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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 |
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| 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 |