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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

579

Active:250
Completed:224

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

Phase 1
337 (62.8%)
Phase 3
80 (14.9%)
Phase 2
79 (14.7%)
Phase 4
26 (4.8%)
Not Applicable
10 (1.9%)
Early Phase 1
3 (0.6%)
phase_1_2
1 (0.2%)
phase_2_3
1 (0.2%)

A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia

Not yet recruiting
Conditions
Primary Hypercholesterolaemia
Mixed Dyslipidemia
Interventions
Drug: Combination of bempedoic acid and ezetimibe
First Posted Date
2025-10-03
Last Posted Date
2025-10-03
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
2560
Registration Number
NCT07206472

Evaluating Bioequivalence of a Fixed Dose Combination Versus Tablets of Bempedoic Acid / Ezetimibe and Rosuvastatin

Not Applicable
Not yet recruiting
Conditions
Healthy Subjects
Interventions
First Posted Date
2025-10-01
Last Posted Date
2025-10-01
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
58
Registration Number
NCT07201545
Locations
🇵🇹

Research Site, Porto, Portugal

A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer

Not Applicable
Not yet recruiting
Conditions
Advanced or Metastatic Adrenocortical Carcinoma
Metastatic Castration-resistant Prostate Cancer
Interventions
Drug: DS9051b
First Posted Date
2025-09-24
Last Posted Date
2025-09-24
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
40
Registration Number
NCT07189403
Locations
🇬🇧

Research Site, London, United Kingdom

Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Rosuvastatin

Not Applicable
Not yet recruiting
Conditions
Healthy Subjects
Interventions
First Posted Date
2025-09-19
Last Posted Date
2025-09-29
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
58
Registration Number
NCT07182383
Locations
🇵🇹

Research Site, Porto, Portugal

A Study of DS5361b in Participants With Advanced Solid Tumors

Not Applicable
Recruiting
Conditions
Advanced Solid Tumor
Interventions
Drug: DS5361b
First Posted Date
2025-09-19
Last Posted Date
2025-10-10
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
192
Registration Number
NCT07182591
Locations
🇺🇸

Research Site, San Antonio, Texas, United States

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News

Marengo Therapeutics Advances Phase 2 Expansion of Invikafusp Alfa-Trodelvy Combination for Metastatic Breast Cancer

Marengo Therapeutics has completed the Phase 1b safety run-in of its STARt-002 trial and determined the recommended Phase 2 dose for invikafusp alfa combined with Trodelvy in metastatic breast cancer patients.

Immuto Scientific Secures $8M Funding and Daiichi Sankyo Partnership to Advance AI-Driven Cancer Target Discovery

Immuto Scientific closed an oversubscribed $8 million Seed 2 financing round led by DYDX to advance its AI-enabled structural surfaceomics platform for drug discovery.

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.

Daiichi Sankyo Initiates Development of Triple-Combination Lipid-Lowering Tablet to Address Treatment Gaps

Daiichi Sankyo Europe announced the initiation of development for new oral triple combination tablets containing bempedoic acid, ezetimibe, and different doses of statins (atorvastatin or rosuvastatin) to improve LDL-C management and treatment adherence.

Gastric Cancer Pipeline Shows Robust Growth with 220+ Therapies in Development Across 200+ Companies

DelveInsight's 2025 pipeline report reveals over 200 companies developing 220+ therapeutic candidates for gastric cancer treatment across all clinical stages.

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.

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