Drug

Odronextamab

As of the edition of 20 October 2026, Odronextamab is an antibody: marketed, first approved in 2024 (EU); acts on CD3D, CD3E and CD3G and 1 more.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2024
Kind
Antibody
Brand name
Ordspono
First approved
22 August 2024 (EU)
Approvals on record
1 in 1 region
Holder of the most recent approval
Regeneron
Registered trials
16, 0 stopped early
Disease areas
Blood and lymph; Cancer; Immune system; Pregnancy and women's health; Skin and connective tissue; Urinary and reproductive

US protection

No US approval on record.

With no US approval on record there are no listed US patents or exclusivities.

This is the US only.

Companies that need a new molecule because of this drug

1 company-target row on route B because of this drug.

Companies on route B for this drug

In the product

1 company-target row is on route B because of Odronextamab.

Targets

GeneProteinUniProt
CD3DT-cell surface glycoprotein CD3 delta chainP04234
CD3ET-cell surface glycoprotein CD3 epsilon chainP07766
CD3GT-cell surface glycoprotein CD3 gamma chainP09693
MS4A1B-lymphocyte antigen CD20P11836

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated1000
Phase 15230
Phase 24040
Phase 36060
All trials16

Who has held its approvals

CompanyRoleYears
RegeneronApplicant and Lead sponsor of trials2023 to now