Drug

Moxetumomab pasudotox

As of the edition of 20 October 2026, Moxetumomab pasudotox is an antibody drug conjugate: marketed, first approved in 2018 (US); acts on CD22 and EEF2; US protection ends in 2030.

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

The drug

Status
Marketed; latest approval 2018
Kind
Antibody drug conjugate
Brand name
Lumoxiti
First approved
13 September 2018 (US)
Approvals on record
1 in 1 region
Holder of the most recent approval
AstraZeneca
Registered trials
10, 4 stopped early
Disease areas
Blood and lymph; Cancer; Immune system; Nervous system

US protection

US protection ends in 2030.

US protection ends in 2030, 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 AstraZeneca. 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

2 company-target rows on route B because of this drug.

Companies on route B for this drug

In the product

2 company-target rows are on route B because of Moxetumomab pasudotox.

Targets

GeneProteinUniProt
EEF2Elongation factor 2P13639
CD22B-cell receptor CD22P20273

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated1000
Phase 15212
Phase 23102
Phase 31100
All trials10

Who has held its approvals

CompanyRoleYears
AstraZenecaAcquired holder and Lead sponsor of trials2007 to now
Innate PharmaEarlier holder2018 to now