Elranatamab

Trade name: Elrexfio

mAbapprovedMulti-specificOrphan Drug FDAFast Track FDABreakthrough Therapy FDA

Approved

Aug 14, 2023

Clinical trial activity

36 trials · 25 clinical orgs · 1 marketing orgs

Phase 1
11
Phase 2
26
Phase 3
5
Phase 4
1

Earliest trial started Nov 29, 2017 (NCT03269136)

Timeline

2010s

  1. Jan 1, 2017

    Pfizer — Earliest Phase 1 Sponsor(trial)

2020s

  1. Jan 1, 2021

    Pfizer — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2021

    Pfizer — Earliest Phase 3 Sponsor(trial)

  3. Oct 12, 2021

    Orphan Drug Designation

  4. Aug 14, 2023

    Pfizer — Earliest FDA Approval

  5. Aug 14, 2023

    Pfizer — Marketing Organization

  6. Aug 14, 2023

    Pfizer — NDA Secondary Org

  7. Aug 14, 2023

    Pfizer — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackBreakthroughAug 14, 2023

Chemistry & pharmacology

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

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06832865Phase 2Aug 1, 2026Harvard University, Pfizer, Sanofi
NCT07280013Phase 1Apr 30, 2026C4 Therapeutics, Inc.
NCT07247097Phase 2Apr 15, 2026Harvard University, Pfizer
NCT06988488Phase 1/Phase 2 (Phase 2)Oct 7, 2025Bristol-Myers Squibb, Celgene
NCT06997081Phase 2Sep 16, 2025Pfizer, University of Miami
NCT06974786Phase 2Aug 8, 2025Colorado Blood Cancer Institute, Pfizer, SCRI Development Innovations
NCT06918002Phase 3Jul 9, 2025Intergroupe Francophone du Myelome, Pfizer
NCT06947083Phase 2May 7, 2025Pfizer, University of South Florida
NCT06931704Phase 2May 1, 2025University of Nantes
NCT06799026Phase 1Jan 31, 2025Harvard University, Pfizer
NCT06483100Phase 2Dec 31, 2024National Comprehensive Cancer Network, Pfizer, Washington University in St. Louis
NCT06711705Phase 2Dec 31, 2024University of California, San Diego
NCT06421675Phase 2Nov 30, 2024McMaster University, Pfizer
NCT06645678Phase 1/Phase 2 (Phase 2)Oct 24, 2024Seoul National University
NCT06569147Phase 1/Phase 2 (Phase 2)Sep 1, 2024Harvard University
NCT06207799Phase 2Jul 17, 2024Pfizer, University of Texas at Houston
NCT06138275Phase 2Apr 24, 2024Harvard University, Pfizer
NCT06215118Phase 1Feb 20, 2024Bristol-Myers Squibb, Pfizer
NCT06183489Phase 2Jan 31, 2024European Myeloma Network, Pfizer
NCT06015542Phase 2Jan 1, 2024Odense University Hospital, Pfizer, University of Southern Denmark
Showing 20 of 36 trials
Page 1 / 2

Organizations

Research & Development (25)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PfizerFor profit281552017
Harvard UniversityAcademic/Hospital5522024
Bristol-Myers SquibbFor profit2022024
C4 Therapeutics, Inc.For profit1112026
CelgeneFor profit1112025
Colorado Blood Cancer InstituteAcademic/Hospital1012025
European Myeloma NetworkAcademic/Hospital1112024
GenentechFor profit1112023
Intergroupe Francophone du MyelomeAcademic/Hospital1112025
McMaster UniversityAcademic/Hospital1112024
National Comprehensive Cancer NetworkAcademic/Hospital1012024
Odense University HospitalAcademic/Hospital1012024
PETHEMA FoundationAcademic/Hospital1112023
RocheFor profit1012023
SanofiFor profit1012026
SCRI Development InnovationsFor profit1112025
Seoul National UniversityAcademic/Hospital1112024
University of California, San DiegoAcademic/Hospital1112024
University of MiamiAcademic/Hospital1112025
University of NantesAcademic/Hospital1112025
25 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
PfizerFor profitMKTGAug 14, 2023
PfizerFor profitNDA2Aug 14, 2023
PfizerFor profitNDAAug 14, 2023