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Development Pipeline

Development Pipeline (as of January 29, 2015)

Psychiatry & Neurology Area Approved
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 / China  
Bipolar I depression, Bipolar maintenance Japan  
(New indication) Bipolar maintenance U.S. / Europe, etc.  
(New indication) MDD with mixed features U.S. / Europe, etc.  
AS-3201 ranirestat Diabetic neuropathy Japan  
EPI-743 TBD Leigh syndrome Japan *1  
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 Phase Ⅱ/Ⅲ study

Cancer Area
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  
BBI608 TBD Colorectal cancer (Monotherapy)
(Global clinical trial)(Note)
U.S. / Canada / Japan, etc.  
Gastric cancer, Gastro-esophageal junction adenocarcinoma (Combination therapy) (Global clinical trial) U.S. / Canada / Japan, etc.  
Colorectal cancer (Combination therapy) U.S. / Canada  
Solid tumors (Combination therapy) U.S. / Canada *2  
Hepatocellular carcinoma
(Combination therapy)
U.S. *3  
Glioblastoma (Combination therapy) Canada *3  
Malignant pleural mesothelioma
(Combination therapy)
Japan *3  
Gastrointestinal cancer
(Combination therapy)
U.S. / Canada  
Pancreatic cancer
(Combination therapy)
U.S.  
Hematologic malignancies
(Monotherapy / Combination therapy)
U.S.  
Hepatocellular carcinoma
(Combination therapy)
Japan  
BBI503 TBD Solid tumors (Monotherapy) U.S. / Canada *2  
Renal cell carcinoma, Urothelial carcinoma, Hepatocellular carcinoma, Cholangiocarcinoma, Gastrointestinal stromal tumor (Monotherapy) Canada  
Hepatocellular carcinoma
(Combination therapy)
U.S. *3  
Solid tumors (Monotherapy), Hepatocellular carcinoma (Combination therapy) Japan  
WT4869 TBD Myelodysplastic syndromes Japan *3  
Solid tumors Japan  
WT2725 TBD Solid tumors, Hematologic malignancies U.S.  
Solid tumors Japan  

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

*2 Phase Ⅱ of Phase Ⅰ/Ⅱ study
*3 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.  
Cardiovascular/Diabetes Area
Brand name/
Product code
Generic name Proposed indication Development
location
Phase
Phase
Phase
Submitted
SUREPOST® repaglinide (New indication) Type 2 diabetes (Combination therapies including DPP-4 inhibitors) Japan
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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