Profiles of Major Products under Development

New drug candidate compounds under development are listed.

As of May 13, 2026

Psychiatry & Neurology

Small molecule

DSP-0038

Origin in-house (Joint research with Recursion (formerly Exscientia Ltd.))
Formulation oral
Planned indication
  • Alzheimer’s disease psychosis

DSP-0038 is a novel compound discovered at Sumitomo Pharma using Recursion’s AI technologies. DSP-0038 is a serotonin 5-HT2A receptor antagonist and a serotonin 5-HT1A receptor agonist. DSP-0038 is expected to demonstrate a greater antipsychotic effect, based on the additive effect of 5-HT2A receptor antagonist and 5-HT1A receptor agonist. The compound could also have broader efficacy in the treatment of behavioral and psychological symptoms of dementia (BPSD) which include agitation, aggression, anxiety, and depression. Furthermore, DSP-0038 has negligible affinity for dopamine D2 receptors, and therefore it can be expected to show improved safety and tolerability compared to existing antipsychotics.

DSP-0187

Origin in-house
Formulation oral
Planned indication
  • Narcolepsy

DSP-0187 is an orexin 2 receptor agonist. It is expected to improve excessive daytime sleepiness (EDS) and cataplexy of narcolepsy caused by orexin deficiency. DSP-0187 is also expected to demonstrate efficacy in EDS (Excessive Daytime Sleepiness) conditions other than narcolepsy.

DSP-3456

Origin in-house
Formulation oral
Planned indication
  • Treatment resistant depression

DSP-3456 is a metabotropic glutamate receptor 2/3 negative allosteric modulator (mGluR2/3 NAM). DSP-3456 is expected to exhibit a ketamine-like antidepressant effect through selective activation of the prefrontal cortex by enhancing the glutamate release, while avoiding side effects (psychotic symptoms, cognitive dysfunction).

DSP-0378

Origin in-house
Formulation oral
Planned indications
  • Progressive Myoclonic Epilepsy and Developmental Epileptic Encephalopathy

DSP-0378 is a gamma-aminobutyric acid (GABA)A receptor positive allosteric modulator. DSP-0378 acts on various subtypes of GABAA receptors expressed in synaptic and extrasynaptic regions in a manner different from common GABAA receptor potentiators such as benzodiazepines and neurosteroids. DSP-0378 is expected to exhibit an antiepileptic effect against broad epilepsies including Progressive Myoclonic Epilepsy and Developmental Epileptic Encephalopathy.

DSP-2342

Origin in-house (Joint research with Recursion (formerly Exscientia Ltd.))
Formulation oral
Planned indication
  • TBD

DSP-2342 is a novel compound discovered at Sumitomo Pharma using Recursion’s AI technologies. DSP-2342 is a serotonin 5-HT2A and 5-HT7 receptor antagonist. DSP-2342 is expected to demonstrate a broader antipsychotic effect in psychosis, anxiety, and depression, based on the additive effect of 5-HT2A and 5-HT7 receptor antagonist. Furthermore, DSP-2342 has high selectivity for 5-HT2A and 5-HT7 receptors, so is expected to show a high level of safety and tolerability.

DSP-0551

Origin in-house
Formulation oral
Planned indication
  • Tremor associated with Parkinson’s disease

DSP-0551 is a multi-ion channel modulator identified through phenotype-based drug discovery and exhibits inhibitory activity against multiple T‑type calcium and sodium ion channels that have been implicated in tremor. Through these mechanisms, DSP-0551 is expected to modulate abnormal neuronal firing and excessive synchronization in neural circuits associated with tremor, thereby improving tremor associated with Parkinson’s disease.

Regenerative medicine / cell therapy (Collaboration with RACTHERA Co., Ltd.)

In collaboration with RACTHERA Co., Ltd., and our partners in the industry-academia collaboration, we are developing allogeneic iPS cell-derived products using iPS cells from healthy donors for the treatment of Parkinson's disease, RPE (retinal pigment epithelium) tear, AMD (age-related macular degeneration), retinitis pigmentosa, and spinal cord injury.

CT1-DAP001/DSP-1083 (Allogeneic iPS cell-derived dopaminergic neural progenitor cells)

Partnering Kyoto University CiRA, UC San Diego
Planned indication
  • Parkinson’s disease
    In Japan, the Ministry of Health, Labour and Welfare (MHLW) granted CT1-DAP001/DSP-1083 “Sakigake Designation Scheme” status as a regenerative medicine & cell therapy in February 2017 and Orphan Regenerative Medical Product Designation in December 2025 for the indication of Parkinson's disease. In addition, CT1‑DAP001/DSP‑1083 obtained manufacturing and marketing approval in Japan under the conditional and time‑limited approval framework in March 2026.
    In the U.S., an investigator‑initiated clinical study is being conducted at the UC San Diego, while company‑sponsored studies are also being pursued in parallel.

HLCR011 (Allogeneic iPS cell-derived retinal pigment epithelial cells)

Partnering HEALIOS K.K.
Planned indication
  • Retinal pigment epithelium tear

DSP-3077 (Allogeneic iPS cell-derived retinal sheet)

Partnering Massachusetts Eye and Ear in Boston, Massachusetts (Teaching hospital of Harvard Medical School), USA
Planned indication
  • Retinitis pigmentosa

The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for the indication of retinitis pigmentosa in March 2026.

Oncology

Enzomenib

Origin in-house (Joint research with Kyoto University)
Formulation oral
Planned indication
  • Acute leukemia
  • Enzomenib (DSP-5336) is a small molecule inhibitor of the menin and lysine methyltransferase 2A (KMT2A) protein interaction. Acute myeloid leukemia with KMT2A rearrangement or nucleophosmin 1 (NPM1) mutation relies on the menin-KMT2A interaction for upregulation of genes instrumental to leukemogenesis. Enzomenib has been shown to have anti-cancer activity through downregulation of these genes by inhibition of menin-KMT2A interaction in preclinical studies. The FDA granted Orphan Drug Designation for enzomenib for the indication of acute myeloid leukemia in June 2022 and granted Fast Track Designation for the treatment of relapsed or refractory acute myeloid leukemia with KMT2A rearrangement or NPM1 mutation in June 2024. Furthermore, the MHLW granted Orphan Drug Designation for enzomenib for the indication of relapsed or refractory acute myeloid leukemia with KMT2A rearrangement or NPM1 mutation in September 2024.

Nuvisertib

Origin in-house (former Tolero Pharmaceuticals, Inc.)
Formulation oral
Planned indication
  • Myelofibrosis
  • Nuvisertib (TP-3654) inhibits the inflammatory signaling pathways through inhibition of PIM1 (proviral integration site for Moloney murine leukemia virus 1) kinase. PIM1 kinase is frequently overexpressed in various hematologic malignancies and solid tumors, allowing cancer cells to evade apoptosis and promoting tumor growth. The FDA, the MHLW, and the European Medicines Agency (EMA) granted Orphan Drug Designation for nuvisertib for the indication of myelofibrosis in May 2022, November 2024, and July 2025, respectively. Additionally, the FDA granted nuvisertib Fast Track Designation in June 2025, also for the indication of myelofibrosis.

SMP-3124

Origin in-house
Formulation injection (Liposomal Nanomedicine)
Planned indication
  • Solid tumors
  • SMP-3124 is an injection including a liposome encapsulated CHK1 (checkpoint kinase 1) inhibitor. CHK1 is activated by the DNA damage response, leading to cell-cycle arrest, and DNA repair via serine-threonine kinase. CHK1 inhibition leads cancer cells with high replication stress to apoptosis by inducing further DNA damage. SMP-3124 is expected to strengthen the anti-tumor activity and attenuate side effects of the CHK1 inhibitor by changing pharmacokinetics of the compound with liposomal nanomedicinal encapsulation.

DSP-0390

Origin in-house
Formulation oral
Planned indication
  • Glioblastoma
  • DSP-0390 is an inhibitor of Emopamil Binding Protein (EBP), an endoplasmic reticulum membrane protein involved in cholesterol biosynthesis. EBP mediates de novo cholesterol synthesis for cell membrane structure and signaling, enabling aberrant growth of tumors. Inhibition of EBP causes depletion of cellular cholesterol, which is expected to lead to anti-cancer activity. The FDA granted Orphan Drug Designation for DSP-0390 for the indication of brain cancer in May 2022.

Others

KSP-1007

Origin in-house (Joint research with The Kitasato Institute)
Formulation injection
Planned indications
  • Complicated urinary tract and intra-abdominal infections, hospital-acquired bacterial pneumonia including ventilator-associated bacterial pneumonia
  • KSP-1007 broadly and strongly inhibits β-lactamases, enzymes produced by bacteria that can degrade carbapenem antibiotics. KSP-1007 is expected to become an effective treatment option against carbapenem-resistant bacterial infections as a component of a combination drug with meropenem hydrate, a carbapenem antibiotic in general use worldwide (name of Sumitomo Pharma’s product for the Japanese market: MEROPEN®). The FDA granted Qualified Infectious Disease Product (QIDP) status and Fast Track Designation for KSP-1007 for the indications of complicated urinary tract infections, complicated intra-abdominal infections, and hospital-acquired bacterial pneumonia including ventilator-associated bacterial pneumonia in August 2022.

fH1/DSP-0546LP

Origin in-house (Joint research with the National Institutes of Biomedical Innovation, Health and Nutrition)
Formulation injection
Planned indication
  • Influenza virus prophylaxis
  • fH1/DSP-0546LP is a next-generation candidate vaccine formulation composed of the post-fusion hemagglutinin antigen (fH1) that is expected to be effective against a broad range of influenza viruses, and TLR7 adjuvant “DSP-0546LP” that enhances the quantity, quality, and durability of immune responses. Conventional influenza vaccines lose effectiveness due to viral mutations, making it necessary to select, produce, and inoculate a vaccine to immunize against strains predicted to circulate each year. They may also not respond well to emerging strains of influenza. The pre-clinical study of fH1/DSP-0546LP demonstrated broad cross protection against influenza viruses antigenically different from those used in vaccine formulations, and the significance of the TLR7 adjuvant, DSP-0546LP. It is expected that fH1/DSP-0546LP will improve the breadth and durability of protection against seasonal influenza viruses and will be effective against novel and potentially pandemic strains.