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Trastuzumab Deruxtecan · Enhertu, DS-8201a

Antibody-drug conjugate · Cytotoxic, directed at HER2 (ERBB2) · developed by Daiichi Sankyo

Approved FDA, Sep 1998

4 Registered trials

What is Trastuzumab Deruxtecan?

Fam-trastuzumab deruxtecan-nxki is a HER2-directed antibody-drug conjugate combining a humanized anti-HER2 IgG1 with deruxtecan, a topoisomerase I inhibitor. After binding HER2 on tumor cells and internalization, the payload causes DNA damage and apoptotic cell death.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Enhertu, DS-8201a, DS-8201, T-DXd
Drug type: Antibody-drug conjugate
Targets: HER2 (ERBB2)
Mechanism: Cytotoxic, directed at HER2 (ERBB2)
Pathways: DNA damage, apoptosis, cell cycle arrest
Therapy area: Oncology
Developer: Daiichi Sankyo Inc.
In trials of: AZN, GILD, MRK
FDA status: Approved as Enhertu (September 25, 1998), BLA761139 · FDA label
UNII: 5384HK7574

✅ FDA-approved uses

HER2-Positive Early Breast Cancer (neoadjuvant treatment)
HER2-Positive Early Breast Cancer (adjuvant treatment)
HER2-Positive Metastatic Breast Cancer (first-line with pertuzumab)
HER2-Positive Metastatic Breast Cancer (monotherapy)
HER2-Low and HER2-Ultralow Metastatic Breast Cancer (HR-positive)
HER2-Low Metastatic Breast Cancer
HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer

From the indications section of the FDA label (version of May 15, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT07060807	Phase 3	Breast Neoplasms	Recruiting	MRK
NCT03734029	Phase 3	Breast Cancer	Completed	AZN
NCT03424005	Phase 1/2	Metastatic Breast Cancer	Recruiting	GILD
NCT07124000	N/A	Adenocarcinoma (NOS)	Recruiting	AZN

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Adenocarcinoma (NOS)Anal CancerBladder CancerBreast NeoplasmsCervical CancerEndometrial CancerEsophageal CancerGall Bladder CancerGastrointestinal Stromal TumourHead and Neck CancerLiver CancerMelanomaMetastatic Breast CancerMouth Cancer

Other drugs acting on ERBB2

Neratinib FDA approved Trastuzumab Emtansine FDA approved Zanidatamab FDA approved ADCT-502 Phase 1 BH-30643 Phase 1/2 CGT4255 Phase 1 CUDC-101 Phase 1 ELVN-002 Phase 1 Enozertinib Phase 1/2 NVL-330 Phase 1 TTX-MC138 Phase 1/2 Tuxobertinib Phase 1

Sources

Updated Oct 3, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z