CDEK
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lutetium (177Lu) vipivotide tetraxetan

Trade name: Pluvicto

Small moleculeapprovedBreakthrough Therapy FDA

Approved

Mar 23, 2022

Clinical trial activity

77 trials · 73 clinical orgs · 1 marketing orgs

Phase 1
28
Phase 2
55
Phase 3
10
Phase 4
1

Earliest trial started Dec 1, 2016 (NCT03042468)

Timeline

2010s

  1. Jan 1, 2016

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2017

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2018

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Mar 23, 2022

    Novartis — Earliest FDA Approval

  2. Mar 23, 2022

    Novartis — Marketing Organization

  3. Mar 23, 2022

    Novartis — NDA Secondary Org

  4. Mar 23, 2022

    Novartis — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewBreakthroughMar 23, 2022

Chemistry & pharmacology

Mol. weight
1216.07 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Payload
177Lu

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Also known as

  • 177lu-psma-617
  • lu177-psma-617

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07219147Phase 1Dec 4, 2025City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07025512Phase 2Dec 3, 2025Novartis, University of Texas at Houston
NCT06964958Phase 2Nov 30, 2025Harvard University, Novartis
NCT07150715Phase 2Oct 31, 2025Novartis, University of California, Los Angeles
NCT07145177Phase 1Oct 31, 2025Novartis, University of California, San Francisco
NCT06783348Phase 2Oct 30, 2025Advanced Accelerator Applications, European Organisation for Research and Treatment of Cancer, Université catholique de Louvain
NCT07223034Phase 1Oct 27, 2025Memorial Sloan-Kettering Cancer Center, Novartis
NCT07200830Phase 3Oct 8, 2025National Cancer Institute (NCI)
NCT06894511Phase 2Sep 11, 2025Novartis
NCT06943495Phase 1Aug 15, 2025Canadian Institutes of Health Research (CIHR), Laval University, Novartis
NCT06959433Phase 3Aug 1, 2025University of Ankara
NCT07047118Phase 2Jul 3, 2025Novartis
NCT06855277Phase 3Jul 1, 2025Novartis
NCT06866938Phase 2Apr 11, 2025University of Lyon
NCT06852820Phase 2Apr 1, 2025Case Western Reserve University, Novartis
NCT06738303Phase 2Mar 15, 2025Case Western Reserve University
NCT06574880Phase 1/Phase 2 (Phase 2)Mar 11, 2025Case Western Reserve University
NCT06798558Phase 2Mar 5, 2025Georgetown University, Hackensack University Medical Center, Novartis
NCT06780670Phase 2/Phase 3 (Phase 3)Feb 27, 2025Novartis
NCT06785636Phase 1/Phase 2 (Phase 2)Feb 7, 2025Duke University, Pathos AI, Inc.
Showing 20 of 77 trials
Page 1 / 4

Organizations

Research & Development (73)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit291442021
Peter MacCallum Cancer CentreAcademic/Hospital8622018
Advanced Accelerator ApplicationsFor profit5132020
Chinese Academy of Medical SciencesAcademic/Hospital5522017
National Cancer Institute (NCI)Government5232019
EndocyteFor profit4122018
University of California, Los AngelesAcademic/Hospital4312017
University of California, San FranciscoAcademic/Hospital4422019
Australian and New Zealand Urogenital and Prostate Cancer Trials GroupAcademic/Hospital3212018
Case Western Reserve UniversityAcademic/Hospital3312025
Istituto Nazionale per lo Studio e la Cura dei TumoriAcademic/Hospital3312017
Prostate Cancer FoundationAcademic/Hospital3022019
Australasian Radiopharmaceutical Trials networkAcademic/Hospital2012018
Australian Nuclear Science and Technology OrganisationAcademic/Hospital2012018
Cornell UniversityAcademic/Hospital2222016
Curie InstituteAcademic/Hospital2212024
Harvard UniversityAcademic/Hospital2222024
Janssen Pharmaceutica NVFor profit2022024
Medical University of ViennaAcademic/Hospital2212024
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital2212021
73 organizations
Page 1 / 4

Marketing (4)

OrganizationOrg typeRelationshipDate
NovartisFor profitMKTGMar 23, 2022
NovartisFor profitNDA2Mar 23, 2022
NovartisFor profitSYNMar 23, 2022
NovartisFor profitNDAMar 23, 2022