pozelimab

Trade name: Veopoz

mAbapprovedOrphan Drug FDAFast Track FDA

Approved

Aug 18, 2023

Clinical trial activity

21 trials · 3 clinical orgs · 1 marketing orgs

Phase 1
6
Phase 2
10
Phase 3
8
Phase 4
1

Earliest trial started Jun 1, 2017 (NCT03115996)

Timeline

2010s

  1. Jan 1, 2017

    Regeneron — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2019

    Regeneron — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2019

    Regeneron — Earliest Phase 3 Sponsor(trial)

2020s

  1. Apr 13, 2020

    Orphan Drug Designation

  2. Aug 18, 2023

    Regeneron — Earliest FDA Approval

  3. Aug 18, 2023

    Regeneron — Marketing Organization

  4. Aug 18, 2023

    Regeneron — NDA Secondary Org

  5. Aug 18, 2023

    Regeneron — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewFast trackAug 18, 2023

Chemistry & pharmacology

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

Oral

No

Parenteral

Yes

Topical

No

Black box warningFirst in class

Sources

Also known as

  • regn3918

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07142343Phase 4Dec 23, 2025Regeneron
NCT07154745Phase 3Dec 19, 2025Regeneron
NCT07230834Phase 1Dec 15, 2025Regeneron
NCT06541704Phase 3Oct 28, 2024Regeneron
NCT06479863Early Phase 1 (Phase 1)Aug 8, 2024Austin Neuromuscular Center, Regeneron
NCT05744921Phase 3Mar 7, 2023Regeneron
NCT05133531Phase 3Jul 31, 2022Regeneron
NCT05131204Phase 3Mar 31, 2022Regeneron
NCT05070858Phase 3Sep 30, 2021Regeneron
NCT04940364Phase 1Aug 4, 2021Regeneron
NCT04811716Phase 2Jul 28, 2021Regeneron
NCT04888507Phase 2Jul 8, 2021Regeneron
NCT04601844Phase 1Nov 16, 2020Alnylam Pharmaceuticals, Regeneron
NCT04491838Phase 1Aug 3, 2020Regeneron
NCT04209634Phase 2/Phase 3 (Phase 3)Dec 30, 2019Regeneron
NCT04162470Phase 3Dec 3, 2019Regeneron
NCT03946748Phase 2May 16, 2019Regeneron
NCT03115996Phase 1Jun 1, 2017Regeneron
NCT06028594N/ARegeneron
NCT06003881N/ARegeneron
Showing 20 of 21 trials
Page 1 / 2

Organizations

Research & Development (3)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
RegeneronFor profit212052017
Alnylam PharmaceuticalsFor profit1012020
Austin Neuromuscular CenterAcademic/Hospital1112024
3 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
RegeneronFor profitMKTGAug 18, 2023
RegeneronFor profitNDA2Aug 18, 2023
RegeneronFor profitNDAAug 18, 2023