Research & Development

R&D Organization

Our pharmaceutical R&D organization carries out its operations through four divisions, the R&D Administration Division, Licensing & Business Development Division, Discovery Research Laboratories and Clinical Development Division. The Discovery Research Laboratories, located in the same area as our head office (Kyoto), and our Drug Discovery Laboratories in Tsukuba, Ibaraki Prefecture, cooperate and search for new drug seeds.
Our Discovery Research Laboratories focus on the use of lowmolecular weight compounds as pharmaceuticals; pharmacological,toxicological, pharmacokinetic, formulation and pilot synthesis studies of drug seeds; and establishment of Nippon Shinyaku’s proprietary drug formulation technologies. Our Drug Discovery Laboratories carry out advanced research focused on genomic drug discovery and nucleic acid drugs. The Clinical Development Division is in charge of clinical trials to assess efficacy and safety in humans.

  • The Discovery Research Laboratories in Kyoto (Bldg.No.1)
  • The Discovery Research Laboratories in Tsukuba

R&D Compounds

< Domestic >

Stage Code No. Generic name Therapeutic field Indications Development
Pre-registratio NS-11 acamprosate calcium others maintenance of abstinence from alcohol in abstinent alcoholic patients licensed‐in from
Merck Serono International S.A.
Preparation for
NDA
NS-315 tramadol hydrochloride inflammation
/allergy
chronic non-cancer pain licensed‐in from
Grünenthal GmbH
Phase III LY450190 tadalafil urology urinary disorder caused by
benign prostatic hyperplasia
Eli Lilly Japan K.K.
Phase III NS-24 tramadol hydrochloride inflammation
/allergy
cancer pain
chronic non-cancer pain
licensed‐in from
Paladin Labs Inc.
Preparation for
Phase III
ACT-064992 macitentan cardiovascular pulmonary arterial hypertension co‐developed with
Actelion Pharmaceuticals Japan Ltd.
Phase II NS-304 selexipag cardiovascular pulmonary arterial hypertension
chronic thromboembolic pulmonary hypertension
co‐developed with
Actelion Pharmaceuticals Japan Ltd.
Phase II NS-141   inflammation
/allergy
pruritus associated with dermatitis original

< Overseas >

Stage Code No. Generic name Therapeutic field Indications Licensee
Approval NM441 prulifloxacin anti-infection bacterial infections Yuhan Corporation
Preparation for Phase III Lee's Pharmaceutical
Holdings Limited
Phase III NS-304 selexipag cardiovascular pulmonary arterial hypertension Actelion Pharmaceuticals Ltd.
Phase II NS-187 bafetinib hematologic malignancies B-cell chronic lymphocytic leukemia
advanced prostate cancer
chronic myelogenous leukemia(※)
glioblastoma multiforme(※※)
CytRx Corporation
Phase I/II NS-018   hematologic malignancies myelofibrosis  
(※)Preparation for Phase II (※※)Phase I
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