Development Pipeline

Psychiatry & Neurology

Brand name/ Product code (Generic name)	Proposed indication	Region	Development stage
LONASEN® (blonanserin)	(New usage: pediatric) Schizophrenia	Japan	NDA submitted in May 2020
LATUDA® (lurasidone hydrochloride)	(New indication) Bipolar I depression	China	Phase 3
SEP-363856	Schizophrenia	U.S.	Phase 3
		Japan	Phase 1
	Parkinson’s disease psychosis	U.S.	Phase 2
EPI-743 (vatiquinone)	Leigh syndrome	Japan	Phase 2/3
EPI-589	Parkinson’s disease	U.S.	Phase 2
	Amyotrophic lateral sclerosis (ALS)	U.S.	Phase 2
		Japan	Phase 1
SEP-4199	Bipolar l depression	U.S., Japan	Phase 2 (Global clinical study)
DSP-6745	Parkinson’s disease psychosis	U.S.	Phase 1
SEP-378608	Bipolar disorder	U.S.	Phase 1
DSP-3905	Neuropathic pain	U.S.	Phase 1
SEP-378614	Treatment resistant depression	U.S.	Phase 1
SEP-380135	Agitation in Alzheimer's disease	U.S.	Phase 1
DSP-1181	Obsessive compulsive disorder	Japan	Phase 1

Oncology

Brand name/ Product code (Generic name)	Proposed indication	Region	Development stage
BBI608 (napabucasin)	Colorectal cancer (Combination therapy)	U.S., Japan	Phase 3 (Global clinical study)
	Hepatocellular carcinoma (Combination therapy)	U.S.	Phase 1/2
	Gastrointestinal cancer (Combination therapy)	U.S.	Phase 1/2
	Solid tumors (Combination therapy)	U.S.	Phase 1/2
DSP-2033 （alvocidib）	Acute myeloid leukemia (AML) (Monotherapy/Combination therapy) (Refractory or relapsed patients)	U.S.	Phase 2
	Myelodysplastic syndromes (MDS) (Combination therapy)	U.S.	Phase1/2
DSP-7888 （adegramotide/ nelatimotide）	Glioblastoma (Combination therapy)	U.S., Japan	Phase 2 (Global clinical study)
	Solid tumors (Combination therapy)	U.S.	Phase 1/2
TP-0903 (dubermatinib)	Solid tumors (Monotherapy / Combination therapy)	U.S., Japan	Phase 1
DSP-0509	Solid tumors (Monotherapy / Combination therapy)	U.S.	Phase 1/2
TP-0184	Anemia associated with myelodysplastic syndromes (Monotherapy)	U.S.	Phase 1/2
	Solid tumors (Monotherapy)	U.S.	Phase 1
DSP-0337	Solid tumors (Monotherapy)	U.S.	Phase 1
TP-1287	Solid tumors (Monotherapy)	U.S.	Phase 1
TP-3654	Solid tumors (Monotherapy)	U.S.	Phase 1
	Myelofibrosis (Monotherapy / Combination therapy)	U.S.	Phase 1
TP-1454	Solid tumors (Monotherapy / Combination therapy)	U.S.	Phase 1

Regenerative medicine / cell therapy

Brand name/ Product code (Generic name)	Proposed indication	Region	Development stage
RVT-802	Pediatric congenital athymia	U.S.	BLA submitted in April 2019 Received Complete Response Letter in December 2019
Allo iPS cell-derived dopamine neural progenitor	Parkinson’s disease	Japan	Phase 1/2 (Investigator-initiated clinical study)
HLCR011 (Allo iPS cell-derived retinal pigment epithelium)	Age-related macular degeneration (AMD)	Japan	Preparing for start of clinical study

Regenerative Medicine/Cell Therapy Business Plan (PDF/110KB)

Others

Brand name/ Product code (Generic name)	Proposed indication	Region	Development stage
relugolix	Uterine fibroids	Europe	MAA submitted in March 2020
		U.S.	NDA submitted in May 2020
	Endometriosis	U.S.	Phase 3 (Global clinical study)
PXL008 （imeglimin）	Type 2 diabetes	Japan	NDA submitted in July 2020
GEMTESA® (vibegron)	(New indication) Overactive bladder (OAB) in men with benign prostatic hyperplasia (BPH)	U.S.	Phase3
rodatristat ethyl	Pulmonary arterial hypertension (PAH)	U.S.	Phase 2
MVT-602	Female infertility	Germany	Phase 2
URO-902	Overactive bladder (OAB)	U.S.	Phase 2

Frontier business

Brand name/ Product code (Generic name)	Proposed indication	Region	Development stage
SMC-01 (mobile app for management of type 2 diabetic patients)	Type 2 diabetes	Japan	Phase 3 (Co-development with Save Medical)