Development Pipeline
Development Pipeline (as of July 29, 2019)
Psychiatry & Neurology
| Brand name/ Product code (Generic name) |
Proposed indication | Region | Development stage |
|---|---|---|---|
| SM-13496 (lurasidone hydrochloride) |
Schizophrenia | Japan | Phase 3 |
| Bipolar l depression | Japan | Phase 3 | |
| SEP-225289 (dasotraline) |
Binge eating disorder (BED) | U.S. | Submitted in May 2019 |
| Attention-deficit hyperactivity disorder (ADHD) | U.S. | Submitted in August 2017 Received Complete Response Letter in August 2018 |
|
| Japan | Phase 1 | ||
| APL-130277 (apomorphine hydrochloride) |
OFF episodes associated with Parkinson’s disease | U.S. | Submitted in March 2018 Received Complete Response Letter in January 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 1 |
| 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 |
Oncology
| Brand name/ Product code (Generic name) |
Proposed indication | Region | Development stage |
|---|---|---|---|
| RETHIO® (thiotepa) |
(New indication) Conditioning Treatment Prior to Autologous Hematopoietic Stem Cell Transplantation (HSCT) for malignant lymphoma * Development for the use of unapproved or off-labeled drugs |
Japan | Submitted in March 2019 |
| 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 | |
| BBI503 （amcasertib） |
Hepatocellular carcinoma (Combination therapy) |
U.S. | Phase 1/2 |
| Solid tumors (Monotherapy/ 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 | |
| Acute myeloid leukemia (AML) (Combination therapy) (Newly diagnosed and refractory or relapsed patients) |
Japan | Phase 1 | |
| DSP-7888 （adegramotide/ nelatimotide） |
Glioblastoma (Combination therapy) | U.S., Japan | Phase 2 (Global clinical study) |
| Myelodysplastic syndromes (MDS) (Monotherapy) |
Japan | Phase 1/2 | |
| Pediatric malignant gliomas (Monotherapy) |
Japan | Phase 1/2 | |
| Solid tumors, Hematologic malignancies (Monotherapy) | U.S. | Phase 1 | |
| Solid tumors (Combination therapy) | U.S. | Phase 1 | |
| BBI608+BBI503 (napabucasin+amcasertib) |
Solid tumors (Combination therapy) | U.S. | Phase 1 |
| TP-0903 | Chronic lymphocytic leukemia (CLL) (Monotherapy / Combination therapy) |
U.S. | Phase1/2 |
| Solid tumors (Monotherapy / Combination therapy) |
U.S., Japan | Phase 1 | |
| DSP-0509 | Solid tumors (Monotherapy) | U.S. | Phase 1 |
| TP-0184 | 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 |
Regenerative medicine / cell therapy
| Brand name/ Product code (Generic name) |
Proposed indication | Region | Development stage |
|---|---|---|---|
| SB623 | Chronic stroke | U.S. | Phase 2 |
| 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 38KB)
Others
| Brand name/ Product code (Generic name) |
Proposed indication | Region | Development stage |
|---|---|---|---|
| PXL008 （imeglimin） |
Type 2 diabetes | Japan | Phase 3 |