CDEK
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zenocutuzumab

Trade name: Bizengri

mAbapprovedBi-specificOrphan Drug FDAFast Track FDABreakthrough Therapy FDA

Approved

Dec 4, 2024

Clinical trial activity

4 trials · 8 clinical orgs · 2 marketing orgs

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

Earliest trial started Jan 1, 2015 (NCT02912949)

Timeline

2010s

  1. Jan 1, 2015

    Merus Labs — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2018

    Merus Labs — Earliest Phase 2 Sponsor(trial)

2020s

  1. Jul 22, 2020

    Orphan Drug Designation

  2. Dec 4, 2024

    Norgine — Earliest FDA Approval

  3. Dec 4, 2024

    Norgine — NDA Organization

  4. Dec 4, 2024

    Merus Labs — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackBreakthroughDec 4, 2024

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only
Multi-specific
Yes (Bi-specific)

Oral

No

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • mcla-128

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05588609Phase 2Nov 17, 2022Merus Labs
NCT03321981Phase 2Jan 15, 20184Clinics, Chiltern International, Merus Labs, Oncology Therapeutic Development, Q2 solutions
NCT02912949Phase 1/Phase 2 (Phase 2)Jan 1, 2015Chiltern International, Covance, Institut Gustave Roussy, LGC Limited, Merus Labs
NCT04100694N/A—Merus Labs
Showing 4 of 4 trials
Page 1 / 1

Organizations

Research & Development (8)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Merus LabsFor profit4422015
Chiltern InternationalFor profit2012015
4ClinicsFor profit1012018
CovanceFor profit1012015
Institut Gustave RoussyAcademic/Hospital1012015
LGC LimitedFor profit1012015
Oncology Therapeutic DevelopmentFor profit1012018
Q2 solutionsFor profit1012018
8 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
Merus LabsFor profitMKTGDec 4, 2024
NorgineFor profitNDADec 4, 2024