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 October 31, 2023
Psychiatry & Neurology
| Brand name/Product code (Generic name) | Proposed indication | Region | Development stage | |
|---|---|---|---|---|
| Small molecule | SEP-363856 (ulotaront) |
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-9632P | Levodopa-induced dyskinesia in Parkinson's disease | Japan | 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 dopamine neural progenitor cells) |
Parkinson’s disease | Japan | Phase 1/2 (Investigator-initiated study) |
| U.S. | Preparing the start of clinical 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 |
|---|---|---|---|
| lefamulin | Bacterial community-acquired pneumonia | China | NDA submitted in October 2021 |
| 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 | U.S. | Phase 1 |