Development Pipeline

Development Pipeline (as of May 11, 2017)

Psychiatry & Neurology Area

Brand
name/
Product
code
Generic nameProposed indicationDevelopment locationPhaseSubmitted
123
APTIOM® eslicarbazepine
acetate
(New indication) Epilepsy-Monotherapy Canada
(New usage:pediatric) Epilepsy (Monotherapy / Adjunctive therapy) U.S.
LONASEN® blonanserin (New usage:pediatric) 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.  
Binge eating disorder (BED) U.S.  
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-1200 TBD Treatment-resistant depression U.S.
DSP-6745 TBD Parkinson's disease psychosis U.S.

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

Oncology Area (napabucasin, amcasertib)

Brand
name/
Product
code
Generic nameProposed indicationDevelopment locationPhaseSubmitted
123
BBI608 napabucasin Gastric and Gastro-esophageal junction adenocarcinoma (Combination therapy) (Global clinical study) U.S. / Canada / Japan, etc.
Colorectal cancer (Combination therapy)(Global clinical study) U.S. / Canada / Japan, etc.
Non-small cell lung cancer (Combination therapy) (Global clinical study) U.S.
Pancreatic cancer (Combination therapy) (Global clinical study) U.S.
Colorectal cancer (Combination therapy) U.S. / Canada
Solid tumors (Ovarian cancer, Breast cancer, Melanoma, Glioblastoma, etc.) (Combination therapy)*3 U.S. / Canada *1
Malignant pleural mesothelioma (Combination therapy) Japan *1
Solid tumors (Combination therapy) *4
Hematologic malignancies (Monotherapy / Combination therapy)
U.S. / Canada*5
Hepatocellular carcinoma (Combination therapy) 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 Glioblastoma's development is only Canada.
*4 Multiple studies for different tumor types (Gastrointestinal cancer , Hepatocellular carcinoma, Glioblastoma, Pancreatic cancer)
*5 Clinical study conducted in Canada is only for gastrointestinal cancer

Oncology Area (Excluding napabucasin, amcasertib)

Brand
name/
Product
code
Generic nameProposed indicationDevelopment locationPhaseSubmitted
123
DSP-7888 TBD Myelodysplastic syndromes (Monotherapy) Japan *1
Pediatric malignant gliomas (Monotherapy) Japan *1
Glioblastoma (Combinatnion therapy) U.S.  
Solid tumors, Hematologic malignancies (Monotherapy) U.S. / Canada
WT4869 TBD Myelodysplastic syndromes (Monotherapy) Japan *2
Solid tumors (Monotherapy) Japan
WT2725 TBD Solid tumors, Hematologic malignancies (Monotherapy) U.S.
Solid tumors (Monotherapy) Japan
DSP-1958 *3 thiotepa Conditioning treatment prior to hematopoietic cell transplantation (HPCT)(Monotherapy) Japan
alvocidib alvocidib Acute myeloid leukemia (AML)(Combination therapy / Biomarker-driven) U.S.
TP-0903 TBD Solid tumors (Monotherapy) U.S.

*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 nameProposed indicationDevelopment locationPhaseSubmitted
123
SUN-101 glycopyrronium bromide Chronic obstructive pulmonary disease (COPD) U.S.

Other Areas

Brand
name/
Product
code
Generic nameProposed indicationDevelopment locationPhaseSubmitted
123
DSP-1747 obeticholic acid Nonalcoholic steatohepatitis (NASH) Japan
DSP-6952 TBD IBS with constipation, Chronic idiopathic constipation Japan