Development Pipeline

Here are the key clinical studies in indications for which the Sumitomo Pharma Group aims to obtain approval. The study for the most advanced development stage is listed if there are multiple studies with the same region and indication.

As of October 31, 2025

Drug Candidates in Development

  • Psychiatry & Neurology
    (Small molecule)     Number of compounds under development

    0

  • Psychiatry & Neurology
    （Regenerative medicine / cell therapy）     Number of programs
     

    0

  • Oncology
          Number of compounds under development

    0

  • Others
          Number of compounds under development

    0

Psychiatry & Neurology

Brand name/Generic name/Product code Planned indication(s) Development stage
Small molecule
LATUDA®/lurasidone hydrochloride (New usage: pediatric) Schizophrenia Phase 3
DSP-0038 Alzheimer’s disease psychosis Phase 1
DSP-0187* Narcolepsy Phase 1
DSP-3456 Treatment resistant depression Phase 1
DSP-0378 Progressive Myoclonic Epilepsy
Developmental Epileptic Encephalopathy 		Phase 1
DSP-2342 To be determined 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) (JAPAN) 		Parkinson’s disease
(Investigator-initiated study) 		MAA submitted in August 2025
CT1-DAP001/DSP-1083
(Allogeneic iPS [induced pluripotent stem] cell-derived dopaminergic neural progenitor cells) (U.S.) 		Parkinson’s disease
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 Phase 1/2
DSP-3077
（Allogeneic iPS cell-derived retinal sheet） 		Retinitis pigmentosa Phase 1/2
  • *Development rights: Japan, China, and certain Asian countries

Oncology

Brand name/Generic name/Product code Planned indication(s) Development stage
enzomenib/DSP-5336 Acute leukemia Phase 2
nuvisertib/TP-3654 Myelofibrosis Phase 1/2
SMP-3124 Solid tumors Phase 1/2
DSP-0390 Glioblastoma Phase 1

Others

Brand name/Generic name/Product code Planned indication(s) Development stage
KSP-1007 Complicated urinary tract infections
Complicated intra-abdominal infections
Hospital-acquired bacterial pneumonia including ventilator-associated bacterial pneumonia 		Phase 1
fH1/DSP-0546LP Influenza Phase 1