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