2013

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2015

    Earliest Phase 1 Sponsor(trial)

  3. Jan 26, 2018

    Advanced Accelerator Applications — Earliest FDA Approval

  4. Jan 26, 2018

    AAA Pharmaceutical — NDA Secondary Org

  5. Jan 26, 2018

    Advanced Accelerator Applications — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackJan 26, 2018

Chemistry & pharmacology

Loading structure…

SMILES

[177Lu+3].C[C@@H](O)[C@@H](CO)NC(=O)[C@@H]1CSSC[C@H](NC(=O)[C@@H](CC2=CC=CC=C2)NC(=O)CN3CCN(CC([O-])=O)CCN(CC([O-])=O)CCN(CC([O-])=O)CC3)C(=O)N[C@@H](CC4=CC=C(O)C=C4)C(=O)N[C@H](CC5=CNC6=C5C=CC=C6)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1
Mol. weight
1595.559 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • (177lu-dotaotyr3)octreotate
  • 177lu dota-tate
  • 177lu-dotatate
  • 177lu-dotatate
  • 177lu-dotatate
  • 177lu-dota-tate
  • 177lu-edotreotide
  • 177lu-octreotate
  • (177lutetium-dota(o)tyr3)octreotate
  • dotatate-177lu
  • lu177 dota-tate
  • lu-177 dotate
  • lutate
  • lutetium dotatate lu-177

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06955169Phase 2Nov 30, 2025New York University, Novartis, RTOG Foundation, Yale University
NCT07150546Phase 1Sep 1, 2025Emory University, National Cancer Institute (NCI)
NCT06878664Phase 3Jun 12, 2025Grupo Espanol de Tumores Neuroendocrinos (GETNE), Institut Gustave Roussy, Universidad Complutense de Madrid
NCT06663072Phase 1Nov 15, 2024University of Chicago
NCT06326190Phase 2Nov 6, 2024European Organisation for Research and Treatment of Cancer, Novartis
NCT06607692Phase 2Oct 31, 2024Fundación de investigación HM
NCT06441331Phase 1Sep 30, 2024ITM Solucin GmbH
NCT06379217Phase 1Jul 29, 2024Novartis
NCT06395402Phase 2May 3, 2024Novartis, University of Iowa
NCT05773274Phase 2Mar 1, 2024Canadian Cancer Trials Group, National Cancer Institute (NCI)
NCT06122610Phase 1Feb 29, 2024University of Wisconsin
NCT05691465Phase 2Jan 19, 2024Johns Hopkins University, National Cancer Institute (NCI)
NCT05687123Phase 1Jan 6, 2024National Cancer Institute (NCI), Yale University
NCT06121271Phase 2Dec 18, 2023University of London
NCT07057622Phase 3Dec 12, 2023—
NCT05987176Phase 2Nov 1, 2023Imperial College London
NCT05918302Phase 3Oct 27, 2023Grupo Espanol de Tumores Neuroendocrinos (GETNE), MFAR Clinical Research, Universidad Autonoma de Barcelona
NCT05724108Phase 2Aug 30, 2023National Cancer Institute (NCI), Ohio State University
NCT05583708Phase 2Feb 28, 2023Cornell University
NCT05610826Phase 1/Phase 2 (Phase 2)Feb 1, 2023University of Chicago
Showing 20 of 66 trials
Page 1 / 4

Organizations

Research & Development (65)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government141022017
NovartisFor profit8322021
Advanced Accelerator ApplicationsFor profit6132019
Ohio State UniversityAcademic/Hospital4122020
FutureChemFor profit3322020
ITM Solucin GmbHFor profit3322017
Catholic University of KoreaAcademic/Hospital2022020
Erasmus University RotterdamAcademic/Hospital2222007
Free University of BrusselsAcademic/Hospital2212013
Fundación de investigación HMAcademic/Hospital2212020
Grupo Espanol de Tumores Neuroendocrinos (GETNE)Academic/Hospital2212023
Istituto Nazionale per lo Studio e la Cura dei TumoriAcademic/Hospital2212013
Mayo ClinicAcademic/Hospital2112019
National Institutes of Health (NIH)Government2022017
New York UniversityAcademic/Hospital2112019
University of ChicagoAcademic/Hospital2222023
University of IowaAcademic/Hospital2212020
University of LondonAcademic/Hospital2212020
Yale UniversityAcademic/Hospital2022024
ABX-CROFor profit1012017
65 organizations
Page 1 / 4

Marketing (2)

OrganizationOrg typeRelationshipDate
AAA PharmaceuticalFor profitNDA2Jan 26, 2018
Advanced Accelerator ApplicationsFor profitNDAJan 26, 2018