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

Others

Brand name/
Product code
(Generic name)
Proposed indication Region Development stage
PXL008
(imeglimin)
Type 2 diabetes Japan Phase 3