Pipeline Chart

* As of April 2018
Therapeutic area Phase 1 Phase 2 Phase 3 Application
Oncology DS-3032
(US/JP)

(MDM2 inhibitor)
Patritumab
(EU)

(U3-1287 / H&N cancer / Anti-HER3 antibody)
Denosumab
(JP)

(AMG 162 / Breast cancer adjuvant / Anti-RANKL antibody)
 
Generic Name Class Target indication Region/Stage Remarks
Milademetan/DS-3032 MDM2 inhibitor Solid tumors US/JP P1
Acute Myeloid Leukemia (AML) US P1
Acute Myeloid Leukemia (AML) US P1 prep Combination with quizartinib
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
Announced TLR in Feb 2018

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

PLX7486
(US)

(FMS / TRK inhibitor)
DS-1647
(JP)

(Glioblastoma / G47Δ virus)
Quizartinib
(US/EU/Asia)

(AC220 / AML-2nd / FLT3 inhibitor)
 
Generic Name Class Target indication Region/Stage
PLX7486 FMS/TRK inhibitor Solid tumors 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), genetically-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
Quizartinib FLT3 inhibitor Acute Myeloid Leukemia (AML) US/EU/Asia P3 Relapsed and refractory 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.

PLX8394
(US)

(BRAF inhibitor)
Quizartinib
(JP)

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

(AC220 / AML-1st / FLT3 inhibitor)
 
Generic Name Class Target indication Region/Stage
PLX8394 BRAF inhibitor Solid tumors US P1
Generic Name Class Target indication Region/Stage Remarks
Quizartinib FLT3 inhibitor Acute Myeloid Leukemia (AML) JP P2 Relapsed and refractory 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.

Generic Name Class Target indication Region/Stage Remarks
Quizartinib FLT3 inhibitor Acute Myeloid Leukemia (AML) 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)
DS-8201
(JP/US/EU)

(Breast cancer/anti-HER2 ADC)
Pexidartinib
(US/EU)

(PLX3397 / TGCT / CSF-1R/KIT/FLT3 inhibitor)
 
Generic Name Class Target indication Region/Stage
PLX9486 KIT inhibitor Solid tumors (gastrointestinal stromal tumor) US P1
Generic Name Class Target indication Region/Stage Remarks
Trastuzumab deruxtecan / DS-8201 Anti-HER2 antibody drug conjugate Breast cancer JP/US/EU/Asia P2 Granted Fast Track Designation for HER2 positive metastatic breast cancer by U.S. FDA
Granted Breakthrough Therapy Designation for HER2 positive locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1) by U.S. FDA

<Summary>
Granted Fast Track designation for HER2 positive metastatic breast cancer by U.S. FDA
The drug (payload) conjugated through linker to the fully human monoclonal antibody to target HER2, one of the Epidermal Growth Factor Receptor (EGFR) family of proteins. Payload is potent topoisomerase I inhibitor with high membrane permeability. With bystander effect it provides neighbor cell death. Drug-to antibody ratio is 7-8.

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

<Summary>
The molecular-targeted agent to inhibit CSF-1R, KIT and FLT3. This agent is expected to reduce tumor cell proliferation and expansion of metastases.

DS-3201
(JP/US)

(EZH1/2 inhibitor)
DS-8201
(JP/Asia)

(Gastric cancer/anti-HER2 ADC)
   
Generic Name Class Target indication Region/Stage
DS-3201 EZH1/2 inhibitor Non-Hodgkin's lymphoma JP P1
Acute Myeloid Leukemia (AML),
Acute Lymphoblastic Leukemia (ALL)
US P1
Generic Name Class Target indication Region/Stage Remarks
Trastuzumab deruxtecan / DS-8201 Anti-HER2 antibody drug conjugate Gastric cancer JP/Asia P2 Granted SAKIGAKE Designation for the treatment of HER2-positive advanced gastric or gastroesophageal junction cancer by the MHLW.

<Summary>
The drug (payload) conjugated through linker to the fully human monoclonal antibody to target HER2, one of the Epidermal Growth Factor Receptor (EGFR) family of proteins. Payload is potent topoisomerase I inhibitor with high membrane permeability. With bystander effect it provides neighbor cell death. Drug-to antibody ratio is 7-8.

PLX73086
(US)

(CSF-1R inhibitor)
DS-8201
(JP/US/EU)

(CRC/anti-HER2 ADC)
   
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
Trastuzumab deruxtecan / DS-8201 Anti-HER2 antibody drug conjugate Colorectal cancer JP/US/EU P2

<Summary>
The drug (payload) conjugated through linker to the fully human monoclonal antibody to target HER2, one of the Epidermal Growth Factor Receptor (EGFR) family of proteins. Payload is potent topoisomerase I inhibitor with high membrane permeability. With bystander effect it provides neighbor cell death. Drug-to antibody ratio is 7-8.

PLX51107
(US)

(BRD4 inhibitor)
DS-8201
(JP/US/EU)

(NSCLC/anti-HER2 ADC)
   
Generic Name Class Target indication Region/Stage
PLX51107 BRD4 inhibitor Acute Myeloid Leukemia (AML),
Myelodysplastic syndrome (MDS)
US P1
Generic Name Class Target indication Region/Stage
Trastuzumab deruxtecan / DS-8201 Anti-HER2 antibody drug conjugate Non-Small Cell Lung Cancer (NSCLC) JP/US/EU P2 prep

<Summary>
The drug (payload) conjugated through linker to the fully human monoclonal antibody to target HER2, one of the Epidermal Growth Factor Receptor (EGFR) family of proteins. Payload is potent topoisomerase I inhibitor with high membrane permeability. With bystander effect it provides neighbor cell death. Drug-to antibody ratio is 7-8.

U3-1402
(JP/US)

(Anti-HER3 ADC)
KTE-C19
(JP)

(Large B Cell Lymphoma/anti-CD19 CAR T cells)
   
Generic Name Class Target indication Region/Stage
U3-1402 Anti-HER3 antibody drug conjugate Breast cancer JP/US P1/2
Non-Small Cell Lung Cancer (NSCLC) US P1
Generic Name Class Target indication Region/Stage
Axicabtagene Ciloleucel/KTE-C19 Anti-CD19 CAR T cells Large B Cell Lymphoma JP P2 prep
DS-1001
(JP)

(IDH1m inhibitor)
     
Generic Name Class Target indication Region/Stage
DS-1001 IDH1 mutant inhibitor Glioma JP P1
DS-1205
(US)

(AXL inhibitor)
     
Generic Name Class Target indication Region/Stage Remarks
DS-1205 AXL inhibitor Non-Small Cell Lung Cancer (NSCLC) US P1 prep Combination with osimertinib
PLX2853
(US)

(BRD4 inhibitor)
     
Generic Name Class Target indication Region/Stage
PLX2853 BRD4 inhibitor Solid tumors US P1
DS-1062
(US/JP)

(Anti-TROP2 ADC)
     
Generic Name Class Target indication Region/Stage
DS-1062 Anti-TROP2 antibody drug conjugate Solid tumors (Non-Small Cell Lung Cancer) US/JP P1
Quizartinib
(US)

(AC220 / AML-2nd / FLT3 inhibitor)
     
Generic Name Class Target indication Region/Stage Remarks
Quizartinib FLT3 inhibitor Acute Myeloid Leukemia (AML) US P1 prep Combination with DS-3032

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

Pexidartinib
(Asia)

(PLX3397 / Solid tumors / CSF-1R / KIT /FLT3 inhibitor)
     
Generic Name Class Target indication Region/Stage
Pexidartinib/PLX3397 CSF-1R/KIT/FLT3 inhibitor Solid tumors Asia P1

<Summary>
The molecular-targeted agent to inhibit CSF-1R, KIT and FLT3. This agent is expected to reduce tumor cell proliferation and expansion of metastases.

DS-8201
(US/EU)

(Breast cancer, Urothelial (bladder) cancer /anti-HER2 ADC)
     
Generic Name Class Target indication Region/Stage Remarks
Trastuzumab deruxtecan / DS-8201 Anti-HER2 antibody drug conjugate Breast cancer, Urothelial (bladder) cancer US/EU P1 prep Combination with nivolumab

<Summary>
The drug (payload) conjugated through linker to the fully human monoclonal antibody to target HER2, one of the Epidermal Growth Factor Receptor (EGFR) family of proteins. Payload is potent topoisomerase I inhibitor with high membrane permeability. With bystander effect it provides neighbor cell death. Drug-to antibody ratio is 7-8.

Specialty Medicine DS-1040
(US/EU/JP)

(Acute ischemic stroke, Acute pulmonary embolism / TAFIa inhibitor)
  Edoxaban
(JP)

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

(DU-176b / AF / FXa inhibitor)
Generic Name Class Target indication Region/Stage
DS-1040 TAFIa inhibitor Acute ischemic stroke, Acute pulmonary embolism US/EU/JP P1
Generic Name Class Target indication Region/Stage Remarks
Edoxaban
Lixiana (JP)
LIXIANA (EU, Asia)
SAVAYSA (US)
Factor Xa inhibitor Very elderly patients with non-valvular atrial fibrillation (AF) JP P3 Additional dosage and formulation
for very elderly (80 years and older) AF patients

<Summary>
The once daily oral anti coagulant (Factor Xa 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 BR: received approval in Mar 2018
CN: submitted in Aug 2015

<Summary>
The once daily oral anti coagulant (Factor Xa 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)

(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, P3 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 BR: received approval in Mar 2018
CN: submitted in Aug 2015

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

DS-1501
(US)

(Osteoporosis / Anti-Siglec-15 antibody)
  Esaxerenone
(JP)

(CS-3150 / DM nephropathy / MR antagonist)
Mirogabalin
(JP/Asia)

(DS-5565 / DPNP / PHN / α2δ ligand)
Generic Name Class Target indication Region/Stage
DS-1501 Anti-Siglec-15 antibody Osteoporosis US P1
Generic Name Class Target indication Region/Stage
Esaxerenone/CS-3150 MR antagonist Diabetic nephropathy JP P3

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

Generic Name Class Target indication Region/Stage Remarks
Mirogabalin α2δ ligand Diabetic peripheral neuropathic pain JP/Asia Submitted JP: submitted in Feb 2018
Postherpetic neuralgia

<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.

DS-7080
(US)

(AMD / Angiogenesis inhibitor)
  Laninamivir
(JP)

(CS-8958 / Anti-influenza / nebulizer)
Esaxerenone
(JP)

(CS-3150 / Hypertension / MR antagonist)
Generic Name Class Target indication Region/Stage
DS-7080 Angiogenesis inhibitor Neovascular age-related macular degeneration (AMD), Diabetic Macular Edema (DME) US P1
Generic Name Class Target indication Region/Stage Remarks
Laninamivir
Inavir (JP)
Neuraminidase inhibitor Influenza JP P3 Additional dosage form, nebulizer formulation, obtained topline result of P3 study

<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
Esaxerenone/CS-3150 MR antagonist Hypertension JP Submitted Submitted in Feb 2018

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

DS-5141
(JP)

(DMD / ENA oligonucleotide)
  VN-0105
(JP)

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

(Nasal spray flu vaccine)
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
Announced TLR in Apr 2018
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-1211
(US)

(TNAP inhibitor)
  Intradermal Seasonal
Influenza Vaccine
(JP)

(VN-100 / prefilled i.d. vaccine for seasonal flu)
 
Generic Name Class Target indication Region/Stage Remarks
DS-1211 TNAP inhibitor Prevention of ectopic cacification diseases US P1 Research collaboration with Sanford Burnham Prebys Medical Discovery Institute
Generic Name Class Target indication Region/Stage Remarks
VN-100 Intradermal Seasonal Influenza Vaccine Prevention of seasonal Influenza JP P3 Submitted by Japan Vaccine in April 2015
* prefilled syringe
Status changed: P3 study conducted in Japan met its primary endpoint; however, could not establish commercial manufacturing method and Japan Vaccine dismissed NDA.

<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.

VN-0102/JVC-001
(JP)

(MMR vaccine)
     
Generic Name Class Target indication Region/Stage Remarks
VN-0102/JVC-001 Measles-Mumps-Rubella vaccine Prevention of Measles,
Mumps and Rubella
JP P1/2 Japan vaccine company is conducting the P1/2 study