T-DXd

Phase 3Small molecule

Daiichi Sankyo

T-DXd is one of 137 small molecule programs targeting Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

136

Competitors

Pipeline

Status by Indication[3][1]

Indication

Breast CancerRecruiting

Ovarian CancerActive, not recruiting

Advanced CancerRecruiting

Non-Squamous NSCLCRecruiting

HER2 PositiveNot yet recruiting

Breast CancerPhase 2

Recruiting

Ovarian CancerPreclinical

Active, not recruiting

Advanced CancerPhase 3

Recruiting

Non-Squamous NSCLCPhase 1

Recruiting

HER2 PositivePreclinical

Not yet recruiting

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

T-DXd

Daiichi Sankyo

Phase 3

6 2

Zolymbus

AbbVie

Preclinical

1 3

Blenoxane

Bristol-Myers Squibb

Preclinical

1 4

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

Duragesic-100

CCephalon

Preclinical

2 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 8

Spravato

WWim Janssens

Preclinical

2 9

Tricor

JJagotec

Preclinical

1 10

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

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

Timeline

Expected Milestones

Q2 2027

PreclinicalActive, not recruiting

Ovarian Cancer

NCT04644068

PreclinicalRecruiting

Breast Cancer

NCT07134153

Phase 1Recruiting

Non-Squamous NSCLC

NCT04686305

Q1 2028

Phase 3Recruiting

Advanced Cancer

NCT06174987

Q3 2028

Phase 2Not yet recruiting

Breast Cancer

NCT06548178

Q4 2028

Phase 1Active, not recruiting

Solid Tumor

NCT06244485

Clinical

Trials by Indication[1]

Breast Cancer6 trials

Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management

Recruiting·SSOLTI Breast Cancer Research Group·Phase 2·NCT07371585·300 enrolled

Efficacy and Safety of T-DXd in Patients With HER2-positive and HER2-low Metastatic Breast Cancer: a Real-world Study

Completed·TThe First Affiliated Hospital with Nanjing Medical University··NCT07108595·142 enrolled

SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study

Not yet recruiting·PPeking University Cancer Hospital & Institute·Phase 2·NCT07417241·100 enrolled

Show 3 more trials

T-DXd Versus THP for Medium-risk HER2-positive Early Breast Cancer

Not yet recruiting·FFudan University·Phase 2·NCT06548178·242 enrolled

Evaluating Safety and Efficacy of INtrathecal or Ommaya ReserVoir Administration of T-DXd in Patients With HER2-Expressing Breast Cancer With Active Leptomeningeal and/or Brain Metastases Based on Systemic Therapy: Phase I/II Study

Recruiting·FFudan University·Preclinical·NCT07134153·139 enrolled

Premedication With Dexamethasone for Preventing Interstitial Lung Disease in Patients With Breast Cancer Treated With Trastuzumab Deruxtecan - MARGARET Trial

Not yet recruiting· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 3·NCT07828054·244 enrolled

HER2 Positive2 trials

Efficacy of T-Dxd in the Treatment of HER2-positive BCBM After Prior Pyrotinib

Unknown status·—··NCT06135194·30 enrolled

A Phase Ib/II Study of Trastuzumab Deruxtecan (T-DXd) in Combination With a RAGE Inhibitor in Patients With T-DXd-Resistant HER2-Positive or HER2-Low Metastatic Breast Cancer

Not yet recruiting·TThe Methodist Hospital Research Institute·Preclinical·NCT07785856·27 enrolled

Solid Tumor2 trials

A Phase 1, 2-Part, Multicenter, First-In-Human Dose-Escalation and Dose-Expansion Study of DS-1103a Combination Therapy in Subjects With Advanced Solid Tumors

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT05765851·128 enrolled

A Phase 1b, Multicenter, Open-Label Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors

Active, not recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT06244485·210 enrolled

Non-squamous NSCLC1 trial

Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC

Recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT04686305·244 enrolled

Advanced Cancer1 trial

A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT06174987·75 enrolled

1 more indication

Ovarian Cancer1 trial

A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies

Active, not recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Preclinical·NCT04644068·702 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for T-DXd. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — T-DXd compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for T-DXd. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Daiichi Sankyo company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Daiichi Sankyo

T-DXd

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q1 2028

Q3 2028

Q4 2028

Trials by Indication[1]

Breast Cancer6 trials

HER2 Positive2 trials

Solid Tumor2 trials

Non-squamous NSCLC1 trial

Advanced Cancer1 trial

Ovarian Cancer1 trial

References

Drug Info

Quick Facts

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