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Development Programs
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Development Programes
These are the development programmes for new drug candidates that we are advancing on a complex-systems approach to drug discovery.
For each programme we publish the information that can be disclosed, taking account of the stage of development, intellectual property and partnering. What is disclosed will be updated as research and development progress.
Contents
01
How to read this table
03
Stage definitions
02
Programme list
Contents
01
How to read this table
02
Programme list
03
Stage definitions
How to Read
For each development programme the table shows the target disease or therapeutic area, the current stage of development and the partnering status. Stages are shown as basic research, non-clinical, manufacturing and CMC, clinical trials and clinical development, and regulatory submission.
Development Programs
Program
[Programme ID / name
[Programme ID / name
Indication
[Indication / 対象疾患・領域]
[Indication / 対象疾患・領域]
Development Stage
Non-clinical
Basic research
Partnering Status
Open for Partnering
Partnering Discussion Ongoing
Stage Definitions
Basic research
Discovery of new drug candidates, formation of research hypotheses, and scientific validation of composition, characteristics, mechanism of action and interactions
Non-clinical
The scientific evaluation of pharmacology, safety and related matters that is required before a candidate can proceed to clinical trials
Manufacturing and CMC
Work on process, quality attributes, specifications, stability and formulation, building the manufacturing and quality base that clinical development and regulatory submission depend on
Clinical trials and clinical development
Stage-by-stage evaluation, through clinical trials, of safety, efficacy and the other data required
Regulatory submission
Bringing together non-clinical, CMC and clinical data and, following discussion with the regulatory authorities, applying for approval as a pharmaceutical
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