Development Pipeline

Development Pipeline (as of January 28, 2021)

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

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)