Drug

Elranatamab

As of the edition of 20 October 2026, Elranatamab is an antibody: marketed, first approved in 2023 (US); acts on CD3E and TNFRSF17; US protection ends in 2035.

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

The drug

Status
Marketed; latest approval 2024
Kind
Antibody
Brand name
Elrexfio
First approved
14 August 2023 (US)
Approvals on record
7 in 4 regions
Holder of the most recent approval
Pfizer; 2 holders in all
Registered trials
53, 1 stopped early
Disease areas
Cancer; Immune system; Blood and lymph; Heart and blood vessels; Nutrition and metabolism; Infections

US protection

US protection ends in 2035.

US protection ends in 2035, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Pfizer. The date is computed, not published.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

2 listings count towards this date. The exact date and each listing are in the product.

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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 Elranatamab.

Targets

GeneProteinUniProt
CD3ET-cell surface glycoprotein CD3 epsilon chainP07766
TNFRSF17Tumor necrosis factor receptor superfamily member 17Q02223

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated10440
Phase 18260
Phase 2272241
Phase 36060
Phase 42020
All trials53

Who has held its approvals

CompanyRoleYears
PfizerOriginator, Applicant and Lead sponsor of trials2022 to now