CDEK
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tagraxofusp-erzs

Trade name: elzonris

Recombinant proteinapprovedADCOrphan Drug FDABreakthrough Therapy FDA

Approved

Dec 21, 2018

Tagraxofusp, sold under the brand name Elzonris, is an anti-cancer medication for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). — Wikipedia

Clinical trial activity

20 trials · 18 clinical orgs · 1 marketing orgs

Phase 1
14
Phase 2
14
Phase 3
0
Phase 4
0

Earliest trial started Sep 1, 2014 (NCT02113982)

Timeline

2010s

  1. Mar 26, 2012

    Stemline Therapeutics, Inc. — IND Organization

  2. Mar 26, 2012

    Stemline Therapeutics, Inc. — IND Organization

  3. Jun 6, 2013

    Orphan Drug Designation

  4. Jan 1, 2014

    Stemline Therapeutics, Inc. — Earliest Phase 1 Sponsor(trial)

  5. Dec 21, 2018

    Stemline Therapeutics, Inc. — Earliest FDA Approval

  6. Dec 21, 2018

    Stemline Therapeutics, Inc. — Marketing Organization

  7. Dec 21, 2018

    Stemline Therapeutics, Inc. — NDA Organization

2020s

  1. Jan 1, 2020

    Earliest Phase 2 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewBreakthroughDec 21, 2018

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Multi-specific
No
Payload
diphtheria toxin

Oral

No

Parenteral

Yes

Topical

No

Black box warningFirst in class

Sources

Also known as

  • sl-401
  • tagraxofusp-erzs

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07148180Phase 1/Phase 2 (Phase 2)Feb 28, 2026Harvard University, Pipeline Therapeutics, Inc.
NCT07007052Phase 2Dec 1, 2025AbbVie, French Innovative Leukemia Organisation, Pipeline Therapeutics, Inc.
NCT06561152Phase 1/Phase 2 (Phase 2)Jan 31, 2025Pipeline Therapeutics, Inc., Stanford University
NCT06498973Phase 1Jan 20, 2025City of Hope National Medical Center, National Cancer Institute (NCI)
NCT06456463Phase 2Nov 30, 2024Pipeline Therapeutics, Inc.
NCT05720988Phase 1Aug 3, 2024Pipeline Therapeutics, Inc., University of California, Los Angeles
NCT06414681Early Phase 1 (Phase 1)May 31, 2024University of Kansas
NCT05442216Phase 2Dec 31, 2022Hoosier Cancer Research Network, Pipeline Therapeutics, Inc., University of North Carolina at Chapel Hill
NCT05476770Phase 1Nov 11, 2022University of Southern California, University of Washington
NCT05233618Phase 1Jul 13, 2022University of Virginia
NCT05032183Phase 1/Phase 2 (Phase 2)Feb 28, 2022University of Texas at Houston
NCT05038592Phase 1/Phase 2 (Phase 2)Dec 31, 2021University of Texas at Houston
NCT04342962Phase 2Jul 31, 2020Gruppo Italiano Malattie EMatologiche dell'Adulto
NCT04216524Phase 2Apr 30, 2020National Cancer Institute (NCI), University of Texas at Houston
NCT04317781Phase 2Mar 27, 2020National Cancer Institute (NCI), University of Texas at Houston
NCT03113643Phase 1Jun 26, 2017Harvard University, Stemline Therapeutics, Inc.
NCT02661022Phase 1/Phase 2 (Phase 2)Jan 1, 2016Stemline Therapeutics, Inc.
NCT02270463Phase 1/Phase 2 (Phase 2)Feb 1, 2015Stemline Therapeutics, Inc.
NCT02268253Phase 1/Phase 2 (Phase 2)Dec 1, 2014Stemline Therapeutics, Inc.
NCT02113982Phase 1/Phase 2 (Phase 2)Sep 1, 2014Stemline Therapeutics, Inc., The Leukemia and Lymphoma Society
Showing 20 of 20 trials
Page 1 / 1

Organizations

Research & Development (18)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Pipeline Therapeutics, Inc.For profit6122022
Stemline Therapeutics, Inc.For profit5422014
University of Texas at HoustonAcademic/Hospital4412020
National Cancer Institute (NCI)Government3022020
Harvard UniversityAcademic/Hospital2222017
AbbVieFor profit1012025
City of Hope National Medical CenterAcademic/Hospital1112025
French Innovative Leukemia OrganisationAcademic/Hospital1112025
Gruppo Italiano Malattie EMatologiche dell'AdultoAcademic/Hospital1112020
Hoosier Cancer Research NetworkAcademic/Hospital1112022
Stanford UniversityAcademic/Hospital1112025
The Leukemia and Lymphoma SocietyAcademic/Hospital1012014
University of California, Los AngelesAcademic/Hospital1112024
University of KansasAcademic/Hospital1112024
University of North Carolina at Chapel HillAcademic/Hospital1012022
University of Southern CaliforniaAcademic/Hospital1112022
University of VirginiaAcademic/Hospital1112022
University of WashingtonAcademic/Hospital1012022
18 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
Stemline Therapeutics, Inc.For profitMKTGDec 21, 2018
Stemline Therapeutics, Inc.For profitINDMar 26, 2012
Stemline Therapeutics, Inc.For profitNDADec 21, 2018
Stemline Therapeutics, Inc.For profitSYNDec 21, 2018