Pipeline Chart

Therapeutic area Phase 1 Phase 2 Phase 3 Application
Oncology DS-3032
(US/JP)

(MDM2 inhibitor)
Patritumab
(EU)

(U3-1287 / Anti-HER3 antibody)
Denosumab
(JP)

(AMG 162 / Breast cancer adjuvant / Anti-RANKL antibody)
 
Generic Name Class Target indication Region/Stage
DS-3032 MDM2 inhibitor Solid cancer 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. HER3 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
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.

PLX7486
(US)

(FMS / TRK inhibitor)
Pexidartinib
(US/Asia)

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

(DE-766 / Gastric cancer / Anti-EGFR 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 Solid tumor Asia P1 Including TGCT
Glioblastoma US P2  
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
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.

PLX8394
(US)

(BRAF inhibitor)
DS-1647
(JP)

(Glioblastoma / G47Δ virus)
Vemurafenib
(US/EU)

(PLX4032 / Melanoma Adjuvant / BRAF inhibitor)
 
Generic Name Class Target indication Region/Stage
PLX8394 BRAF inhibitor Solid cancer US P1
leukemia US P1
Generic Name Class Target indication Region/Stage Remarks
DS-1647(G47Δ) Oncolytic HSV-1 Glioblastoma JP P2 Granted SAKIGAKE designation from MHLW. Investigator Initiated Study is on-going.
Orphan drug designation from MHLW in July 2017.

<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 Remarks
Vemurafenib
Zelboraf
BRAF inhibitor Melanoma adjuvant US/EU P3 Additional indication. Licensee Roche is conducting the study. Submission in 2018 is planned.

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

DS-6051
(US/JP)

(NTRK/ROS1 inhibitor)
Quizartinib
(JP)

(AC220 / AML-2nd / FLT3-ITD inhibitor)
Quizartinib
(US/EU/Asia)

(AC220 / AML-2nd / FLT3-ITD 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
Quizartinib FLT3-ITD inhibitor Acute myeloid leukemia JP P2 Relapsed and refractory AML patients
Commencement of phase 2 study

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

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

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

PLX9486
(US)

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

(AC220 / AML-1st / 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

<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/US)

(EZH1/2 inhibitor)
  Pexidartinib
(US/EU)

(PLX3397 / TGCT / CSF-1R/KIT/FLT3-ITD inhibitor)
 
Generic Name Class Target indication Region/Stage Remarks
DS-3201 EZH1/2 inhibitor Non-Hodgkin's lymphoma JP P1
Acute myeloid leukemia US P1 Commencement of phase 1 study
Generic Name Class Target indication Region/Stage Remarks
Pexidartinib/PLX3397 CSF-1R/KIT/FLT3-ITD inhibitor Tenosynovial Giant Cell Tumor 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.

PLX73086
(US)

(CSF-1R inhibitor)
     
Generic Name Class Target indication Region/Stage
PLX73086/AC708 CSF-1R inhibitor Tenosynovial Giant Cell Tumor US P1
PLX51107
(US)

(BRD4 inhibitor)
     
Generic Name Class Target indication Region/Stage
PLX51107 BRD4 inhibitor Hematologic malignancies US P1
DS-8273
(US)

(Anti-DR5 antibody)
     
Generic Name Class Target indication Region/Stage
DS-8273 Anti-DR5 antibody Solid cancer US P1
DS-8201
(JP/US)

(Anti-HER2 ADC)
     
Generic Name Class Target indication Region/Stage Remarks
DS-8201 Anti-HER2 antibody drug conjugate Solid cancer JP/US P1 Granted Fast Track designation for HER2-positive metastatic breast cancer by U.S. FDA
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
DS-1001
(JP)

(IDH1m inhibitor)
     
Generic Name Class Target indication Region/Stage Remarks
DS-1001 IDH1 mutant inhibitor Glioma JP P1 Commencement of phase 1 study
Cardiovascular-Metabolics DS-1040
(US/EU/JP)

(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 US/EU/JP 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 (AF) JP P3 Additional dosage and formulation for elderly (80 years and older) AF 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)
  Prasugrel
(JP)

(CS-747 / Ischemic stroke / Anti-platelet 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 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 (Acute pulmonary embolism, 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.

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)<Injection>
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 Remarks
Mirogabalin α2δ ligand Fibromyalgia US/EU P3 Announced top line result

<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 Submitted Injection/Submitted by Daiichi Sankyo Propharma in February 2017
Drug with new route of administration

<Summary>
Narcotic analgesics. Immediate and extended-release tablets were launced in Japan in June 2017.

DS-1501
(US)

(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 of antiemetic Acute pain US FDA issued Complete Response Letter in the end of January 2017

<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 Remarks
Mirogabalin α2δ ligand Postherpetic neuralgia JP/Asia P3 Announced top line result

<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
(US)

(Clostridium difficile infection /GyrB inhibitor)
  VN-0105
(JP)

(DPT-IPV / Hib vaccine)
VN-0107/MEDI3250
(JP)

(Nasal spray flu vaccine)
Generic Name Class Target indication Region/Stage Remarks
DS-2969 GyrB inhibitor Clostridium difficile infection (CDI) - P1 Active in out-licensing
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).

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)
  Laninamivir
(JP)

(CS-8958 / Anti-influenza / nebulizer)
 
Generic Name Class Target indication Region/Stage Remarks
DS-5141 ENA oligonucleotide Duchenne muscular dystrophy(DMD) JP P1/2 Granted SAKIGAKE designation from MHLW in April 2017
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.

VN-0102/JVC-001
(JP)

(MMR 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