Lecanemab, E2814
Alzheimer's Disease
Phase II
Active Not Recruiting
A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease
Sep 16, 2024
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E2086
Healthy Volunteers
Phase I
Completed
A Study of E2086 in Healthy Adult Participants
Jun 25, 2024
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E2086, Active Comparator
Narcolepsy Type 1 (Nt1)
Phase I
Completed
A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1
Jun 12, 2024
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Pembrolizumab, Belzutifan, Lenvatinib, Pembrolizumab/Quavonlimab, Keytruda, E7080
Carcinoma, Renal Cell
Phase III
Active Not Recruiting
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, vs Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)-China Extension Study
Jun 02, 2023
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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 Eisai Co Ltd (4523N) have in its pipeline
4523N is currently developing the following drugs: E2086, E2086, E6742. These drug candidates are in various stages of clinical development as the company works toward FDA approval.