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Development Pipeline

Development Pipeline (as of October 27, 2016)

Psychiatry & Neurology Area
Brand name/
Product code
Generic name Proposed indication Development
location
Phase
1
Phase
2
Phase
3
Submitted
APTIOM® eslicarbazepine
acetate
(New indication) Epilepsy-Monotherapy Canada  
LONASEN® blonanserin Schizophrenia China  
(Addition of pediatric usage) Schizophrenia Japan  
(New formulation: Transdermal patch) Schizophrenia Japan    
LATUDA®
(SM-13496)
lurasidone
hydrochloride
Schizophrenia China  
Schizophrenia Japan
Bipolar I depression, Bipolar maintenance Japan  
EPI-743 vatiquinone Leigh syndrome Japan *1  
SEP-225289 dasotraline Adult attention-deficit hyperactivity disorder (ADHD) U.S.  
Pediatric attention-deficit hyperactivity disorder (ADHD) U.S. *2  
Binge eating disorder (BED) U.S. *2  
APL-130277 apomorphine
hydrochloride
OFF episodes associated with Parkinson's disease U.S.  
TRERIEF® zonisamide (New indication) Parkinsonism in Dementia with Lewy Bodies (DLB) Japan  
EPI-589 TBD Parkinson disease U.S.  
Amyotrophic lateral sclerosis (ALS) U.S.  
SEP-363856 TBD Schizophrenia U.S.  
Parkinson's disease psychosis U.S.  
Schizophrenia Japan  
DSP-2230 TBD Neuropathic pain U.K. / U.S. / Japan  
DSP-3748 TBD Cognitive Impairment Associated with Schizophrenia U.S.  
DSP-1200 TBD Treatment-resistant depression U.S.  

*1 A Phase 2 / 3 study completed, development strategy under consideration
*2 Phase 2 / 3 study

Oncology Area (napabucasin, amcasertib)
Brand name/
Product code
Generic name Proposed indication Development
location
Phase
1
Phase
2
Phase
3
Submitted
BBI608 napabucasin Gastric and Gastro-esophageal junction adenocarcinoma (Combination therapy) (Global clinical trial) U.S. / Canada / Japan, etc.  
Colorectal cancer (Combination therapy) (Global clinical trial) U.S. / Japan  
Non-small cell lung cancer (Combination therapy) (Global clinical trial) U.S.  
Colorectal cancer (Combination therapy) U.S. / Canada  
Solid tumors (Ovarian cancer, Breast cancer, Melanoma, etc.) (Combination therapy) U.S. / Canada *1  
Malignant pleural mesothelioma (Combination therapy) Japan *1  
Solid tumors (Combination therapy) *3
Hematologic malignancies (Monotherapy / Combination therapy) 
U.S. / Canada    
Solid tumors (Combination therapy)*4 Japan    
BBI503 amcasertib Solid tumors (Colorectal cancer, Head and Neck cancer, Ovarian cancer, etc.) (Monotherapy) U.S. / Canada *1  
Solid tumors (Renal cell carcinoma, Urothelial carcinoma, Hepatocellular carcinoma, Cholangiocarcinoma, etc.) (Monotherapy) Canada  
Ovarian Cancer (Monotherapy) U.S.  
Hepatocellular carcinoma (Combination therapy) U.S. *2  
Solid tumors (Combination therapy) U.S. / Canada    
Solid tumors (Monotherapy), Hepatocellular carcinoma (Combination therapy) Japan  
BBI608+BBI503 napabucasin
amcasertib
Solid tumors (Combination therapy) U.S.    

*1 Phase 2 of Phase 1 / 2 study
*2 Phase 1 of Phase 1 / 2 study
*3 Multiple studies for different tumor types (Gastrointestinal cancer , Hepatocellular carcinoma, Glioblastoma, Pancreatic cancer)
*4 Multiple studies for different tumor types (Hepatocellular carcinoma)

Oncology Area (Excluding napabucasin, amcasertib)
Brand name/
Product code
Generic name Proposed indication Development
location
Phase
1
Phase
2
Phase
3
Submitted
DSP-7888 TBD Myelodysplastic syndromes Japan *1  
Pediatric malignant gliomas Japan *1  
Solid tumors, Hematologic malignancies U.S.  
WT4869 TBD Myelodysplastic syndromes Japan *2  
Solid tumors Japan  
WT2725 TBD Solid tumors, Hematologic malignancies U.S.  
Solid tumors Japan  
DSP-1958 *3 Thiotepa Conditioning treatment prior to hematopoietic cell transplantation(HPCT) Japan  

*1 Phase 2 of Phase 1 / 2 study
*2 Phase 1 of Phase 1 / 2 study
*3 Development for the use of unapproved or off-labeled drugs

Respiratory Area
Brand name/
Product code
Generic name Proposed indication Development
location
Phase
1
Phase
2
Phase
3
Submitted
SUN-101 glycopyrronium bromide Chronic obstructive pulmonary disease (COPD) U.S.  
Other Areas
Brand name/
Product code
Generic name Proposed indication Development
location
Phase
1
Phase
2
Phase
3
Submitted
DSP-1747 obeticholic acid Nonalcoholic steatohepatitis (NASH) Japan  
DSP-6952 TBD IBS with constipation, Chronic idiopathic constipation Japan  

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