Drug

Cetuximab sarotalocan

As of the edition of 20 October 2026, Cetuximab sarotalocan is an antibody drug conjugate: marketed, first approved in 2020 (JP); acts on EGFR.

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

The drug

Status
Marketed; latest approval 2020
Kind
Antibody drug conjugate
Brand name
Akalux
First approved
25 September 2020 (JP)
Approvals on record
1 in 1 region
Holder of the most recent approval
Rakuten Medical
Registered trials
3, 1 stopped early
Disease areas
Cancer; Lungs and airways

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.

Target

GeneProteinUniProt
EGFREpidermal growth factor receptorP00533

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase 22011
Phase 31010
All trials3

Who has held its approvals

CompanyRoleYears
Rakuten MedicalApplicant and Lead sponsor of trials2020 to now