North American Pipeline
A legacy of exploratory research continues
Continuous advancements for patients
For more than 30 years, we have pursued scientific discoveries that address unmet clinical needs. The process of developing biologics and small-molecule drugs draws on the expertise of many, inside and outside the organization. Together, we work to investigate new molecules that have the potential to change medicine and change lives.
3 FDA drug approvals
between 2018 and 2019
Notably, our work in pharmaceutical research and development has led to 3 FDA drug approvals between 2018 and 2019; two of these were recognized with breakthrough medicine status. Data on these medicines earned recognition as Best of ASBMR (2013), Best of ASCO (2016), and Best of ASH (2018).
North American Pharmaceutical Pipeline
Our development work in North America is coordinated with global colleagues to bring new medicines to patients around the world in 4 therapeutic areas: neurology, immunology & allergy, oncology, and nephrology. Many of our programs target rare diseases for which patients lack sufficient treatment options.
Our North American teams are currently working on these assets. To view the most current global Kyowa Kirin pipeline, click here.
Click to sort by...
Sort by...
click on arrows to expand content
Proposed Indication Proposed Indication
Candidate Cand.
Phase
Mycosis fungoides and Sézary syndrome
Mogamulizumab KW-0761
Follicular lymphoma (FL),
marginal zone lymphoma (MZL)
Zandelisib combined
with Rituximab
ME-401
Atopic dermatitis
KHK4083
Follicular lymphoma (FL),
marginal zone lymphoma (MZL)
Zandelisib ME-401
Parkinson's Disease
KW-6356
Urothelial carcinoma
KHK2455
Solid tumor
KHK2455
B-cell malignancies
Zandelisib ME-401
ONCOLOGY
IMMUNOLOGY/ALLERGY
CENTRAL NERVOUS SYSTEM
Information accurate as of September 2021. Clinical testing of novel compound drugs is a complex process with no guaranteed results. Our hope in pursuing these proposed indications is to deliver to patients the advances that may have a profound impact on their disease. However, the safety and efficacy of these agents remain under investigation and have not been established or reviewed by regulatory agencies or health authorities.
Innovative clinical trial design
With our clinical research, Kyowa Kirin North America aspires to contribute to the enhancement of medical care, the advancement of medical and pharmaceutical sciences, and the overall improvement of patients' health and well-being. We have accomplished the swift completion of registrational programs with innovative trial design by applying innovative methods for data capture and analysis.
Clinical trials enable our researchers to responsibly evaluate the safety and efficacy of potential treatments. These trials investigate new treatments in terms of efficacy and the presence of side effects. We are committed to publishing the results of our trials in peer-reviewed publications and in presentations at medical conferences around the world.
When engaging in clinical research, we give maximum consideration to the protection of the human rights and safety of patients who participate in the research. Furthermore, we strive to comply with relevant laws and regulations and to secure transparency in clinical research, scientific validity, independence, and reliability.
Kyowa Kirin Group Clinical Research Policy
We have established and are implementing the Kyowa Kirin Group Clinical Research Policy, which summarizes our approach to clinical research and code of conduct. Visit clinicaltrials.gov to learn about clinical research sponsored by Kyowa Kirin.
To learn about clinical trials sponsored by Kyowa Kirin, visit clinicaltrials.gov and enter “Kyowa Kirin” into the search field labeled, “Other Terms.”
Our expertise
Cross-functional teams help create and deliver innovative new medicines.
Transcript
Expanded access
Expanded access programs provide a process to make investigational treatments available to physicians with patients who face life-threatening diseases for which no approved therapy is available and who cannot participate in a clinical study. Kyowa Kirin North America welcomes inquiries about access to treatments that are currently in clinical studies.
Please review our policy for expanded access to unapproved drugs.
Partner with Kyowa Kirin.
