Development Pipeline

Development Pipeline (as of October 31, 2022)

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 study)
Adjunctive major depressive disorder (aMDD) U.S. Phase 2/3
Parkinson’s disease psychosis U.S. Phase 2
SEP-4199 Bipolar l depression U.S., Japan Phase 3
(Global study)
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 2
(Investigator-initiated study)
SEP-378608 Bipolar disorder U.S. Phase 1
DSP-3905 Neuropathic pain U.S. Phase 1
SEP-378614 To be determined U.S. Phase 1
SEP-380135 To be determined U.S. Phase 1
DSP-0038 Alzheimer's disease psychosis U.S. Phase 1
DSP-9632P Levodopa-induced dyskinesia in Parkinson's disease Japan Phase 1
DSP-0187 Narcolepsy Japan Phase 1
DSP-3456 Treatment resistant depression U.S. Phase 1
DSP-0378 Dravet syndrome, Lennox-Gastaut syndrome Japan Phase 1

Oncology

Brand name/
Product code
(Generic name)
Proposed indication Region Development stage
DSP-0509
(guretolimod)
Solid tumors
U.S., Japan Phase 1/2
DSP-5336 Acute leukemia U.S., Japan Phase 1/2
TP-1287 Solid tumors U.S. Phase 1
TP-3654 Myelofibrosis
U.S., Japan Phase 1/2
TP-1454 Solid tumors
U.S. Phase 1
DSP-0390 Glioblastoma
U.S., Japan Phase 1

Regenerative medicine / cell therapy

Brand name/
Product code
(Generic name)
Proposed indication Region Development stage
CT1-DAP001/DSP-1083
(Allo iPS cell-derived dopamine neural progenitor)
Parkinson's disease Japan Phase 1/2
(Investigator-initiated study)
U.S. Preparing to start of clinical study
HLCR011
(Allo iPS cell-derived retinal pigment epithelium)
Age-related macular degeneration (AMD) Japan Preparing to start of clinical study

Others

Brand name/
Product code
(Generic name)
Proposed indication Region Development stage
lefamulin Bacterial community-acquired pneumonia China NDA submitted in October 2021
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
KSP-1007 Complicated urinary tract infections and Complicated intra-abdominal infections U.S. Phase 1

Frontier business

Development Status of Major Programs (PDF/95KB)