About Us

Pharmaceuticals

Research & Development

Tokyo New Drug Research Laboratories and Fuji Research Laboratories are the core centers for our research and development activities in Japan.

At the Tokyo New Drug Research Laboratories we conduct extensive research activities, including searching for new materials and product opportunities and their biological screening, molecular design, and preclinical studies such as biokinetic studies of medicine.

The Fuji Research Laboratories have two research divisions: 1) safety research and drug formulation research, where researchers are dedicated to product safety testing, and 2) research on drug delivery systems (DDS) for efficiently delivering drugs to the target site, development of new dosage forms, development of over-the-counter (OTC) drugs, and production of investigational agents.

We are working on research and development of our global products mainly in the United States, Europe and Asia.

Target Areas of R&D
Lifestyle -related diseases
Dyslipidemia
Type 2 Diabetes
Arteriosclerotic disease
Immunity Inflammation
Cancer
Inflammatory disease
Skin disease
Sensory organ diseases
Eye disease
Equilibrium and auditory function disorders
Pipeline

As of March 31, 2020

Development Code /
Nonproprietary Name
Classification Indications Development Phase
Pitavastatin HMG-CoA reductase inhibitor Dyslipidemia Filed(Malaysia, Vietnam)
Pitavastatin/Ezetimibe HMG-CoA reductase inhibitor/ NPC1L1 inhibitor Dyslipidemia Phase 3
Ripasudil Rho kinase inhibitor Glaucoma and ocular hypertension Filed(Malaysia, Vietnam, Thailand)
Diabetic retinopathy Phase 2
Fuchs endothelial corneal dystrophy Phase 2
Ripasudil/Brimonidine Rho kinase inhibitor/ Alpha-2 adrenergic receptor agonist Glaucoma and ocular hypertension Phase 3
Pemafibrate Selective PPARα modulator Dyslipidemia Phase 3
Non-alcoholic fatty liver Phase 2
Primary biliary cholangitis Phase 1
Pemafibrate/Tofogliflozin Selective PPARα modulator/ SGLT2 inhibitor - Phase 1
Peretinoin Apoptosis inducer Prevention of recurrence of liver cancer Phase 3
K-161 - Dry eye Phase 2
K-163 - Schizophrenia Phase 2
Indometacin/ℓ-menthol NSAIDs Acute pain Phase 1
K-755 - - Phase 1

<Notes>

  • Only a product in Clinical Stage is listed. This list does not include all of the products.
  • A product in Clinical Stage is defined as a product for which a regulatory procedure has been made for initiation of a first clinical trial (i.e. Investigational New Drug application in US, Clinical Trial Application in Europe, Clinical Trial Notification in Japan, or a similar process in other regions) and a regulatory procedure for discontinuation of development has not been made or regulatory approval has not been obtained in any regions where approval is anticipated.
  • A product assigned with International Nonproprietary Name (INN) is listed as its nonproprietary name. Otherwise, a development code is used.
  • This list shows the most advanced development phase for a product which is in more than one phase amongst countries and/or regions. In addition, countries and regions where regulatory application for marketing authorization (e.g. New Drug Application in US) has been filed with an approval yet to be granted, are also listed.
  • This list also includes a product in Clinical Stage for new indication(s) even if it has been already approved for different indication(s).