Daiichi Sankyo Company Limited (JP:4568)
:4568
Rosuvastatin, Atorvastatin, Ezetimibe, Bempedoic Acid
Hypercholesterolemia, Mixed Dyslipidemia, Coronary Atherosclerosis
Phase III
Not Yet Recruiting
A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
Mar 11, 2026
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Datopotamab Deruxtecan, Dexamethasone Mouthwash
Stomatitis
Phase IV
Not Yet Recruiting
An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -Related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer.
Jan 21, 2026
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Daiichi Sankyo Company Limited (4568) have in its pipeline
4568 is currently developing the following drugs: Rosuvastatin, Atorvastatin, Ezetimibe, Bempedoic Acid, Datopotamab Deruxtecan, Dexamethasone Mouthwash, Atorvastatin, Ezetimibe, Bempedoic Acid. These drug candidates are in various stages of clinical development as the company works toward FDA approval.