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Development Pipeline

Development Pipeline (as of May 11, 2015)

Psychiatry & Neurology Area
Brand name/
Product code
Generic name Proposed indication Development
location
Phase
Phase
Phase
Submitted
APTIOM®
(SEP-0002093)
eslicarbazepine
acetate
(New indication) Epilepsy-Monotherapy U.S. / Canada  
LONASEN® blonanserin Schizophrenia China  
(Addition of pediatric usage) Schizophrenia Japan  
(New formulation: Transdermal patch) Schizophrenia Japan    
LATUDA®
(SM-13496)
lurasidone
hydrochloride
Schizophrenia Japan*1 / China  
Bipolar I depression, Bipolar maintenance Japan  
(New indication) Bipolar maintenance U.S. / Europe, etc.  
AS-3201 ranirestat Diabetic neuropathy Japan  
EPI-743 TBD Leigh syndrome Japan *2  
SEP-225289 dasotraline Adult attention-deficit hyperactivity disorder (ADHD) U.S.  
Pediatric attention-deficit hyperactivity disorder (ADHD) U.S.  
TRERIEF® zonisamide (New indication) Parkinsonism in Dementia with Lewy Bodies (DLB) Japan  
SB623 TBD Chronic stroke U.S.  
DSP-2230 TBD Neuropathic pain U.K. / U.S.  
SEP-363856 TBD Schizophrenia U.S.  
DSP-3748 TBD Cognitive Impairment Associated with Schizophrenia U.S.  

*1 A Phase III study completed, development policy under consideration
*2 Phase II / III study

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

Note: Further enrollment of new patients was stopped and all patients discontinued study therapy in May 2014.

*1 Phase II of Phase I / II study
*2 Phase I of Phase I / II study
*3 A number of tumor type-specific studies (Gastrointestinal cancer , Hepatocellular carcinoma, Glioblastoma, Pancreatic cancer)
*4 A number of tumor type-specific studies (Malignant pleural mesothelioma, Hepatocellular carcinoma)

Oncology Area (Excluding BBI608, BBI503)
Brand name/
Product code
Generic name Proposed indication Development
location
Phase
Phase
Phase
Submitted
CALSED®
(Brand name in Japan)
amrubicin
hydrochloride
Small cell lung cancer China  
WT4869 TBD Myelodysplastic syndromes Japan *1  
Solid tumors Japan  
WT2725 TBD Solid tumors, Hematologic malignancies U.S.  
Solid tumors Japan  
DSP-7888 TBD Myelodysplastic syndromes Japan *1  

*1 Phase I of Phase I / II study

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

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