As of July 31, 2023
Psychiatry & Neurology
Small molecule
ulotaront（SEP-363856）
| Origin |
in-house (Joint research with former Sunovion Pharmaceuticals Inc. and PsychoGenics Inc.) |
| Formulation |
oral |
| Development stage |
Co-development with Otsuka Pharmaceutical Co., Ltd.
- Schizophrenia: Phase 3 in the U.S.
- Schizophrenia: Phase 2/3 in Japan and China
- Adjunctive major depressive disorder (aMDD): Phase 2/3 in the U.S.
- Generalized anxiety disorder (GAD): Phase 2/3 in the U.S. and Japan
- Parkinson’s disease psychosis: Phase 2 in the U.S.
|
Ulotaront (SEP-363856) is a TAAR1 (trace amine-associated receptor 1) agonist with serotonin 5-HT1A agonist activity. Ulotaront does not bind to dopamine D2 or serotonin 5-HT2A receptors. Former Sunovion discovered ulotaront in collaboration with PsychoGenics using its in vivo phenotypic SmartCube® platform and associated artificial intelligence algorithms. Phase 2 results in patients with an acute exacerbation of schizophrenia support the efficacy of ulotaront in treating both positive and negative symptoms of schizophrenia, with a side effect profile similar to placebo. Notably, ulotaront was not associated with extrapyramidal symptoms, weight gain, changes in lipids or glucose, prolactin elevation. The Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for ulotaront for the indication of schizophrenia in May 2019.
SEP-4199
| Origin |
in-house (former Sunovion Pharmaceuticals Inc.) |
| Formulation |
oral |
| Development stage |
Co-development with Otsuka Pharmaceutical Co., Ltd.
- Bipolar I depression: Phase 3 in the U.S. and Japan
|
SEP-4199 is a non-racemic ratio of amisulpride enantiomers. Former Sunovion discovered that the pharmacology of amisulpride is enantiomer-specific, and that increasing the ratio of R-amisulpride to S-amisulpride increases the potency for serotonin 5-HT7 receptors relative to dopamine D2 receptors. SEP-4199 was discovered with an 85:15 ratio of R-amisulpride to S-amisulpride to increase levels of serotonin 5-HT7 activity intended to enhance antidepressant efficacy and produce reduced levels of D2 receptor occupancy appropriate for the treatment of bipolar depression.
EPI-589
| Origin |
PTC Therapeutics, Inc.(Acquired from BioElectron Technology Corporation) |
| Formulation |
oral |
| Development stage |
- Parkinson’s disease: Phase 2 in the U.S.
- Amyotrophic lateral sclerosis (ALS): Phase 2 in the U.S.
- Amyotrophic lateral sclerosis (ALS): Phase 2 (Investigator-initiated study, Sponsor: Tokushima University) in Japan
|
EPI-589 is expected to show efficacy by removing the oxidative stress that is generated excessively by decreased mitochondrial function. It is expected to be developed for neurodegenerative indications arising through redox stress.
DSP-3905
| Origin |
in-house |
| Formulation |
oral |
| Development stage |
- Neuropathic pain: Phase 1 in the U.S.
|
DSP-3905 is an agent that selectively inhibits voltage-gated sodium channels Nav1.7. Based on its inhibitory mode of action, the agent is expected to show a potent analgesic effect on the pain occurring when neurons get excessively excited. In addition, DSP-3905 has a high selectivity for Nav1.7 expressed in peripheral neuron and may not produce central nervous system or cardiovascular system side effects, which are present with the current drugs for neuropathic pain.
SEP-378614
| Origin |
in-house (Joint research with former Sunovion Pharmaceuticals Inc. and PsychoGenics Inc.) |
| Formulation |
oral |
| Development stage |
Co-development with Otsuka Pharmaceutical Co., Ltd.
|
SEP-378614 is a novel CNS-active molecule. Former Sunovion discovered SEP-378614 in collaboration with PsychoGenics using its in vivo phenotypic SmartCube® platform and associated artificial intelligence algorithms. Pre-clinical studies suggest that it may have rapid onset antidepressant-like activity
SEP-380135
| Origin |
in-house (Joint research with former Sunovion Pharmaceuticals Inc. and PsychoGenics Inc.) |
| Formulation |
oral |
| Development stage |
Co-development with Otsuka Pharmaceutical Co., Ltd.
|
SEP-380135 is a novel CNS-active molecule. Former Sunovion discovered SEP-380135 in collaboration with PsychoGenics using its in vivo phenotypic SmartCube® platform and associated artificial intelligence algorithms. Pre-clinical studies showed a broad range of in vivo activities suggesting efficacy against a number of behavioral and psychological symptoms in dementia, including agitation/aggression, psychomotor hyperactivity and depression.
DSP-0038
| Origin |
in-house (Joint research with Exscientia Ltd.) |
| Formulation |
oral |
| Development stage |
- Alzheimer’s disease psychosis: Phase 1 in the U.S.
|
DSP-0038 is a novel compound discovered at Sumitomo Pharma using Exscientia’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 a 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 antipsychotic.
DSP-9632P
| Origin |
in-house |
| Formulation |
patch |
| Development stage |
- Levodopa-induced dyskinesia in Parkinson’s disease: Phase 1 in Japan
|
DSP-9632P is a serotonin 5-HT1A receptor partial agonist. It is expected to exert an effect on dyskinesia expressed after administration of levodopa by suppressing the excessive release of levodopa-derived dopamine. Pre-clinical studies suggest DSP-9632P suppresses the dyskinesia symptom induced by levodopa. The transdermal patch formulation of DSP-9632P could potentially have an effective treatment option for levodopa-induced dyskinesia in Parkinson's disease by showing stable blood concentration, and may also lead to improved convenience for patients in terms of drug administration.
DSP-0187
| Origin |
in-house |
| Formulation |
oral |
| Development stage |
- Narcolepsy: Phase 1 in Japan
|
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 an efficacy for EDS other than narcolepsy. Sumitomo Pharma granted Jazz Pharmaceuticals plc the exclusive development and commercialization rights in the territories, except for Japan, China, and certain other Asia/Pacific markets in April 2022.
DSP-3456
| Origin |
in-house |
| Formulation |
oral |
| Development stage |
- Treatment resistant depression: Phase 1 in the U.S.
|
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 |
| Development stage |
- Dravet syndrome and Lennox-Gastaut syndrome: Phase 1 in Japan
|
DSP-0378 is a gamma-aminobutyric acid (GABA) A receptor positive allosteric modulator. It 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. It is expected to exhibit an antiepileptic effect against broad epilepsies including intractable rare diseases like Dravet syndrome and Lennox-Gastaut syndrome.
DSP-2342
| Origin |
in-house (Joint research with Exscientia Ltd.) |
| Formulation |
oral |
| Development stage |
|
DSP-2342 is a novel compound discovered at Sumitomo Pharma using Exscientia'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 which includes 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, which can be expected to show a high level of safety and tolerability.
Regenerative medicine / cell therapy
In cooperation with the partners in the industry-academia collaboration, we are developing regenerative medicine / cell therapy using allogeneic iPS (induced pluripotent stem) cell (healthy patients) for RPE (retinal pigment epithelium) tear, AMD (age-related macular degeneration), Parkinson’s disease, retinitis pigmentosa, and spinal cord injury.
CT1-DAP001/DSP-1083 (Allogeneic iPS cell-derived products)
| Partnering |
Kyoto University CiRA |
| Development stage |
- Parkinson’s disease: Phase 1/2 (Investigator-initiated study, Sponsor: Kyoto University Hospital) in Japan
- Parkinson’s disease: Preparing the start of clinical study in the U.S.
|
The Ministry of Health, Labour and Welfare (MHLW) designated “Sakigake Designation System” product for regenerative medicine & cell therapy for the indication of Parkinson's disease in February 2017.
HLCR011 (Allogeneic iPS cell-derived products)
| Partnering |
RIKEN, Healios |
| Development stage |
- Retinal pigment epithelium tear: Phase 1/2 in Japan
|
Oncology
TP-3654
| Origin |
in-house (former Tolero Pharmaceuticals, Inc.) |
| Formulation |
oral |
| Development stage |
- Myelofibrosis: Phase 1/2 in the U.S. and Japan
|
- TP-3654 inhibits the inflammatory signaling pathways through inhibition of PIM (proviral integration site for Moloney murine leukemia virus) kinases. PIM kinases are frequently overexpressed in various hematologic malignancies and solid tumors, allowing cancer cells to evade apoptosis and promoting tumor growth. The FDA granted Orphan Drug Designation for TP-3654 for the indication of myelofibrosis in May 2022.
DSP-5336
| Origin |
in-house (Joint research with Kyoto University) |
| Formulation |
oral |
| Development stage |
- Acute leukemia: Phase 1/2 in the U.S. and Japan
|
- DSP-5336 is a small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein. Acute leukemia with MLL rearrangements or nucleophosmin 1 (NPM1) mutations rely on the menin-MLL interaction for upregulation of genes instrumental to leukemogenesis. DSP-5336 has been shown to have anti-cancer activity through downregulation of the genes by inhibition of meninMLL interaction in pre-clinical studies. The FDA granted Orphan Drug Designation for DSP-5336 for the indication of acute myeloid leukemia in June 2022.
DSP-0390
| Origin |
in-house |
| Formulation |
oral |
| Development stage |
- Glioblastoma: Phase 1 in the U.S. and Japan
|
- DSP-0390 is an inhibitor of Emopamil Binding Protein (EBP), which is one of cholesterol biosynthetic enzymes. EBP is an endoplastic reticulum membrane protein involved in cholesterol biosynthesis. When functional, EBP mediates de novo cholesterol synthesis for cell membrane structure and signaling, enabling aberrant growth of tumors. Inhibition of EBP causes an efficient cellular cholesterol depletion and it is expected to show anti-cancer activities. The FDA granted Orphan Drug Designation for DSP-0390 for the indication of brain cancer in May 2022.
TP-1287
| Origin |
in-house (former Tolero Pharmaceuticals, Inc.) |
| Formulation |
oral |
| Development stage |
- Solid tumors: Phase 1 in the U.S.
|
- TP-1287 is a small molecule oral agent that inhibits cyclin-dependent kinase 9 (CDK9). TP-1287 has shown favorable oral bioavailability in pre-clinical studies. It is enzymatically cleaved, yielding alvocidib, a potent inhibitor of CDK9. The oral administration of TP-1287 may allow for administration for a prolonged period, which may lead to a continuous inhibition of CDK9. The FDA granted Rare Pediatric Disease Designation and Orphan Drug Designation for TP-1287 for the indication of ewing sarcoma in February and March 2023, respectively.
TP-1454
| Origin |
in-house (former Tolero Pharmaceuticals, Inc.) |
| Formulation |
oral |
| Development stage |
- Solid tumors: Phase 1 in the U.S.
|
- TP-1454 inhibits tumor growth through activation of PKM2 (pyruvate kinase M2) which leads to the inhibition of tumor cell proliferation and enhances antitumor immune response in tumor microenvironment. TP-1454 induces the activity of PKM2 through tetramerization of the enzyme which mainly exists in enzymatically less active dimer state in cancer cells. Tetramerization of PKM2 leads to the reduction of aerobic glycolysis in cancer cells and reverts the immunosuppressive microenvironment. TP-1454 is expected to show synergistic effect with immune checkpoint inhibitor.
Others
GEMTESA® (vibegron)
| Origin |
Merck Sharp & Dohme Corp. |
| Formulation |
oral |
| Development stage |
- (New indication) Overactive bladder in men with BPH: Phase 3 in the U.S.
- Overactive bladder: Phase 3 in China
|
- Vibegron is an oral, once-daily, small molecule β3 adrenergic receptor agonist. Vibegron selectively acts on the β3 adrenergic receptor in the bladder that relaxes the bladder, enhances urinary storage, and improves symptoms of urgency, urinary frequency, and urge urinary incontinence in patients with overactive bladder. Urovant has received approval for overactive bladder in the U.S. in December 2020.
lefamulin
| Origin |
Nabriva Therapeutics plc |
| Formulation |
oral, injection |
| Development stage |
- Bacterial community-acquired pneumonia: NDA submitted in China in October 2021
|
- Lefamulin is an antimicrobial agent of pleuromutilin class and a novel treatment for infectious diseases with a mechanism of action that differs from existing antibiotics. Lefamulin is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. Lefamulin’s binding occurs with high affinity, high specificity and at molecular sites that are distinct from other antibiotic classes.
Lefamulin has been marketed by Nabriva Therapeutics in the U.S. since 2019.
SP-101
| Origin |
in-house (Spirovant Sciences, Inc.) |
| Formulation |
Inhalation Suspension |
| Development stage |
- Cystic Fibrosis: Phase 1/2 in the U.S.
|
- SP-101 is a novel adeno-associated viral (AAV) vector engineered to efficiently transduce human airway epithelia from the apical (lumen) surface. It is designed to deliver a shortened but fully functional cystic fibrosis transmembrane conductance regulator (CFTR) gene to the airways of people living with Cystic Fibrosis (CF). Based on preclinical data, the addition of doxorubicin substantially improves SP-101 transduction and subsequent expression of the CFTR gene. SP-101 followed by doxorubicin administered via a nebulizer is being developed as a combination product for the treatment of CF. SP-101 is expected to restore CFTR function and halting disease progression in the lungs of people living with CF.
KSP-1007
| Origin |
in-house (Joint research with The Kitasato Institute) |
| Formulation |
injection |
| Development stage |
- Complicated urinary tract infections and Complicated intra-abdominal infections:Phase 1 in the U.S.
|
- KSP-1007 can broadly and strongly inhibit 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 in a combination drug with meropenem hydrate, a carbapenem antibiotic in general use worldwide (name of Sumitomo Pharma’s product for the domestic market: MEROPEN®). The FDA granted Qualified Infectious Disease Product (QIDP) status and Fast Track Designation for KSP-1007 for the indication of complicated urinary tract infections, complicated intra-abdominal infections, hospital-acquired bacterial pneumonia, and ventilator-associated bacterial pneumonia in August 2022.