Product Development

<Domestic>

May 11. 2022

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
Preparation for launch NS-32
(ferric derisomaltose)
gynecology iron deficiency anemia Licensed - in from
Pharmacosmos A/S
Nippon Shinyaku
NDA filing ZX008
(fenfluramine hydrochloride)
intractable disease・orphan disease Dravet syndrome Licensed - in from
Zogenix, Inc.
Zogenix, Inc.
Phase III ZX008
(fenfluramine hydrochloride)
intractable disease・orphan disease Lennox-Gastaut syndrome Licensed - in from
Zogenix, Inc.
Zogenix, Inc.
Preparation for Phase III GA101
(obinutuzumab)
inflammatory diseases lupus nephritis 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 I/II NS-87
(daunorubicin / cytarabine)
hematologic malignancies secondary acute myeloid leukemia Licensed - in from
Jazz Pharmaceuticals plc
Nippon Shinyaku
Preparation for Phase I/II NS-401
(tagraxofusp)
hematologic malignancies blastic plasmacytoid dendritic cell neoplasm Licensed - in from
The Menarini Group
Nippon Shinyaku
Phase I NS-229 inflammatory diseases inflammatory diseases Nippon Shinyaku Nippon Shinyaku
Phase I NS-917
(radgocitabine)
hematologic malignancies relapsed/refractory acute myeloid leukemia Licensed - in from
Delta-Fly Pharma, Inc.
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
Preparation for Phase III CAP-1002 intractable disease・orphan disease Duchenne muscular dystrophy Partnership:
Capricor Therapeutics, Inc.
Capricor Therapeutics, Inc.
Preparation for Phase II NS-018
(ilginatinib)
hematologic malignancies myelofibrosis Nippon Shinyaku Nippon Shinyaku