＜Domestic＞
February 9. 2024
| Stage | Code No. (Generic name) |
Therapeutic field | Indications | Origin | Development |
|---|---|---|---|---|---|
| Launch Phase III |
NS-065/NCNP-01 (viltolarsen) |
intractable disease・orphan disease | Duchenne muscular dystrophy | Co - development: National Center of Neurology and Psychiatry |
Nippon Shinyaku |
| NDA filing | NS-87 (daunorubicin / cytarabine) |
hematologic malignancies | high-risk acute myeloid leukemia | Licensed - in from Jazz Pharmaceuticals plc |
Nippon Shinyaku |
| NDA filing | ZX008 (fenfluramine hydrochloride) |
intractable disease・orphan disease | Lennox-Gastaut syndrome | Distribution partnership: UCB S.A. (former : Zogenix, Inc.) |
UCB S.A. (former : Zogenix, Inc.) |
| Phase III | ZX008 (fenfluramine hydrochloride) |
intractable disease・orphan disease | CDKL5 deficiency disorder | Distribution partnership: UCB S.A. (former : Zogenix, Inc.) |
UCB S.A. (former : Zogenix, Inc.) |
| Phase III | GA101 (obinutuzumab) |
intractable disease・orphan disease | lupus nephritis | Licensed - in from Chugai Pharmaceutical Co., Ltd. |
Co - development: Chugai Pharmaceutical Co., Ltd. |
| Phase III | GA101 (obinutuzumab) |
intractable disease・orphan disease | pediatric nephrotic syndrome | Licensed - in from Chugai Pharmaceutical Co., Ltd. |
Co - development: Chugai Pharmaceutical Co., Ltd. |
| Phase III | GA101 (obinutuzumab) |
intractable disease・orphan disease | extra renal lupus | Licensed - in from Chugai Pharmaceutical Co., Ltd. |
Co - development: Chugai Pharmaceutical Co., Ltd. |
| Phase II | NS-304 (selexipag) |
cardiovascular | arteriosclerosis obliterans | Nippon Shinyaku | Nippon Shinyaku |
| Phase II | NS-304 (selexipag) |
intractable disease・orphan disease | pediatric pulmonary arterial hypertension | Nippon Shinyaku | Co - development: Janssen Pharmaceutical K.K. |
| Phase II | NS-580 | gynecology | endometriosis | Nippon Shinyaku | Nippon Shinyaku |
| Phase II | NS-580 | urological diseases | chronic prostatitis/chronic pelvic pain syndrome | Nippon Shinyaku | Nippon Shinyaku |
| Preparation for Phase II | NS-089/NCNP-02 (brogidirsen) |
intractable disease・orphan disease | Duchenne muscular dystrophy | Co - development: National Center of Neurology and Psychiatry |
Nippon Shinyaku |
| Preparation for Phase II | NS-229 | intractable disease・orphan disease | Eosinophilic granulomatosis with polyangiitis | Nippon Shinyaku | Nippon Shinyaku |
| Phase I/II | NS-401 (tagraxofusp) |
hematologic malignancies | blastic plasmacytoid dendritic cell neoplasm | Licensed - in from The Menarini Group |
Nippon Shinyaku |
| Preparation for Phase I/II | NS-050/NCNP-03 | intractable disease・orphan disease | Duchenne muscular dystrophy | Co - development: National Center of Neurology and Psychiatry |
Nippon Shinyaku |
| Phase I | NS-917 (radgocitabine) |
hematologic malignancies | relapsed/refractory acute myeloid leukemia | Licensed - in from Delta-Fly Pharma, Inc. |
Nippon Shinyaku |
| Phase I | NS-161 | inflammatory diseases | inflammatory diseases | Nippon Shinyaku | Nippon Shinyaku |
| Phase I | NS-025 | urological diseases | urological diseases | Nippon Shinyaku | Nippon Shinyaku |
| Phase I | NS-863 | cardiovascular | cardiovascular diseases | Nippon Shinyaku | Nippon Shinyaku |
＜Overseas＞
| Stage | Code No. (Generic name) |
Therapeutic field | Indications | Origin | Development |
|---|---|---|---|---|---|
| US Launch Phase III |
NS-065/NCNP-01 (viltolarsen) |
intractable disease・orphan disease | Duchenne muscular dystrophy | Co - development: National Center of Neurology and Psychiatry |
Nippon Shinyaku |
| Phase III | CAP-1002 | intractable disease・orphan disease | Duchenne muscular dystrophy | Partnership: Capricor Therapeutics, Inc. |
Capricor Therapeutics, Inc. |
| Phase II | NS-018 (ilginatinib) |
hematologic malignancies | myelofibrosis | Nippon Shinyaku | Nippon Shinyaku |
| Preparation for Phase II | NS-089/NCNP-02 (brogidirsen) |
intractable disease・orphan disease | Duchenne muscular dystrophy | Co - development: National Center of Neurology and Psychiatry |
Nippon Shinyaku |
| Preparation for Phase II | NS-229 | intractable disease・orphan disease | Eosinophilic granulomatosis with polyangiitis | Nippon Shinyaku | Nippon Shinyaku |
| Preparation for Phase I/II | NS-050/NCNP-03 | intractable disease・orphan disease | Duchenne muscular dystrophy | Co - development: National Center of Neurology and Psychiatry |
Nippon Shinyaku |