＜Domestic＞
November 13. 2024
| Stage | Code No. (Generic name) |
Therapeutic field | Indications | Origin | Development |
|---|---|---|---|---|---|
| Launch Phase III |
NS-065/NCNP-01 (viltolarsen) |
intractable diseases・orphan diseases | Duchenne muscular dystrophy | Co - development: National Center of Neurology and Psychiatry |
Nippon Shinyaku Co., Ltd. |
| Preparation for launch | ACT-064992D (macitentan/tadalafil) |
cardiovascular | pulmonary arterial hypertension | Janssen Pharmaceutical K.K. | Janssen Pharmaceutical K.K. |
| NDA filing | NS-304 (selexipag) |
intractable diseases・orphan diseases | pediatric pulmonary arterial hypertension | Nippon Shinyaku Co., Ltd. | Nippon Shinyaku Co., Ltd. |
| Phase III | ZX008 (fenfluramine hydrochloride) |
intractable diseases・orphan diseases | CDKL5 deficiency disorder | Distribution partnership: UCB S.A. (former : Zogenix, Inc.) |
UCB S.A. (former : Zogenix, Inc.) |
| Phase III | GA101 (obinutuzumab) |
intractable diseases・orphan diseases | lupus nephritis | Licensed - in from Chugai Pharmaceutical Co., Ltd. |
Co - development: Chugai Pharmaceutical Co., Ltd. |
| Phase III | GA101 (obinutuzumab) |
intractable diseases・orphan diseases | pediatric nephrotic syndrome | Licensed - in from Chugai Pharmaceutical Co., Ltd. |
Co - development: Chugai Pharmaceutical Co., Ltd. |
| Phase III | GA101 (obinutuzumab) |
intractable diseases・orphan diseases | extra renal lupus | Licensed - in from Chugai Pharmaceutical Co., Ltd. |
Co - development: Chugai Pharmaceutical Co., Ltd. |
| Phase III | LY3527727 (pirtobrutinib) |
hematologic malignancies | mantle cell lymphoma | Alliance agreement in Japan: Eli Lilly Japan K.K. | Eli Lilly Japan K.K. |
| Phase III | LY3527727 (pirtobrutinib) |
hematologic malignancies | chronic lymphocytic leukemia | Alliance agreement in Japan: Eli Lilly Japan K.K. | Eli Lilly Japan K.K. |
| Phase II | NS-304 (selexipag) |
cardiovascular | arteriosclerosis obliterans | Nippon Shinyaku Co., Ltd. | Nippon Shinyaku Co., Ltd. |
| Phase II | NS-580 | gynecology | endometriosis | Nippon Shinyaku Co., Ltd. | Nippon Shinyaku Co., Ltd. |
| Phase II | NS-580 | urological diseases | chronic prostatitis / chronic pelvic pain syndrome | Nippon Shinyaku Co., Ltd. | Nippon Shinyaku Co., Ltd. |
| Phase II | NS-089/NCNP-02 (brogidirsen) |
intractable diseases・orphan diseases | Duchenne muscular dystrophy | Co - development: National Center of Neurology and Psychiatry |
Nippon Shinyaku Co., Ltd. |
| Phase II | NS-229 | intractable diseases・orphan diseases | eosinophilic granulomatosis with polyangiitis | Nippon Shinyaku Co., Ltd. | Nippon Shinyaku Co., Ltd. |
| Phase I/II | NS-401 (tagraxofusp) |
hematologic malignancies | blastic plasmacytoid dendritic cell neoplasm | Licensed - in from The Menarini Group |
Nippon Shinyaku Co., Ltd. |
| Phase I/II | NS-050/NCNP-03 | intractable diseases・orphan diseases | Duchenne muscular dystrophy | Co - development: National Center of Neurology and Psychiatry |
Nippon Shinyaku Co., Ltd. |
| Phase I | NS-917 (radgocitabine) |
hematologic malignancies | relapsed/refractory acute myeloid leukemia | Licensed - in from Delta-Fly Pharma, Inc. |
Nippon Shinyaku Co., Ltd. |
| Phase I | NS-025 | urological diseases | urological diseases | Nippon Shinyaku Co., Ltd. | Nippon Shinyaku Co., Ltd. |
| Phase I | NS-863 | cardiovascular | cardiovascular diseases | Nippon Shinyaku Co., Ltd. | Nippon Shinyaku Co., Ltd. |
＜Overseas＞
| Stage | Code No. (Generic name) |
Therapeutic field | Indications | Origin | Development |
|---|---|---|---|---|---|
| US Launch Phase III |
NS-065/NCNP-01 (viltolarsen) |
intractable diseases・orphan diseases | Duchenne muscular dystrophy | Co - development: National Center of Neurology and Psychiatry |
Nippon Shinyaku Co., Ltd. |
| Rolling submission | CAP-1002 (deramiocel) |
intractable diseases・orphan diseases | Duchenne muscular dystrophy cardiomyopathy | Partnership: Capricor Therapeutics, Inc. |
Capricor Therapeutics, Inc. |
| Phase III | CAP-1002 (deramiocel) |
intractable diseases・orphan diseases | Duchenne muscular dystrophy | Partnership: Capricor Therapeutics, Inc. |
Capricor Therapeutics, Inc. |
| Phase II | NS-089/NCNP-02 (brogidirsen) |
intractable diseases・orphan diseases | Duchenne muscular dystrophy | Co - development: National Center of Neurology and Psychiatry |
Nippon Shinyaku Co., Ltd. |
| Phase II | NS-229 | intractable diseases・orphan diseases | eosinophilic granulomatosis with polyangiitis | Nippon Shinyaku Co., Ltd. | Nippon Shinyaku Co., Ltd. |
| Phase I/II | NS-050/NCNP-03 | intractable diseases・orphan diseases | Duchenne muscular dystrophy | Co - development: National Center of Neurology and Psychiatry |
Nippon Shinyaku Co., Ltd. |