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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

572

Active:251
Completed:222

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 (532 trials with phase data)• Click on a phase to view related trials

Phase 1
337 (63.3%)
Phase 3
80 (15.0%)
Phase 2
79 (14.8%)
Phase 4
25 (4.7%)
Not Applicable
6 (1.1%)
Early Phase 1
3 (0.6%)
phase_1_2
1 (0.2%)
phase_2_3
1 (0.2%)

A Study of DS3610a in Participants With Advanced Solid Tumor

Not Applicable
Not yet recruiting
Conditions
Solid Tumors
Metastatic Solid Tumors
Interventions
Drug: DS3610a
First Posted Date
2025-09-08
Last Posted Date
2025-09-08
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
70
Registration Number
NCT07159126

Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma

Not Applicable
Not yet recruiting
Conditions
Urothelial Cancer
Bladder Cancer
Interventions
First Posted Date
2025-08-19
Last Posted Date
2025-08-19
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
630
Registration Number
NCT07129993

Patterns of Care and Outcomes in Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer

Not yet recruiting
Conditions
Triple Negative Breast Cancer
Interventions
First Posted Date
2025-07-29
Last Posted Date
2025-08-26
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
760
Registration Number
NCT07092254

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
Recruiting
Conditions
Recurrent or Metastatic Solid Tumors
Interventions
First Posted Date
2025-06-11
Last Posted Date
2025-08-06
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
76
Registration Number
NCT07015697
Locations
🇺🇸

Research Site, Nashville, Tennessee, United States

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News

Hengrui Medicine Receives China's First EZH2 Inhibitor Approval for Hematological Malignancies

Hengrui Medicine's Zemetostat received conditional approval from China's NMPA, becoming the country's first EZH2 inhibitor for treating relapsed or refractory peripheral T-cell lymphoma.

I-Mab Strengthens Leadership Team with Three New Board Appointments and R&D Committee Formation

I-Mab appointed three seasoned biotech executives to key leadership positions, including Dr. Robert Lenz and Ms. Xin Liu to the Board of Directors and Dr. Ken Takeshita to the Scientific Advisory Board.

GIST Treatment Pipeline Shows Robust Activity with 28+ Therapies in Development Across Multiple Clinical Phases

DelveInsight's 2025 pipeline analysis reveals 25+ companies developing 28+ therapies for gastrointestinal stromal tumors, indicating strong industry investment in this rare cancer space.

Merck's Ifinatamab Deruxtecan Receives FDA Breakthrough Designation for Small Cell Lung Cancer

Merck and Daiichi Sankyo's ifinatamab deruxtecan received FDA Breakthrough Therapy Designation for extensive-stage small cell lung cancer patients who progressed after platinum-based chemotherapy.

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.

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