Drug

Zenocutuzumab

As of the edition of 20 October 2026, Zenocutuzumab is an antibody: marketed, first approved in 2024 (US); acts on ERBB2 and ERBB3; US protection ends in 2036.

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

The drug

Status
Marketed; latest approval 2024
Kind
Antibody
Brand name
Bizengri
First approved
4 December 2024 (US)
Approvals on record
1 in 1 region
Holder of the most recent approval
Merus
Registered trials
4, 1 stopped early
Disease areas
Cancer; Digestive system; Hormones; Lungs and airways; Pregnancy and women's health; Skin and connective tissue

US protection

US protection ends in 2036.

US protection ends in 2036, 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 Merus. 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 Zenocutuzumab.

Targets

GeneProteinUniProt
ERBB2Receptor tyrosine-protein kinase erbB-2P04626
ERBB3Receptor tyrosine-protein kinase erbB-3P21860

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated1000
Phase 23111
All trials4

Who has held its approvals

CompanyRoleYears
MerusOriginator and Lead sponsor of trials2024 to now