Development Pipeline

Development Pipeline (as of July 29, 2021)

Psychiatry & Neurology

Brand name/
Product code
(Generic name)
Proposed indication Region Development stage
SEP-363856
(ulotaront)
Schizophrenia U.S. Phase 3
Japan, China Phase 2/3
(Global clinical study)
Parkinson’s disease psychosis U.S. Phase 2
LATUDA®
(lurasidone hydrochloride)
(New indication) Bipolar I depression China Phase 3
(New usage: pediatric) Schizophrenia Japan Phase 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 Alzheimer's disease agitation U.S. Phase 1
DSP-1181 Obsessive compulsive disorder Japan Phase 1
DSP-0038 Alzheimer's disease psychosis U.S. Phase 1

Oncology

Brand name/
Product code
(Generic name)
Proposed indication Region Development stage
relugolix Prostate cancer Europe MAA submitted in March 2021
DSP-7888
(adegramotide/
nelatimotide)
Glioblastoma U.S., Japan Phase 3
(Global clinical study)
Solid tumors U.S. Phase 1/2
TP-0903
(dubermatinib)
Acute myeloid leukemia (AML) U.S. Phase 1/2
(Research group- initiated clinical study)
DSP-0509
(guretolimod)
Solid tumors
U.S. Phase 1/2
TP-0184
(itacnosertib)
Anemia associated
with myelodysplastic syndromes
U.S. Phase 1/2
DSP-5336 Hematologic malignancies U.S. Phase 1/2
TP-1287 Solid tumors U.S. Phase 1
TP-3654 Myelofibrosis
U.S. Phase 1
TP-1454 Solid tumors
U.S. Phase 1
DSP-0390 Solid tumors
U.S., Japan 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
BLA resubmitted in April 2021
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
MYFEMBREE®
(relugolix)
(New indication) Endometriosis U.S. sNDA submitted in July 2021
lefamulin Bacterial community-acquired pneumonia China Phase 3
GEMTESA®
(vibegron)
(New indication) Overactive bladder (OAB) in men with benign prostatic hyperplasia (BPH) U.S. Phase 3
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)