Development Pipeline
Key clinical studies our Group is conducting in respect of the indications for which we are pursuing approvals in Japan, USA, China, and Europe. If multiple studies are underway in the same region or in relation to the same indication, only the study in the most advanced stage of development is shown.
As of January 31, 2024
Psychiatry & Neurology
Brand name/Product code (Generic name) | Proposed indication | Region | Development stage | |
---|---|---|---|---|
Small molecule | SEP-363856 (ulotaront hydrochloride) |
Schizophrenia | U.S. | Phase 3 |
Japan, China | Phase 2/3 | |||
Adjunctive major depressive disorder (aMDD) | U.S. | Phase 2/3 | ||
Generalized anxiety disorder (GAD) | U.S., Japan | Phase 2/3 | ||
Parkinson’s disease psychosis | U.S. | Phase 2 | ||
LATUDA® (lurasidone hydrochloride) |
(New usage: pediatric) Schizophrenia | Japan | Phase 3 | |
EPI-589 | Parkinson’s disease | U.S. | Phase 2 | |
Amyotrophic lateral sclerosis (ALS) | U.S. | Phase 2 | ||
Japan | Phase 2 (Investigator-initiated study) |
|||
SEP-378614 | To be determined | U.S. | Phase 1 | |
SEP-380135 | To be determined | U.S. | Phase 1 | |
DSP-0038 | Alzheimer’s disease psychosis | U.S. | Phase 1 | |
DSP-0187 | Narcolepsy | Japan | Phase 1 | |
DSP-3456 | Treatment resistant depression | U.S. | Phase 1 | |
DSP-0378 | Dravet syndrome, Lennox-Gastaut syndrome | Japan | Phase 1 | |
DSP-2342 | To be determined | U.S. | Phase 1 | |
Regenerative medicine / cell therapy | CT1-DAP001/ DSP-1083 (Allogeneic iPS [induced pluripotent stem] cell-derived dopaminergic neural progenitor cells) |
Parkinson’s disease | Japan | Phase 1/2 (Investigator-initiated study) |
U.S. | Phase 1/2 (Investigator-initiated study) |
|||
HLCR011 (Allogeneic iPS cell-derived retinal pigment epithelial cells) |
Retinal pigment epithelium tear | Japan | Phase 1/2 |
Oncology
Brand name/Product code (Generic name) | Proposed indication | Region | Development stage |
---|---|---|---|
TP-3654 | Myelofibrosis | U.S., Japan | Phase 1/2 |
DSP-5336 | Acute leukemia | U.S., Japan | Phase 1/2 |
DSP-0390 | Glioblastoma | U.S., Japan | Phase 1 |
TP-1287 | Solid tumors | U.S. | Phase 1 |
TP-1454 | Solid tumors | U.S. | Phase 1 |
Others
Brand name/Product code (Generic name) | Proposed indication | Region | Development stage |
---|---|---|---|
GEMTESA® (vibegron) |
(New indication) Overactive bladder (OAB) in men with benign prostatic hyperplasia (BPH) | U.S. | Phase 3 |
vibegron | Overactive bladder (OAB) | China | Phase 3 |
SP-101 | Cystic fibrosis | U.S. | Phase 1/2 |
KSP-1007 | Complicated urinary tract infections and Complicated intra-abdominal infections, Hospital-acquired bacterial pneumonia including ventilator-associated bacterial pneumonia | U.S., Japan | Phase 1 |