Drug

Amrubicin

As of the edition of 20 October 2026, Amrubicin is a small molecule: in active development; acts on TOP2A.

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

The drug

Status
Active, 2026
Kind
Small molecule
Registered trials
19, 3 stopped early
Disease areas
Cancer; Lungs and airways; Blood and lymph; Skin and connective tissue; Heart and blood vessels; Immune system

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 on route B and 1 company on route A because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Amrubicin.

Companies on route A for this drug

In the product

1 company is on route A because of Amrubicin.

Target

GeneProteinUniProt
TOP2ADNA topoisomerase 2-alphaP11388

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase 13300
Phase 211802
Phase 35311
All trials19

Who ran its trials

CompanyRoleYears
Sumitomo PharmaLead sponsor of trials2006 to now
Bristol Myers SquibbLead sponsor of trials2006 to now
Marubeni PharmaceuticalsLead sponsor of trials2008 to now
SCRI Development InnovationsLead sponsor of trials2009 to now
Gilead SciencesLead sponsor of trials2025 to now