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
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
relugolix	Prostate cancer (Monotherapy)	U.S.	NDA submitted in April 2020
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/109KB)

Others

Brand name/ Product code (Generic name)	Proposed indication	Region	Development stage
vibegron	Overactive bladder (OAB)	U.S.	NDA submitted in December 2019
	Overactive bladder (OAB) in men with Benign prostatic hyperplasia (BPH)	U.S.	Phase 3
	IBS-associated pain	U.S.	Phase 2
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
rodatristat rthyl	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 diabetic patients)	Type 2 diabetes	Japan	Phase 3 (Co-development with Save Medical)