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Development Pipeline

Development Pipeline (as of May 8, 2014)

Psychiatry & Neurology Field Approved/Preparing for Launch
Brand name/
Product code
Generic name Proposed indication Development
location
Phase
Phase
Phase
submitted
LATUDA®
(SM-13496)
lurasidone
hydrochloride
Schizophrenia Europe*1
Schizophrenia Australia
(New indication) Bipolar I depression Canada
Schizophrenia Taiwan          
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.  
APTIOM®
(SEP-0002093)
eslicarbazepine
acetate
Epilepsy-Adjunctive therapy Canada  
(New indication) Epilepsy-Monotherapy U.S.  
LONASEN® blonanserin Schizophrenia China  
(Addition of pediatric usage) Schizophrenia Japan  
(New formulation: Transdermal patch) Schizophrenia Japan      
AS-3201 ranirestat Diabetic neuropathy Japan  
EPI-743 TBD Leigh syndrome Japan *2  
SEP-225289 TBD Attention-deficit hyperactivity disorder (ADHD) U.S.  
TRERIEF® zonisamide (New indication) Parkinsonism in Dementia with Lewy Bodies (DLB) Japan  
DSP-2230 TBD Neuropathic pain U.K./U.S.  
SEP-363856 TBD Schizophrenia U.S.  

*1 Lurasidone (SM-13496) : Co-development with Takeda Pharmaceutical in Europe
*2 Phase Ⅱ/Ⅲ study

Cancer Field
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(Combination therapy) (Global clinical trial) U.S.    
Colorectal cancer (Combination therapy) U.S./Canada  
Solid cancer (Combination therapy) U.S./Canada *3  
Gastrointestinal cancer
(Combination therapy)
U.S. /Canada        
Gastric cancer
(Combination therapy)
Japan        
WT4869 TBD Myelodysplastic syndromes Japan *4  
Solid cancer Japan  
WT2725 TBD Solid cancer, Hematologic cancer U.S.  
Solid cancer Japan        
BBI503 TBD Solid cancer (Monotherapy) U.S./Canada  

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

*3 Phase Ⅱ of Phase Ⅰ/Ⅱ study
*4 Phase Ⅰ of Phase Ⅰ/Ⅱ study

Respiratory Field
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.  
DSP-3025 TBD Bronchial asthma/Allergic rhinitis Japan  
Cardiovascular/Diabetes Field
Brand name/
Product code
Generic name Proposed indication Development
location
Phase
Phase
Phase
submitted
METGLUCO® metformin hydrochloride (Addition of pediatric usage) Type 2 diabetes Japan  
SUREPOST® repaglinide (New indication) Type 2 diabetes (All combination therapies including DPP-4 inhibitors) Japan  
Other Fields
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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