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 |
Regenerative Medicine/Cell Therapy Business Plan (PDF/105KB)
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 |