Profiles of Major Products
under Development

*as of October 30, 2017

LATUDA® (lurasidone hydrochloride) Atypical antipsychotic

  • Developed in-house
  • LATUDA® (lurasidone hydrochloride) is an atypical antipsychotic agent that is believed to have an affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonist effects. In addition, LATUDA is a partial agonist at the serotonin 5-HT1A receptor and has no appreciable affinity for histamine H1 or muscarinic M1 receptors.
  • Approved country and area:
    Schizophrenia2010: U.S., 2012: Canada, 2013: Switzerland, 2014: Europe and Australia,
    2016: Taiwan, Russia, Singapore, Thailand and Hong Kong, 2017: Brazil
    Bipolar I depression  2013: U.S., 2014: Canada, 2017: Russia and Brazil
  • Development stage:
Stage Proposed indication Country, Area Partners
Submitted Schizophrenia Venezuela Daiichi Sankyo
Schizophrenia Turkey In-house
Schizophrenia China
Bipolar I depression Taiwan Standard Chem. & Pharm.
Phase 3 Schizophrenia Japan In-house
Bipolar I depression, Bipolar maintenance Japan
Schizophrenia Korea Bukwang Pharmaceutical

glycopyrronium bromide (SUN-101) Chronic obstructive pulmonary disease (COPD)

  • Developed in-house (Sunovion Pharmaceuticals Inc., from the former Elevation Pharmaceuticals)
  • SUN-101 is a long-acting muscarinic antagonist (LAMA) bronchodilator delivered via the proprietary investigational eFlow® closed system nebulizer. It is a portable, hand-held nebulizer system and is designed to deliver the medication in approximately two to three minutes. A standard jet nebulizer typically takes up to 10 minutes. Currently, there are no LAMAs delivered via nebulizer that are approved by the U.S. Food and Drug Administration (FDA). SUN-101 is a nebulizer delivered LAMA for COPD at the most advanced development stage.
  • Development stage: NDA submitted in the U.S. in July 2016. NDA resubmitted in June 2017.

dasotraline (SEP-225289) Attention-deficit hyperactivity disorder (ADHD), Binge eating disorder (BED)

  • Developed in-house (Sunovion Pharmaceuticals Inc.)
  • SEP-225289 is a dopamine and norepinephrine reuptake inhibitor (DNRI). SEP-225289 has an extended half-life (47-77 hours) that supports the potential for plasma concentrations yielding a continuous therapeutic effect over the 24-hour dosing interval.
  • Development stage:
    Adult and pediatric attention-deficit hyperactivity disorder (ADHD): NDA submitted in the U.S. in August 2017.
    Binge eating disorder (BED): Phase 3 in the U.S.

napabucasin (BBI608) Cancer

  • Developed in-house (Boston Biomedical, Inc.)
  • BBI608 is an orally administered small molecule agent with a novel mechanism of action designed to inhibit cancer stemness pathways by targeting STAT3. By inhibiting pathways involved in the maintenance of cancer stemness, it may provide a new therapeutic option against the challenges in cancer treatment such as treatment resistance, recurrence and metastasis. BBI608 has been shown to inhibit STAT3 pathways, Nanog pathways and β-catenin pathways in the pre-clinical studies.
  • Development stage:
Stage Proposed indication Country, Area Combination products Study number
Phase 3 Colorectal cancer (combination therapy) U.S., Canada, Japan FOLFIRI*3, FOLFIRI*3 + bevacizumab CanStem303C
Pancreatic cancer(combination therapy) U.S., Japan gemcitabine + nab-paclitaxel CanStem111P
Phase 2 Colorectal cancer (combination therapy) U.S., Canada cetuximab, panitumumab, capecitabine 224
Phase 1/2 Solid tumors*1
(combination therapy)
U.S., Canada paclitaxel 201
Malignant pleural mesothelioma*2(combination therapy) Japan cisplatin + pemetrexed D8807005
Hepatocellular carcinoma*2 (combination therapy) U.S. sorafenib HCC-103
Glioblastoma (combination therapy) Canada temozolomide 251
Solid tumors (combination therapy) U.S. ipilimumab, pembrolizumab, nivolumab 201CIT
Gastrointestinal cancer (combination therapy) U.S., Canada FOLFOX*3, FOLFOX*3 + bevacizumab, CAPOX*3, FOLFIRI*3, FOLFIRI*3 + bevacizumab, regorafenib, irinotecan 246
Phase 1 Pancreatic cancer (combination therapy) U.S. gemcitabine + nab-paclitaxel, FOLFIRINOX*3, FOLFIRI*3, irinotecan liposome injection + fluorouracil + leucovorin 118
Hematologic malignancies (monotherapy / combination therapy) U.S. dexamethasone, bortezomib, imatinib, ibrutinib 103HEME
Hepatocellular carcinoma (combination therapy) Japan sorafenib D8808001
Solid tumors (combination therapy) U.S. amcasertib 401-101

*1 Phase 2 : Ovarian cancer, Brest cancer, Melanoma, etc.

*2 Phase 2

*3 FOLFOX: Combination therapy with fluorouracil, leucovorin, oxaliplatin
CAPOX: Combination therapy with capecitabine, oxaliplatin
FOLFIRI: Combination therapy with fluorouracil, leucovorin, irinotecan
FOLFIRINOX: Combination therapy with fluorouracil, leucovorin, irinotecan, oxaliplatin

apomorphine hydrochloride (APL-130277) Parkinson's disease

  • Developed in-house (Sunovion Pharmaceuticals Inc., from former Cynapsus Therapeutics)
  • APL-130277 is a sublingual film formulation of apomorphine, a dopamine agonist, which is the only molecule approved in the United States for acute intermittent treatment of OFF episodes associated with Parkinson's disease. It is designed to rapidly, safely and reliably convert a Parkinson's disease patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine.
  • Development stage: Phase 3 in the U.S.

vatiquinone (EPI-743) Mitochondrial disease

  • In-licensed from BioElectron Technology Corporation (former Edison Pharmaceuticals, Inc.)
  • EPI-743 is expected to show efficacy by removing the oxidative stress which is generated excessively by decreased mitochondrial function. It is expected to be the world's first treatment for mitochondrial diseases, which there is no effective therapy, beginning with Leigh syndrome.
  • Development stage: A Phase 2/3 study for Leigh syndrome in Japan completed, development strategy under consideration

obeticholic acid (DSP-1747) Nonalcoholic steatohepatitis (NASH), Primary biliary cholangitis (PBC)

  • In-licensed from Intercept Pharmaceuticals Inc. (Intercept's product code: INT-747)
  • DSP-1747 is an agonist for farnesoid X receptor (FXR) whose ligand is the primary human bile acid chenodeoxycholic acid, the natural endogenous FXR agonist. The compound is expected to be effective for hepatic dysfunction and hepatic fibrosis associated with an increase of bile acid in the liver.
  • Development stage: Phase 2 in Japan for NASH, Phase 2 for PBC is under consideration.

DSP-6952 IBS with constipation, Chronic idiopathic constipation

  • Developed in-house
  • DSP-6952 is an enterokinetic agent with a high affinity for serotonin 5-HT4 receptor where it has partial agonist effects. DSP-6952 is expected to be effective for IBS with constipation and chronic idiopathic constipation by increasing complete spontaneous bowel movement.
  • Development stage: Phase 2 in Japan

amcasertib (BBI503) Cancer

  • Developed in-house (Boston Biomedical, Inc.)
  • BBI503 is an orally administered small molecule agent with a novel mechanism of action designed to inhibit cancer stemness pathways, including Nanog, by targeting stemness kinases. By inhibiting pathways involved in the maintenance of cancer stemness, it may provide a new therapeutic option against the challenges in cancer treatment such as treatment resistance, recurrence and metastasis. BBI503 has been shown to inhibit multiple kinases in pre-clinical studies.
  • Development stage:
Stage Proposed indication Country, Area Combination products Study number
Phase 2 Hepatocellular carcinoma, Cholangiocarcinoma (monotherapy) Canada - 205b
Gastrointestinal stromal tumor (monotherapy) Canada - 205c
Ovarian cancer (monotherapy) U.S. - 205GYN-M
Phase 1/2 Solid tumors* (monotherapy) U.S., Canada - 101
Hepatocellular carcinoma (combination therapy) U.S. sorafenib HCC-103
Solid tumors (combination therapy) U.S., Canada capecitabine, doxorubicin, nivolumab, pembrolizumab, paclitaxel, sunitinib 201
Phase 1 Solid tumors (monotherapy), Hepatocellular carcinoma (combination therapy) Japan sorafenib DA101003
Solid tumors (combination therapy) U.S. napabucasin 401-101

* Phase 2 : Colorectal cancer, Head and Neck cancer, Ovarian cancer, etc.

SB623 Stroke

  • In-licensed from and co-developed with SanBio, Inc.
  • SB623 is an allogeneic cell product, derived from bone marrow stromal cells isolated from healthy donors. SB623 is expected to be effective for chronic stroke that has no effective treatments available, by promoting regeneration of central nerve cells. Unlike autologous cell therapies that require individualized cell preparation at the clinical site, SB623 production can be scaled up from a single donor's cells, enabling delivery of uniform-quality products to a large number of stroke patients.
  • Development stage: Phase 2 in the U.S.

EPI-589 Neurodegenerative diseases

  • In-licensed from BioElectron Technology Corporation(former Edison Pharmaceuticals, Inc.)
  • EPI-589 is expected to show efficacy by removing the oxidative stress which is generated excessively by decreased mitochondrial function. It is expected to be developed for neurodegenerative indications arising through redox stress.
  • Development stage:
    Parkinson's disease: Phase 2 in the U.S. by BioElectron Technology Corporation
    Amyotrophic lateral sclerosis (ALS): Phase 2 in the U.S. by BioElectron Technology Corporation

SEP-363856 Schizophrenia, Parkinson's disease psychosis

  • Developed in-house (Sunovion Pharmaceuticals Inc.)
  • SEP-363856 is an antipsychotic agent with a novel mechanism of action, and doesn't show affinity to dopamine D2 receptors. The molecular target(s) responsible for the profile of effects is unknown, but may include agonist effects at serotonin 5-HT1A and TAAR1 (trace amine-associated receptor 1) receptors. Results obtained with the preclinical models suggest that SEP-363856 may be able to treat the positive and negative symptoms of schizophrenia as well as Parkinson's disease psychosis. SEP-363856 is expected to have high efficacy in the treatment of schizophrenia and Parkinson's disease psychosis, while improving patients' QOL.
  • Development stage:
    Schizophrenia: Phase 2 in the U.S.
    Parkinson's disease psychosis: Phase 2 in the U.S.
    Schizophrenia: Phase 1 in Japan

alvocidib Cancer

  • In-licensed from Sanofi S.A.
  • Alvocidib is a small molecule inhibitor of cyclin-dependent kinase 9 (CDK9), a member of cyclin-dependent kinase family, which activates transcription of cancer-related genes. The subsequent down-regulation of MCL-1, an anti-apoptotic gene, may be responsible for the potential clinical anti-cancer activity observed with alvocidib.
  • Development stage:
Stage Proposed indication Country, Area Combination products Study number
Phase 2 Acute myeloid leukemia (AML) (combination therapy)
(refractory or relapsed patients)
U.S., Canada, etc. cytarabine, mitoxantrone TPI-ALV-201
Phase 1 Acute myeloid leukemia (AML) (combination therapy)
(newly diagnosed patients)
U.S. cytarabine, daunorubicin TPI-ALV-101

adegramotide/nelatimotide (DSP-7888) Cancer

  • Developed in-house
  • DSP-7888 is a therapeutic cancer peptide vaccine derived from Wilms' tumor gene 1 (WT1) protein. DSP-7888 is a vaccine containing peptides that induces WT1-specific cytotoxic T lymphocytes (CTLs) and helper T cells. DSP-7888 is expected to become a treatment option for patients with various types of hematologic malignancies and solid tumors that express WT1, by inducing WT1-specific CTLs that attack WT1-expressing cancers cells. By adding a helper T cell-inducing peptide, improved efficacy over that observed with a CTL-inducing peptide alone may be achieved. DSP-7888 is expected to be an option for a wide range of patients.
  • Development stage:
Stage Proposed indication Country, Area Combination products Study number
Phase 2 Glioblastoma (combination therapy) U.S., Canada, Japan, etc. bevacizumab BBI-DSP7888-201G
Phase 1/2 Myelodysplastic syndromes (MDS) * (monotherapy) Japan - DB650027
Pediatric malignant gliomas * (monotherapy) Japan - DB601001
Phase 1 Solid tumors, Hematologic malignancies (monotherapy) U.S., Canada - BBI-DSP7888-101
Solid tumors (combination therapy) U.S. nivolumab, atezolizumab BBI-DSP7888-102CI

* Phase 2

WT4869 Cancer

  • Developed in-house (Joint research with Chugai Pharmaceutical Co., Ltd.)
  • WT4869 is a therapeutic cancer peptide vaccine derived from Wilms' tumor gene 1 (WT1) protein. WT4869 is expected to treat various types of hematologic malignancies and solid tumors that express WT1, by inducing WT1-specific cytotoxic T-lymphocytes that attack WT1-expressing cancer cells.
  • Development stage:
    Myelodysplastic syndromes (MDS)(Monotherapy): Phase 1/2 in Japan
    Solid tumors (Monotherapy): Phase 1 in Japan

WT2725 Cancer

  • Developed in-house (Joint research with Chugai Pharmaceutical Co., Ltd.)
  • WT2725 is a therapeutic cancer peptide vaccine derived from Wilms' tumor gene 1 (WT1) protein. WT2725 is expected to treat various types of hematologic malignancies and solid tumors that express WT1, by inducing WT1-specific cytotoxic T-lymphocytes that attack WT1-expressing cancerous cells.
  • Development stage:
    Solid tumors, Hematologic malignancies (Monotherapy): Phase 1 in the U.S.
    Solid tumors (Monotherapy): Phase 1 in Japan

DSP-2230 Neuropathic pain

  • Developed in-house
  • DSP-2230 is an agent that selectively inhibits voltage-gated sodium channels Nav1.7 and Nav1.8 with higher potencies than those against the other sodium channel subtypes studied. In addition, DSP-2230 has demonstrated antiallodynic effects in preclinical models of neuropathic pain that have been shown to be predictive of efficacy in humans. Due to its novel mechanism, DSP-2230 is expected not to produce central nervous system or cardiovascular system side effects, which are present with the current drugs, such as non-selective sodium channel blockers and anti-epilepsy medicines.
  • Development stage: Phase 1 in the U.K., U.S. and Japan

DSP-6745 Parkinson's disease psychosis

  • Developed in-house
  • DSP-6745 is a serotonin 5-HT2A and serotonin 5-HT2C receptors dual antagonist, which is expected to be effective for Parkinson's disease psychosis and one or more Parkinson's disease non-motor symptoms (depression, anxiety, or cognitive impairment). In addition, DSP-6745 has negligible affinity for dopamine D2 receptors.
  • Development stage: Phase 1 in the U.S.

TP-0903 Cancer

  • Developed in-house (Tolero Pharmaceuticals, Inc.)
  • TP-0903 is an AXL receptor tyrosine kinase inhibitor, which is known to be involved in acquiring resistance to conventional agents and developing metastatic capacity in cancer cells. TP-0903 may have anti-cancer effects on various cancer types through blocking transition from epithelial to mesenchymal phenotype by inhibiting AXL. TP0903 has been shown to inhibit AXL signaling and reverse the mesenchymal to epithelial phenotype in pre-clinical studies.
  • Development stage:
    Solid tumors (Monotherapy): Phase 1 in the U.S.

SEP-378608 Bipolar disorder

  • Developed in-house
  • SEP-378608 is a novel CNS-active molecule discovered using preclinical models phenotypic screening platform. Pre-clinical studies suggest that it may modulate neuronal activity in key areas of brain associated with the regulation of mood.
  • Development stage:
    Bipolar disorder: Phase 1 in the U.S.