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DAIICHI SANKYO, INC.

DAIICHI SANKYO, INC. logo
🇯🇵Japan
Ownership
Subsidiary
Established
2010-01-01
Employees
10K
Market Cap
$79B
Website
http://daiichisankyo.us

Clinical Trials

569

Active:253
Completed:217

Trial Phases

6 Phases

Early Phase 1:3
Phase 1:337
Phase 2:79
+3 more phases

Drug Approvals

9

FDA:9

Drug Approvals

DATROWAY

Approval Date
May 21, 2025
FDA

Enhertu

Approval Date
Feb 22, 2024
FDA

SAVAYSA

Approval Date
Feb 6, 2024
FDA

VANFLYTA

Approval Date
Feb 5, 2024
FDA

Turalio

Approval Date
Nov 21, 2023
FDA

Welchol

Approval Date
Jun 10, 2022
FDA

Azor

Approval Date
Jun 7, 2022
FDA

Tribenzor

Approval Date
Jun 7, 2022
FDA

Evoxac

Approval Date
Jun 3, 2022
FDA

Clinical Trials

Distribution across different clinical trial phases (530 trials with phase data)• Click on a phase to view related trials

Phase 1
337 (63.6%)
Phase 3
80 (15.1%)
Phase 2
79 (14.9%)
Phase 4
25 (4.7%)
Not Applicable
4 (0.8%)
Early Phase 1
3 (0.6%)
phase_1_2
1 (0.2%)
phase_2_3
1 (0.2%)

Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer

Phase 3
Not yet recruiting
Conditions
Endometrial Cancer
Interventions
First Posted Date
2025-06-15
Last Posted Date
2025-06-15
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
710
Registration Number
NCT07022483

A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors

Phase 1
Not yet recruiting
Conditions
Recurrent or Metastatic Solid Tumors
Interventions
First Posted Date
2025-06-11
Last Posted Date
2025-07-08
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
76
Registration Number
NCT07015697

Real-World Outcomes of Patients With Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i

Active, not recruiting
Conditions
Advanced/Metastatic HER2-negative Breast Cancer
First Posted Date
2025-05-16
Last Posted Date
2025-05-28
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
2200
Registration Number
NCT06975371
Locations
🇺🇸

Flatiron Health, Inc, New York, New York, United States

Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer

Phase 3
Not yet recruiting
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2025-03-27
Last Posted Date
2025-05-06
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
686
Registration Number
NCT06899126

Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China

Recruiting
Conditions
HER2-positive Gastric Cancer
HER2-positive Gastroesophageal Junction
Interventions
First Posted Date
2025-02-26
Last Posted Date
2025-07-08
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
260
Registration Number
NCT06846996
Locations
🇨🇳

China-Japan Friendship Hospital, Beijing, China

🇨🇳

Peking Union Medical College Hospital, Beijing, China

🇨🇳

Peking University First Hospital, Beijing, China

and more 33 locations
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News

FDA Maintains Record-Breaking Approval Pace Despite Organizational Upheaval, Highlighting Three Breakthrough Therapies

The FDA has approved 84 drugs in 2025 so far, marking the second-highest total for this period despite major organizational changes including 3,500 staff layoffs.

HER2-Positive Gastric Cancer Pipeline Shows Robust Activity with 20+ Companies Developing Novel Therapies

DelveInsight's 2025 pipeline report reveals over 20 companies actively developing more than 20 innovative therapies for HER2-positive gastric cancer treatment.

Daiichi Sankyo's New CEO Charts Course for ADC Expansion Beyond Enhertu Success

Hiroyuki Okuzawa assumed leadership of Daiichi Sankyo two months ago, inheriting a company strengthened by three major pharmaceutical licensing deals worth up to $27 billion based on ADC technology.

AbbVie's Temab-A ADC Shows 63% Response Rate in EGFR-Mutated NSCLC Phase I Trial

AbbVie's antibody drug conjugate Temab-A achieved a 63% overall response rate in patients with advanced EGFR-mutated non-small cell lung cancer in Phase I trial results presented at ASCO 2025.

HER3-DXd Demonstrates Promising Intracranial Activity in Phase II TUXEDO-3 Trial for Brain Metastases

The phase II TUXEDO-3 trial showed patritumab deruxtecan (HER3-DXd) achieved intracranial response rates of 23.8% in metastatic breast cancer and 30% in advanced non-small cell lung cancer patients with active brain metastases.

Real-World Study Shows Safe Rechallenge with Trastuzumab Deruxtecan After Grade 1 Interstitial Lung Disease

A multi-institutional study of 1,476 patients found that 75% of those with grade 1 interstitial lung disease (ILD) were successfully rechallenged with trastuzumab deruxtecan, remaining on therapy for a median of 215 days.

Merck KGaA's ADC Precemtabart Tocentecan Shows Promising Safety and Efficacy in Metastatic Colorectal Cancer Trial

Merck KGaA's antibody-drug conjugate precemtabart tocentecan demonstrated safety and tolerability in a Phase Ib trial for metastatic colorectal cancer patients.

Merck and Daiichi Sankyo Withdraw FDA Application for Lung Cancer ADC After Survival Data Disappoints

Merck and Daiichi Sankyo withdrew their FDA application for patritumab deruxtecan, an antibody-drug conjugate targeting EGFR-mutated non-small cell lung cancer, after the drug failed to demonstrate overall survival benefit.

Daiichi Sankyo and Merck Withdraw Patritumab Deruxtecan BLA After Phase 3 Trial Fails to Meet Overall Survival Endpoint

Daiichi Sankyo and Merck voluntarily withdrew their Biologics License Application for patritumab deruxtecan in EGFR-mutated NSCLC after the confirmatory HERTHENA-Lung02 Phase 3 trial failed to demonstrate statistically significant overall survival benefit.

ADC Market in NSCLC Projected to Reach $3.9 Billion by 2032, Led by AstraZeneca's Datroway

The antibody-drug conjugate (ADC) market in non-small-cell lung cancer is projected to grow at a 6.8% CAGR across seven major markets and exceed $3.9 billion by 2032.

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