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Eisai Co Ltd (JP:4523)
:4523
E1018
Healthy Participants, Malaria
Phase I
Recruiting
A Study of Oral E1018 in Healthy Adult Participants
Feb 25, 2025
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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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Bb-1701
Breast Cancer
Phase II
Active Not Recruiting
A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer
Nov 28, 2023
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Pegylated Liposomal Doxorubicin (Pld), Paclitaxel, Topotecan, Morab-202
Neoplasms, Ovarian
Phase II
Completed
A Study of MORAb-202 Versus Investigator's Choice Chemotherapy in Female Participants With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Nov 04, 2022
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Lemborexant, Pbo
Sleep Initiation And Maintenance Disorders
Phase II
Completed
A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder
Oct 21, 2022
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Morab-202
Carcinoma, Non-small-cell Lung
Phase II
Terminated
A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC)
Oct 10, 2022
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Pembrolizumab, Lenvatinib
Head And Neck Squamous Cell Carcinoma
Phase III
Completed
A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010/LEAP-010)-China Extension
Aug 29, 2022
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Pembrolizumab, Lenvatinib, E7386
Melanoma, Carcinoma, Hepatocellular, Colorectal Neoplasms
Phase I/II
Completed
A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors
Oct 14, 2021
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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 (4523) have in its pipeline
4523 is currently developing the following drugs: E1018, Lecanemab, E2814, E2086. These drug candidates are in various stages of clinical development as the company works toward FDA approval.