Development Pipeline
Development Pipeline (as of October 28, 2020)
Psychiatry & Neurology
Brand name/ Product code (Generic name) |
Proposed indication | Region | Development stage |
---|---|---|---|
LONASEN® (blonanserin) |
(New usage: pediatric) Schizophrenia | Japan | NDA submitted in May 2020 |
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) (Monotherapy/Combination therapy) (Refractory or relapsed patients) |
U.S. | Phase 2 |
Myelodysplastic syndromes (MDS) (Combination therapy) |
U.S. | Phase1/2 | |
DSP-7888 (adegramotide/ nelatimotide) |
Glioblastoma (Combination therapy) | U.S., Japan | Phase 2 (Global clinical study) |
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/109KB)
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. | NDA submitted in May 2020 | ||
Endometriosis | U.S. | Phase 3 (Global clinical study) | |
PXL008 (imeglimin) |
Type 2 diabetes | Japan | NDA submitted in July 2020 |
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 |
Frontier business
Brand name/ Product code (Generic name) |
Proposed indication | Region | Development stage |
---|---|---|---|
SMC-01 (mobile app for management of diabetic patients) |
Type 2 diabetes | Japan | Phase 3 (Co-development with Save Medical) |