ENHERTU

(Fam-Trastuzumab Deruxtecan-Nxki)

ApprovedAntibody–drug conjugate

Daiichi Sankyo

ENHERTU is one of 180 small molecule programs targeting HER2-positive Early Breast Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

179

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

HER2-Positive Early Breast CancerApproved

Colorectal CancerNot yet recruiting

Breast CancerRecruiting

HER2-Positive Breast CancerRecruiting

Esophageal CancerRecruiting

Non-Small Cell Lung CancerActive, not recruiting

HER2-Positive Early Breast CancerApproved

Approved

Colorectal CancerPhase 2

Not yet recruiting

Breast CancerPhase 2

Recruiting

HER2-Positive Breast CancerPreclinical

Recruiting

Esophageal CancerPhase 1

Recruiting

Non-Small Cell Lung CancerPhase 1

Active, not recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

ENHERTU

Daiichi Sankyo

Approved

1 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

Duragesic-100

CCephalon

Preclinical

2 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 8

Duragesic

CCephalon

Preclinical

1 9

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 10

Tricor

JJagotec

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 1Recruiting

Esophageal Cancer

NCT05274048

Q4 2028

Phase 2Recruiting

Lymphoma, Non-Hodgkin

NCT02693535

Q2 2029

Phase 2Not yet recruiting

Colorectal Cancer

NCT07691489

Q1 2030

Phase 2Recruiting

Breast Cancer

NCT07459673

Clinical

Trials by Indication[1]

Esophageal Cancer1 trial

Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients

Recruiting·FFox Chase Cancer Center·Phase 1·NCT05274048·18 enrolled

Non-Small Cell Lung Cancer1 trial

ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer

Active, not recruiting·EEnliven Therapeutics·Phase 1·NCT05650879·198 enrolled

HER2-positive Breast Cancer1 trial

PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/II Platform Trial

Recruiting·QQuantumLeap Healthcare Collaborative·Preclinical·NCT05868226·280 enrolled

Lymphoma, Non-Hodgkin1 trial

Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Recruiting·AAmerican Society of Clinical Oncology·Phase 2·NCT02693535·4,200 enrolled

Breast Cancer1 trial

HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07459673·60 enrolled

2 more indications

Colorectal Cancer1 trial

A Phase 2 Trial of Trastuzumab Deruxtecan in Combination With Cetuximab in HER2-low Metastatic Colorectal Cancer That Has Progressed on Standard Therapies

Not yet recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07691489·27 enrolled

Unspecified1 trial

StrataPATH™ (Precision Indications for Approved Therapies)

Terminated·SStrata Oncology·Phase 2·NCT05097599·11 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 20, 2019

ENHERTU

BLA BLA761139

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Fam-Trastuzumab Deruxtecan-Nxki. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fam-Trastuzumab Deruxtecan-Nxki compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fam-Trastuzumab Deruxtecan-Nxki. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761139). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Daiichi Sankyo company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Antibody–drug conjugate[2]
Highest Phase: Approved[1]
Company: Daiichi Sankyo

ENHERTU

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2028

Q2 2029

Q1 2030

Trials by Indication[1]

Esophageal Cancer1 trial

Non-Small Cell Lung Cancer1 trial

HER2-positive Breast Cancer1 trial

Lymphoma, Non-Hodgkin1 trial

Breast Cancer1 trial

Colorectal Cancer1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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