Pipeline Chart

* As of January 2017
Therapeutic area Phase 1 Phase 2 Phase 3 Application
Oncology DS-3032
(US/JP)

(MDM2 inhibitor)
Patritumab
(EU)

(U3-1287 / Anti-HER3 antibody)
Tivantinib
(US/EU)

(ARQ 197 / HCC / MET inhibitor)
 
Generic Name Class Target indication Region/Stage
DS-3032 MDM2 inhibitor Solid cancer, lymphoma US/JP P1
Leukemia US P1
Generic Name Class Target indication Region/Stage
Patritumab Anti-HER3 antibody Head & neck cancer EU P2

<Summary>
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.

Generic Name Class Target indication Region/Stage Remarks
Tivantinib MET inhibitor Hepatocellular cancer US/EU P3 HCC with MET high patients

<Summary>
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.

PLX7486
(US)

(FMS / TRK inhibitor)
Pexidartinib
(US)

(PLX3397 / CSF-1R/KIT/FLT3-ITD inhibitor)
Denosumab
(JP)

(AMG 162 / Breast cancer adjuvant / Anti-RANKL antibody)
 
Generic Name Class Target indication Region/Stage
PLX7486 FMS/TRK inhibitor Solid cancer US P1
Generic Name Class Target indication Region/Stage Remarks
Pexidartinib/PLX3397 CSF-1R/KIT/FLT3-ITD inhibitor Glioblastoma US P2  
Solid tumor Asia P1 Including TGCT
c-KIT Melanoma Asia P1/2  
Melanoma, solid tumor US P1/2 Combination with pembrolizumab in collaboration with Merck

<Summary>
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.

Generic Name Class Target indication Region/Stage Remarks
Denosumab
Ranmark (JP)
Anti-RANKL antibody Breast cancer adjuvant JP P3 Additional indication

<Summary>
The fully human monoclonal antibody to target RANK Ligand, an essential mediator of osteoclast formation.

PLX8394
(US)

(BRAF inhibitor)
DS-1647
(JP)

(Glioblastoma / G47Δ virus)
Nimotuzumab
(JP)

(DE-766 / Gastric cancer / Anti-EGFR antibody)
 
Generic Name Class Target indication Region/Stage
PLX8394 BRAF inhibitor Solid cancer, leukemia US P1
Generic Name Class Target indication Region/Stage Remarks
DS-1647(G47Δ) Oncolytic HSV-1 Glioblastoma JP P2 Received SAKIGAKE Designation from MHLW
Investigator Initiated Study is on-going

<Summary>
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.

Generic Name Class Target indication Region/Stage
Nimotuzumab Anti-EGFR antibody Gastric cancer JP P3

<Summary>
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.

DS-6051
(US/JP)

(NTRK/ROS1 inhibitor)
  Vemurafenib
(US/EU)

(PLX4032 / Melanoma Adjuvant / BRAF inhibitor)
 
Generic Name Class Target indication Region/Stage
DS-6051 NTRK/ROS1 inhibitor Solid cancer US/JP P1
Generic Name Class Target indication Region/Stage Remarks
Vemurafenib
Zelboraf
BRAF inhibitor Melanoma adjuvant US/EU P3 Additional indication. Licensee Roche is conducting the study. Submission in 2017 is planned.

<Summary>
The molecular-targeted agent to inhibit BRAF V600E mutation.

PLX9486
(US)

(KIT inhibitor)
  Quizartinib
(US/EU/Asia)

(AC220 / AML-2nd / FLT3-ITD inhibitor)
 
Generic Name Class Target indication Region/Stage
PLX9486 KIT inhibitor Solid cancer US P1
Generic Name Class Target indication Region/Stage Remarks
Quizartinib FLT3-ITD inhibitor Acute myeloid leukemia US/EU/Asia P3 Relapsed and refractory AML patients
US/EU/Asia P3 Newly diagnosed AML patients
JP P1  

<Summary>
Kinase inhibitor against a receptor-type tyrosine kinase, FLT3. Therapeutic effect for patients with acute myeloid leukemia harboring FLT3-ITD mutation is expected.

DS-3201
(JP)

(EZH1/2 inhibitor)
  Quizartinib
(US/EU/Asia)

(AC220 / AML-1st / FLT3-ITD inhibitor)
 
Generic Name Class Target indication Region/Stage
DS-3201 EZH1/2 inhibitor Non-Hodgkin's lymphoma JP P1
Generic Name Class Target indication Region/Stage Remarks
Quizartinib FLT3-ITD inhibitor Acute myeloid leukemia US/EU/Asia P3 Relapsed and refractory AML patients
US/EU/Asia P3 Newly diagnosed AML patients
JP P1  

<Summary>
Kinase inhibitor against a receptor-type tyrosine kinase, FLT3. Therapeutic effect for patients with acute myeloid leukemia harboring FLT3-ITD mutation is expected.

PLX73086
(US)

(CSF-1R inhibitor)
  Pexidartinib
(US/EU)

(PLX3397 / TGCT / CSF-1R/KIT/FLT3-ITD inhibitor)
 
Generic Name Class Target indication Region/Stage
PLX73086/AC708 CSF-1R inhibitor Tenosynovial Giant Cell Tumor (TGCT) US P1
Generic Name Class Target indication Region/Stage Remarks
Pexidartinib/PLX3397 CSF-1R/KIT/FLT3-ITD inhibitor Tenosynovial Giant Cell Tumor (TGCT) US/EU P3 Including pigmented villonodular synovitis

<Summary>
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.

PLX51107
(US)

(BRD4 inhibitor)
     
Generic Name Class Target indication Region/Stage
PLX51107 BRD4 inhibitor Hematologic malignancies US P1
DS-8895
(JP)

(Anti-EPHA2 antibody)
     
Generic Name Class Target indication Region/Stage
DS-8895 Anti-EPHA2 antibody Solid cancer JP P1
DS-8273
(US)

(Anti-DR5 antibody)
     
Generic Name Class Target indication Region/Stage
DS-8273 Anti-DR5 antibody Solid cancer US P1
DS-5573
(JP)

(Anti-B7-H3 antibody)
     
Generic Name Class Target indication Region/Stage
DS-5573 Anti-B7-H3 antibody Solid cancer JP P1
DS-8201
(JP/US)

(Anti-HER2 ADC)
     
Generic Name Class Target indication Region/Stage
DS-8201 Anti-HER2 antibody drug conjugate Solid cancer JP/US P1
U3-1784
(EU)

(Anti-FGFR4 antibody)
     
Generic Name Class Target indication Region/Stage
U3-1784 Anti-FGFR4 antibody Solid cancer EU P1
DS-1123
(JP)

(Anti-FGFR2 antibody)
     
Generic Name Class Target indication Region/Stage
DS-1123 Anti-FGFR2 antibody Solid cancer JP P1
U3-1402
(JP)

(Anti-HER3 ADC)
     
Generic Name Class Target indication Region/Stage
U3-1402 Anti-HER3 antibody drug conjugate Solid cancer JP P1
Cardiovascular-Metabolics DS-1040
(Acute ischemic stroke / TAFIa inhibitor)
Esaxerenone
(JP)

(CS-3150 / DM nephropathy / MR antagonist)
Edoxaban
(JP)

(DU-176b / AF / FXa inhibitor)
Edoxaban
(ASCA etc.)

(DU-176b / AF / FXa inhibitor)
Generic Name Class Target indication Region/Stage
DS-1040 TAFIa inhibitor Acute ischemic stroke - P1
Generic Name Class Target indication Region/Stage
Esaxerenone/CS-3150 MR antagonist Diabetic nephropathy JP P2b

<Summary>
The agent inhibits aldosterone binding to Mineralocorticoid Receptor(MR) which stimulate the sodium absorption into kidney. This agent is expected antihypertensive and organ-protective effect.

Generic Name Class Target indication Region/Stage Remarks
Edoxaban
Lixiana (JP)
LIXIANA (EU, Asia)
SAVAYSA (US)
Factor Xa inhibitor Elderly patients with non-valvular atrial fibrillation JP P3 Additional dosage and administration for elderly patients

<Summary>
The once daily oral anti coagulant (FXa inhibitor) discovered by Daiichi Sankyo. Edoxaban specifically, reversibly and directly inhibits the enzyme, Factor Xa, a clotting factor in the blood.

Generic Name Class Target indication Region/Stage Remarks
Edoxaban
Lixiana (JP)
LIXIANA (EU, Asia)
SAVAYSA (US)
Factor Xa inhibitor Atrial fibrillation (AF) ASCA etc. Submitted BR (14/6*), CN(15/8)
* means June 2014
Approved CA(16/11), TR(16/11), TH(16/12)

<Summary>
The once daily oral anti coagulant (FXa inhibitor) discovered by Daiichi Sankyo. Edoxaban specifically, reversibly and directly inhibits the enzyme, Factor Xa, a clotting factor in the blood.

DS-2330
(Hyperphosphatemia)
DS-8500
(JP/US)

(Diabetes / GPR119 agonist)
Prasugrel
(JP)

(CS-747 / Ischemic stroke / Antiplatelet agent)
Edoxaban
(ASCA etc.)

(DU-176b / VTE / FXa inhibitor)
Generic Name Class Target indication Region/Stage
DS-2330 Hyperphosphatemia treatment Hyperphosphatemia in chronic kidney disease (CKD) - P1
Generic Name Class Target indication Region/Stage
DS-8500 GPR119 agonist Diabetes JP/US P2

<Summary>
The agent agonistically acts on GPR119 which is expressed in small intestine and spleen cells. This agent is expected to stimulate insulin secretion, and to lower blood glucose concentration.

Generic Name Class Target indication Region/Stage Remarks
Prasugrel
Effient (US, Asia)
Efient (JP, EU)
Anti-platelet agent Ischemic stroke JP P3 Additional indication, phase 3 studies completed

<Summary>
The oral antiplatelet agent. Prasugrel helps to keep blood platelets from clumping together and developing a blockage in an artery.

Generic Name Class Target indication Region/Stage Remarks
Edoxaban
Lixiana (JP)
LIXIANA (EU, Asia)
SAVAYSA (US)
Factor Xa inhibitor Venous thromboembolism (VTE) ASCA etc. Submitted BR (14/6*), CN(15/8)
* means June 2014
Approved CA(16/11), TR(16/11), TH(16/12)

<Summary>
The once daily oral anti coagulant (FXa inhibitor) discovered by Daiichi Sankyo. Edoxaban specifically, reversibly and directly inhibits the enzyme, Factor Xa, a clotting factor in the blood.

DS-9231/TS23
(Thrombosis / α2-PI inactivating antibody)
  Esaxerenone
(JP)

(CS-3150 / Hypertension / MR antagonist)
 
Generic Name Class Target indication Region/Stage Remarks
DS-9231/TS23 α2 plasmin inhibitor-inactivating antibody Thrombosis
(cardiovascular diseases, ischemic stroke)
- P1 In-licensed from Translational Sciences Inc.
Generic Name Class Target indication Region/Stage
Esaxerenone/CS-3150 MR antagonist Hypertension JP P3

<Summary>
The agent inhibits aldosterone binding to Mineralocorticoid Receptor(MR) which stimulate the sodium absorption into kidney. This agent is expected antihypertensive and organ-protective effect.

DS-9001
(Dyslipidemia / Anti-PCSK9 Anticalin-Albumod)
     
Generic Name Class Target indication Region/Stage Remarks
DS-9001 Anti-PCSK9 Anticalin-Albumod Dyslipidemia - P1 Using technology of Pieris Pharmaceuticals, Inc. and Affibody AB
Others DS-1971
(Chronic pain)
Laninamivir
(US/EU)

(CS-8958 / Anti-influenza / out-licensing with Biota)
Mirogabalin
(US/EU)

(DS-5565 / Fibromyalgia / α2δ ligand)
Hydromorphone
(JP)

(DS-7113 / Cancer pain / Opioid µ-receptor agonist)<Oral>
Generic Name Class Target indication Region/Stage
DS-1971 Analgesic agent Chronic pain - P1
Generic Name Class Target indication Region/Stage Remarks
Laninamivir
Inavir (JP)
Neuraminidase inhibitor Influenza US/EU P2 Out-licensing with Biota

<Summary>
The long-acting neuraminidase inhibitor and acts directly on the pulmonary and tracheal sites of infection.

Generic Name Class Target indication Region/Stage
Mirogabalin α2δ ligand Fibromyalgia US/EU P3

<Summary>
The pain therapy agent to reduce the neurotransmitter release from nerve terminals. This agent is expected to show the good balanced efficacy and safety profile.

Generic Name Class Target indication Region/Stage Remarks
Hydromorphone Opioid μ-receptor agonist Cancer pain JP NDA of oral formulation was submitted in March 2016 by Daiichi Sankyo Propharma
Extended-release and immediate-release formulations

<Summary>
Narcotic analgesics

DS-1501
(Osteoporosis / Anti-Siglec-15 antibody)
  Mirogabalin
(JP/Asia)

(DS-5565 / DPNP/ α2δ ligand)
CL-108
(US)

(Acute pain / Opioid µ-receptor agonist)
Generic Name Class Target indication Region/Stage
DS-1501 Anti-Siglec-15 antibody Osteoporosis US P1
Generic Name Class Target indication Region/Stage
Mirogabalin α2δ ligand Diabetic peripheral neuropathic pain JP/Asia P3

<Summary>
The pain therapy agent to reduce the neurotransmitter release from nerve terminals. This agent is expected to show the good balanced efficacy and safety profile.

Generic Name Class Target indication Region/Stage Remarks
CL-108 Opioid μ-receptor agonist combination Acute pain US NDA was submitted in March 2016 by Charleston Laboratories, Inc., licensor and co-development partner

<Summary>
Combination product of immediate-release promethazine, hydrocodone and acetaminophen. Reduction of opioid-induced nausea and vomiting (OINV) is expected.

DS-7080
(US)

(AMD / Angiogenesis inhibitor)
  Mirogabalin
(JP/Asia)

(DS-5565 / PHN / α2δ ligand)
Intradermal Seasonal
Influenza Vaccine
(JP)

(VN-100 / prefilled i.d. vaccine for seasonal flu)
Generic Name Class Target indication Region/Stage
DS-7080 Angiogenesis inhibitor Neovascular age-related macular degeneration (AMD) US P1
Generic Name Class Target indication Region/Stage
Mirogabalin α2δ ligand Postherpetic neuralgia JP/Asia P3

<Summary>
The pain therapy agent to reduce the neurotransmitter release from nerve terminals. This agent is expected to show the good balanced efficacy and safety profile.

Generic Name Class Target indication Region/Stage Remarks
VN-100 Intradermal Seasonal Influenza Vaccine Prevention of seasonal Influenza JP Submitted by Japan Vaccine in April 2015

<Summary>
The Vaccine is a pre-filled syringe type, intradermal influenza HA vaccine co-developed by four companies [Daiichi Sankyo, Terumo Corporation, Japan Vaccine and Kitasato Daiichi Sankyo Vaccine Co., Ltd.]. The intradermal injection device for this vaccine is developed by Terumo Corpotation. This device, which offers a more easy-to-use, surefire method to administer the vaccine than current methods. The device is also expected to ease patient hesitation to be injected and lower the risk of damaging peripheral blood vessels and nerves within the subcutaneous tissue.

DS-2969
(Clostridium difficile infection /GyrB inhibitor)
  Hydromorphone
(JP)

(DS-7113 / Cancer pain / Opioid µ-receptor regulator) <Injection>
VN-0107/MEDI3250
(JP)

(Nasal spray flu vaccine vaccine)
Generic Name Class Target indication Region/Stage
DS-2969 GyrB inhibitor Clostridium difficile infection (CDI) - P1
Generic Name Class Target indication Region/Stage
Hydromorphone Opioid μ-receptor agonist Cancer pain JP P3

<Summary>
Narcotic analgesics

Generic Name Class Target indication Region/Stage Remarks
VN-0107/MEDI3250 Live attenuated influenza vaccine Prevention of seasonal influenza JP Submitted by Daiichi Sankyo in June 2016

<Summary>
The US brand name of this vaccine is FluMist Quadrivalent that is a live attenuated influenza vaccine which is administered as a nasal spray and contains four protective strains.

DS-5141
(JP)

(DMD / ENA oligonucleotide)
  CHS-0214
(JP)

(Etanercept BS / Rheumatoid arthritis / TNFα inhibitor)
Denosumab
(JP)

(AMG 162 / Rheumatoid arthritis / Anti-RANKL antibody)
Generic Name Class Target indication Region/Stage
DS-5141 ENA oligonucleotide Duchenne muscular dystrophy(DMD) JP P1/2
Generic Name Class Target indication Region/Stage Remarks
CHS-0214 TNFα inhibitor Rheumatoid arthritis JP P3 In preparation for submission

<Summary>
Etanercept biosimilar

Generic Name Class Target indication Region/Stage Remarks
Denosumab
Pralia (JP)
Anti-RANKL antibody Rheumatoid arthritis JP Additional Indication, submitted in Sep 2016

<Summary>
The fully human monoclonal antibody to target RANK Ligand, an essential mediator of osteoclast formation.

VN-0102/JVC-001
(JP)

(MMR vaccine)
  VN-0105
(JP)

(DPT-IPV / Hib vaccine)
 
Generic Name Class Target indication Region/Stage Remarks
VN-0102/JVC-001 Measles-Mumps-Rubela vaccine Prevention of Measles,
Mumps and Rubela
JP P1/2 Japan vaccine company is conducting the phase 1/2 study
Generic Name Class Target indication Region/Stage Remarks
VN-0105 DPT-IPV/Hib vaccine Prevention of pertussis, diphtheria,
tetanus, poliomyelitis and Hib
JP P3 Co-develop with Sanofi K.K.and KDSV

<Summary>
A combination vaccine reconstituting Hib with precipitated and purified pertussis-diphtheria-tetanus-inactivated polio vaccine (Salk vaccine) vaccine launched in Japan, as 1st in the class of pentavalent vaccine (DPT-IPV/Hib).

    Laninamivir
(US/EU)

(CS-8958 / Anti-influenza / nebulizer)
 
Generic Name Class Target indication Region/Stage Remarks
Laninamivir
Inavir (JP)
Neuraminidase inhibitor Influenza JP P3 Additional dosage form, nebulizer formulation

<Summary>
The long-acting neuraminidase inhibitor and acts directly on the pulmonary and tracheal sites of infection.