Development Pipeline

Development Pipeline (as of May 13, 2020)

Psychiatry & Neurology

Brand name/
Product code
(Generic name)
Proposed indication Region Development stage
APL-130277
(apomorphine hydrochloride)
OFF episodes associated with Parkinson’s disease U.S. NDA submitted in March 2018
Received Complete Response Letter in January 2019
NDA resubmitted in November 2019
LONASEN®
(blonanserin)
(New usage: pediatric) Schizophrenia Japan 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
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)
(Combination therapy)
(Refractory or relapsed patients)
U.S. Phase 2
Myelodysplastic syndromes (MDS)
(Combination therapy)
U.S. Phase1/2
Acute myeloid leukemia (AML)
(Combination therapy)
(Newly diagnosed patients)
U.S. Phase 1
DSP-7888
(adegramotide/
nelatimotide)
Glioblastoma (Combination therapy) U.S., Japan Phase 2
(Global clinical study)
Pediatric malignant gliomas
(Monotherapy)
Japan Phase 1/2
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
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. Phase 3 (Global clinical study)
Endometriosis U.S. Phase 3 (Global clinical study)
PXL008
(imeglimin)
Type 2 diabetes Japan Phase 3
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