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 |
Regenerative Medicine/Cell Therapy Business Plan (PDF/109KB)
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) |