Phase 1
Phase 2
Phase 3
Application
Therapeutic
area
Cardiovascular-
Metabolics
Oncology
Others
Edoxaban (JP)
(DU-176b / AF / FXa inhibitor)
Prasugrel (JP)
(CS-747 / Ischemic stroke / Anti-
platelet agent)
Esaxerenone (JP)
(CS-3150 / Hypertension /
MR antagonist)
Edoxaban (ASCA etc.)
(DU-176b / AF / FXa inhibitor)
Edoxaban (ASCA etc.)
(DU-176b / VTE / FXa inhibitor)
Tivantinib (US/EU)
(ARQ 197 / HCC / MET inhibitor)
Denosumab (JP)
(AMG 162 / Breast cancer adjuvant /
Anti-RANKL antibody)
Nimotuzumab (JP)
(DE-766 / Gastric cancer / Anti-EGFR
antibody)
Vemurafenib (US/EU)
(PLX4032 / Melanoma Adjuvant / BRAF
inhibitor)
Quizartinib (US/EU/Asia)
(AC220 / AML-2
nd
/ FLT3-ITD inhibitor)
Quizartinib (US/EU/Asia)
(AC220 / AML-1
st
/ FLT3-ITD inhibitor)
Pexidartinib (US/EU)
(PLX3397 / TGCT / CSF-1R/KIT/FLT3-ITD
inhibitor)
Laninamivir (US/EU)
(CS-8958 / Anti-influenza /
out-licensing with Biota)
Mirogabalin (US/EU)
(DS-5565 / Fibromyalgia / α2δ ligand)
Mirogabalin (JP/Asia)
(DS-5565 / DPNP/ α2δ ligand)
Mirogabalin (JP/Asia)
(DS-5565 / PHN / α2δ ligand)
Hydromorphone (JP)
(DS-7113 / Cancer pain / Opioid μ-
receptor regulator)
CHS-0214 (JP)
(Etanercept BS / Rheumatoid
arthritis / TNFα inhibitor)
VN-0105 (JP)
(DPT-IPV / Hib vaccine)
Laninamivir (JP)
(CS-8958 / Anti-influenza / nebulizer)
Esaxerenone (JP)
(CS-3150 / DM nephropathy / MR
antagonist)
DS-8500 (JP/US)
(Diabetes / GPR119 agonist)
Patritumab (EU)
(U3-1287 / Anti-HER3 antibody)
Pexidartinib (US)
(PLX3397 / CSF-1R/KIT/FLT3-ITD
inhibitor)
DS-1647 (JP)
(Glioblastoma / G47Δ virus)
DS-1040
(Acute ischemic stroke / TAFIa inhibitor)
DS-2330
(Hyperphosphatemia)
DS-9231/TS23
(Thrombosis / α2-PI inactivating antibody)
DS-9001
(Dyslipidemia / Anti-PCSK9 Anticalin-Albumod)
DS-3032 (US/JP)
(MDM2 inhibitor)
PLX7486 (US)
(FMS / TRK inhibitor)
PLX8394 (US)
(BRAF inhibitor)
DS-6051 (US/JP)
(NTRK/ROS1 inhibitor)
PLX9486 (US)
(KIT inhibitor)
DS-3201 (JP)
(EZH1/2 inhibitor)
PLX73086 (US)
(CSF-1R inhibitor)
PLX51107 (US)
(BRD4 inhibitor)
DS-1971
(Chronic pain)
DS-1501
(Osteoporosis / Anti-Siglec-15 antibody)
DS-7080 (US)
(AMD / Angiogenesis inhibitor)
DS-2969
(
Clostridium difficile
infection
/GyrB inhibitor)
DS-5141 (JP)
(DMD / ENA oligonucleotide)
VN-0102/JVC-001 (JP)
(MMR vaccine)
Hydromorphone (JP)
(DS-7113 / Cancer pain / Opioid μ-
receptor agonist)
CL-108 (US)
(Acute pain / Opioid μ-receptor
agonist)
Intradermal Seasonal
Influenza Vaccine (JP)
(VN-100 / prefilled i.d. vaccine for
seasonal flu)
VN-0107/MEDI3250 (JP)
(Nasal spray flu vaccine)
Denosumab (JP)
(AMG 162 / Rheumatoid arthritis /
Anti-RANKL antibody)
Major R&D Pipeline
DS-8895 (JP)
(Anti-EPHA2 antibody)
DS-8273 (US)
(Anti-DR5 antibody)
DS-5573 (JP)
(Anti-B7-H3 antibody)
DS-8201 (JP/US)
(Anti-HER2 ADC)
U3-1784 (EU)
(Anti-FGFR4 antibody)
DS-1123 (JP)
(Anti-FGFR2 antibody)
U3-1402 (JP)
(Anti-HER3 ADC)
As of January 2017
Red: Major changes after the FY2016 Q2 financial announcement on October 31, 2016
11. Major R&D Pipeline (Innovative pharmaceuticals
）
◆
Oncology (Late-stage pipeline products)
Generic Name/Project Code Number
(Brand Name)
Class
Target indication
Region Stage
Dosage
Form
Partner
Target FY for
approval/launch
Anti-RANKL antibody
Breast cancer adjuvant
JP
P3 Injection
Amgen
2020
BRAF inhibitor
Melanoma adjuvant
US/EU
P3
Oral
–
–
MET inhibitor
Hepatocellular cancer
US/EU
P3
Oral
ArQule, Inc.
2018
US/EU/Asia P3
2018
US/EU/Asia P3
2021-
JP
P1
–
Tenosynovial Giant Cell Tumor (TGCT)
US/EU
P3
2019
Solid tumor
Asia
P1
–
Glioblastoma
US
P2
–
c-KIT Melanoma
Asia
P1/2
–
Melanoma, solid tumor
US
P1/2
Merck & Co., Inc.
–
Anti-EGFR antibody
Gastric cancer
JP
P3 Injection InnoClMAb Pte Ltd
2020
Anti-HER3 antibody
Head & neck cancer
EU
P2 Injection
–
–
Oncolytic HSV-1
Glioblastoma
JP
P2 Injection
ActiVec Inc.
–
Remarks
Denosumab/AMG 162
Ranmark (JP)
Additional indication
The fully human monoclonal antibody to target RANK Ligand, an essential mediator of osteoclast formation.
Vemurafenib/PLX4032
Zelboraf
Additional indication. Licensee Roche is conducting the
study. Submission in 2017 is planned.
The molecular-targeted agent to inhibit BRAF V600E mutation.
Tivantinib/ARQ 197
HCC with MET high patients
The molecular-targeted agent to inhibit HGF(hepatocyte growth factor) receptor, MET which has multiple roles in intracellular signal transductions such as cancer cell proliferation, angiogenesis, invasion, and apoptosis
induction.
Nimotuzumab/DE-766
Patritumab/U3-1287
Pexidartinib/PLX3397
CSF-1R/KIT/FLT3-ITD inhibitor
Oral
–
Quizartinib/AC220
FLT3-ITD inhibitor
Acute myeloid leukemia
Oral
–
Relapsed and refractory AML patients
Newly diagnosed AML patients
Kinase inhibitor against a receptor-type tyrosine kinase, FLT3. Therapeutic effect for patients with acute myeloid leukemia harboring FLT3-ITD mutation is expected.
DS-1647(G47
D
)
Received SAKIGAKE Designation from MHLW
Investigator Initiated Study is on-going
The third generation oncolytic herpes simplex virus type 1(HSV-1), ghenetically-engineered to restrict virus replication to tumor cells. This oncolytic virus therapy is expected equal or better safety and better efficacy profile
compare to existing oncolytic virus.
Underline: change after FY2016 Q2 Financial Announcement in October 2016
As of January 2017
The humanized monoclonal antibody to target Epidermal Growth Factor Receptor(EGFR). This antibody is expected to be a best in class EGFR, safety against the skin toxicity and the efficacy comparable to the other
antibodies.
The fully human monoclonal antibody to target HER3, one of the Epidermal Growth Factor Receptor (EGFR) family of proteins. HER 3 is overexpressed in many tumors of epithelial origin and HER2/HER3 dimers and
EGFR/HER3 dimers are expected more potent to induce tumor cell proliferation than homodimers of HER2 or EGFR.
Including pigmented villonodular synovitis
Including TGCT
Combination with pembrolizumab in collaboration with
Merck
The molecular-targeted agent to inhibit CSF-1R, KIT and FLT3-ITD. This agent is expected to reduce tumor cell proliferation and expansion of metastases.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!