CDEK
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naxitamab

Trade name: Danyelza

mAbapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Nov 25, 2020

Clinical trial activity

44 trials · 22 clinical orgs · 1 marketing orgs

Phase 1
15
Phase 2
28
Phase 3
1
Phase 4
1

Earliest trial started Nov 1, 1987 (NCT00002458)

Timeline

1980s

  1. Jan 1, 1987

    Earliest Phase 2 Sponsor(trial)

1990s

  1. Jan 1, 1997

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jun 24, 2013

    Orphan Drug Designation

2020s

  1. Nov 25, 2020

    Y-Mabs, Inc — Earliest FDA Approval

  2. Nov 25, 2020

    Y-Mabs, Inc — Marketing Organization

  3. Nov 25, 2020

    Y-Mabs, Inc — NDA Secondary Org

  4. Nov 25, 2020

    Y-Mabs, Inc — NDA Organization

  5. Jan 1, 2023

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedBreakthroughNov 25, 2020

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 124i-humanized 3f8
  • 131i-3f8
  • 3f8
  • 3f8
  • 3f8
  • hu3f8
  • mab-3f8
  • mab-3f8
  • monoclonal antibody 3f8

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07011654Phase 1/Phase 2 (Phase 2)Sep 19, 2025University of Texas at Houston, Y-Mabs, Inc
NCT07027748Phase 1Jun 27, 2025Harvard University, Y-Mabs, Inc
NCT06540963Phase 2Nov 1, 2024Beat Childhood Cancer, Pennsylvania State University
NCT06528496Phase 2Jul 22, 2024Memorial Sloan-Kettering Cancer Center
NCT06026657Phase 1/Phase 2 (Phase 2)Dec 31, 2023Ohio State University
NCT06047535Phase 4Oct 31, 2023SciClone Pharmaceuticals
NCT06071897Phase 3Sep 1, 2023Federal Research Institute of Pediatric Hematology, Oncology and Immunology
NCT05968768Phase 2Aug 10, 2023Institution of Mother and Child, Warsaw, Poland, Wroclaw Medical University
NCT06013618Phase 2Jun 19, 2023Hainan People's Hospital, Sun Yat-Sen University
NCT05489887Phase 2Sep 14, 2022Medical University of South Carolina, Wake Forest University
NCT04909515Phase 2Oct 31, 2021Y-Mabs, Inc
NCT06438614Phase 2Aug 20, 2020Fundació Sant Joan de Déu
NCT03860207Phase 1/Phase 2 (Phase 2)Feb 22, 2019Memorial Sloan-Kettering Cancer Center
NCT03363373Phase 2Apr 3, 2018University of California, San Francisco, Y-Mabs, Inc
NCT03189706Early Phase 1 (Phase 1)Jun 12, 2017Cornell University, Y-Mabs, Inc
NCT03033303Phase 2Jan 23, 2017Cornell University
NCT02650648Phase 1Jan 1, 2016Cornell University
NCT02502786Phase 2Jul 1, 2015Cornell University, University of Southern California, University of Texas at Houston
NCT02307630N/ANov 1, 2014Cornell University, Y-Mabs, Inc
NCT02100930N/AMar 1, 2014Cornell University
Showing 20 of 44 trials
Page 1 / 3

Organizations

Research & Development (22)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Cornell UniversityAcademic/Hospital282831987
National Cancer Institute (NCI)Government10031997
Y-Mabs, IncFor profit6232014
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital3322019
University of Texas at HoustonAcademic/Hospital3112009
Band of ParentsAcademic/Hospital1012011
Beat Childhood CancerAcademic/Hospital1012024
Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyGovernment1112023
Fundació Sant Joan de DéuAcademic/Hospital1112020
Hainan People's HospitalAcademic/Hospital1012023
Harvard UniversityAcademic/Hospital1112025
Institution of Mother and Child, Warsaw, PolandAcademic/Hospital1112023
Medical University of South CarolinaAcademic/Hospital1012022
Ohio State UniversityAcademic/Hospital1112023
Pennsylvania State UniversityAcademic/Hospital1112024
SciClone PharmaceuticalsFor profit1112023
Sun Yat-Sen UniversityAcademic/Hospital1112023
United TherapeuticsFor profit1112009
University of California, San FranciscoAcademic/Hospital1012018
University of Southern CaliforniaAcademic/Hospital1012015
22 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
Y-Mabs, IncFor profitMKTGNov 25, 2020
Y-Mabs, IncFor profitNDA2Nov 25, 2020
Y-Mabs, IncFor profitNDANov 25, 2020