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 30, 2024
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 | 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 | Under preparation for the NDA |
| U.S. | Phase 1/2 (Investigator-initiated study) |
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| Phase 1/2 (Company-sponsored clinical study) |
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| HLCR011 (Allogeneic iPS cell-derived retinal pigment epithelial cells) |
Retinal pigment epithelium tear | Japan | Phase 1/2 | |
Oncology
| Brand name/Generic name/Product code | Proposed indication | Region | Development stage |
|---|---|---|---|
| nuvisertib/TP-3654 | Myelofibrosis | U.S., Japan | Phase 1/2 |
| enzomenib/DSP-5336 | Acute myeloid leukemia | 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 |
|---|---|---|---|
| GEMTESA®/vibegron | (New indication) Overactive bladder (OAB) in men with benign prostatic hyperplasia (BPH) | U.S. | sNDA submitted in February 2024 |
| vibegron | Overactive bladder (OAB) | China | Phase 3 |
| 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 |