Development Pipeline

Key clinical studies our Group is conducting in respect of the indications for which we are pursuing approvals in Japan, USA 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 May 13, 2025

Psychiatry & Neurology

Brand name/Generic name/Product code Proposed indication Region Development stage
Small molecule
LATUDA®/lurasidone hydrochloride (New usage: pediatric) Schizophrenia Japan Phase 3
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 Progressive Myoclonic Epilepsy and Developmental Epileptic Encephalopathy Japan Phase 1
DSP-2342 To be determined U.S. Phase 1
Regenerative medicine / cell therapy
(Collaboration with RACTHERA Co., Ltd.) 		CT1-DAP001/DSP-1083
(Allogeneic iPS [induced pluripotent stem] cell-derived dopaminergic neural progenitor cells)		 Parkinson’s disease Japan Under preparation for the NDA
U.S. Phase 1/2
(Investigator-initiated study)
Phase 1/2
(Company-sponsored clinical study)
HLCR011
(Allogeneic iPS cell-derived retinal pigment epithelial cells)		 Retinal pigment epithelium tear Japan Phase 1/2
DSP-3077
（Allogeneic iPS cell-derived retinal sheet）		 Retinitis pigmentosa U.S. Phase 1/2

Oncology

Brand name/Generic name/Product code Proposed indication Region Development stage
enzomenib/DSP-5336 Acute myeloid leukemia U.S., Japan Phase 2
nuvisertib/TP-3654 Myelofibrosis U.S., Japan Phase 1/2
DSP-0390 Glioblastoma U.S., Japan Phase 1
SMP-3124 Solid tumors U.S., Japan Phase 1/2

Others

Brand name/Generic name/Product code Proposed indication Region Development stage
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
fH1/DSP-0546LP Influenza Europe Phase 1