Pipeline Chart

* As of October 2016
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 Stage
DS-3032 MDM2 inhibitor Solid cancer, lymphoma US/JP P1
Leukemia US P1
Generic Name Class Target indication 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 more potent to induce tumor cell proliferation than homodimers of HER2 or EGFR.

Generic Name Class Target indication Stage
Tivantinib MET inhibitor Hepatocellular cancer US/EU P3

<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.

  • A P3 clinical study for HCC with MET high patients was started in Jan-2013.
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 Stage
PLX7486 FMS/TRK inhibitor Solid cancer US P1
Generic Name Class Target indication Stage Remarks
Pexidartinib/PLX3397 CSF-1R/KIT/FLT3-ITD inhibitor Glioblastoma US P2  
Solid tumor Asia P1 Including TGCT
Melanoma US P2  
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 Stage Remarks
Denosumab 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. Launched in Japan in April 2012 as treatment for bone complications stemming from multiple myeloma and bone metastases from solid tumors, in June 2013 as treatment for osteoporosis, and in May 2014 as treatment for giant cell tumor of bone.

  • July, 2007 In-licensed from Amgen.
  • P3 : Breast cancer adjuvant, Rheumatoid arthritis.
  • September 2016 sNDA submission for rheumatoid arthritis (additional indication)
PLX8394
(US)

(BRAF inhibitor)
DS-1647
(JP)

(Glioblastoma / G47Δ virus)
Nimotuzumab
(JP)

(DE-766 / Gastric cancer / Anti-EGFR antibody)
 
Generic Name Class Target indication Stage
PLX8394 BRAF inhibitor Solid cancer, leukemia US P1
Generic Name Class Target indication Stage Remarks
DS-1647 G47Δ oncolytic virus Glioblastoma JP P2 SAKIGAKE Designation granted

<Summary>
A triple-mutated, replication-conditional herpes simplex virus type 1 (the third generation oncolytic herpes simplex virus type 1), designed to replicate only in cancer cells. This oncolytic virus therapy is expected better safety and efficacy profile compare to existing oncolytic virus. This product received SAKIGAKE Designation from MHLW on February 10th ,2016. Phase 2 Investigator Initiated Study for Glioblastoma is on-going in Japan.

Generic Name Class Target indication 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.

  • P3 in Japan for Gastric cancer started in April 2013.
DS-6051
(US/JP)

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

(PLX4032 / Melanoma Adjuvant / BRAF inhibitor)
 
Generic Name Class Target indication Stage
DS-6051 NTRK/ROS1 inhibitor Solid cancer US/JP P1
Generic Name Class Target indication Stage Remarks
Vemurafenib BRAF inhibitor Melanoma adjuvant US/EU P3 Additional indication. Licensee Roche is conducting the study. Submission in 2016 is planned.

<Summary>
The molecular-targeted agent to inhibit BRAF V600E mutation. Launched since 2011 as personalized treatment for patients with unrespectable or metastatic melanoma. NDA for combination therapy with MEK inhibitor cobimetinib was approved in US on November 11, 2015. A phase 1 study of a combination with anti PD-L1 monoclonal antibody atezolizumab and cobimetinib is being investigated by Genentech.

PLX9486
(US)

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

(AC220 / AML-2nd / FLT3-ITD inhibitor)
 
Generic Name Class Target indication Stage
PLX9486 KIT inhibitor Solid cancer US P1
Generic Name Class Target indication 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. Started phase 3 study in EU and Asia in addition to US
JP P1  

<Summary>
Kinase inhibitor against a receptor-type tyrosine kinase, FLT3.
Therapeutic effect for patients with acute myeloid leukemia harboring FLT-ITD3 mutation is expected.

DS-3201
(JP)

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

(AC220 / AML-1st / FLT3-ITD inhibitor)
 
Generic Name Class Target indication Stage
DS-3201 EZH1/2 inhibitor Non-Hodgkin's lymphoma JP P1
Generic Name Class Target indication 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. Started phase 3 study in EU and Asia in addition to US
JP P1  

<Summary>
Kinase inhibitor against a receptor-type tyrosine kinase, FLT3.
Therapeutic effect for patients with acute myeloid leukemia harboring FLT-ITD3 mutation is expected.

PLX73086
(US)

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

(PLX3397 / TGCT / CSF-1R/KIT/FLT3-ITD inhibitor)
 
Generic Name Class Target indication Stage
PLX73086/AC708 CSF-1R inhibitor Tenosynovial Giant Cell Tumor (TGCT) US P1
Generic Name Class Target indication 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 Stage
PLX51107 BRD4 inhibitor Hematologic malignancies US P1
DS-8895
(JP)

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

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

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

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

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

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

(Anti-HER3 ADC)
     
Generic Name Class Target indication Stage Remarks
U3-1402 Anti-HER3 antibody drug conjugate Solid cancer JP P1 Started phase 1 study
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 Stage
DS-1040 TAFIa inhibitor Acute ischemic stroke - P1
Generic Name Class Target indication Stage
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.

  • On January 2015, Ph2bs of HTN and DN started.
  • On November 2015, Ph.2b study in essential hypertension in Japan was completed.
  • In September 2016, phase 3 of HTN started.
Generic Name Class Target indication Stage Remarks
Edoxaban 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.Launched in Japan in July 2011 as the prevention of venous thromboembolism (VTE) in patients with total knee arthroplasty, total hip arthroplasty and hip fracture surgery.

  • Top line results of Hokusai-VTE (VTE) P3 study was presented at ESC 2013.
  • Top line results of ENGAGE AF-TIMI 48 (AF) P3 study was presented at AHA 2013.
  • AF/VTE indication: Following the launch in Japan in Sep 2014 (Dec 2014 for 60 mg tablet), edoxaban has already been marketed in more than 10 countries.
Generic Name Class Target indication Region Filing year/month
Edoxaban Factor Xa inhibitor Atrial fibrillation (AF) ASCA etc. BR (14/6*), TH(15/7), CN(15/8), CA(15/8), TR(15/10)
* means June 2014, ditto

<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.

  • Top line results of Hokusai-VTE (VTE) P3 study was presented at ESC 2013.
  • Top line results of ENGAGE AF-TIMI 48 (AF) P3 study was presented at AHA 2013.
  • AF/VTE indication: Following the launch in Japan in Sep 2014 (Dec 2014 for 60 mg tablet), edoxaban has already been marketed in more than 10 countries.
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 Stage
DS-2330 Hyperphosphatemia treatment Hyperphosphatemia in chronic kidney disease (CKD) - P1
Generic Name Class Target indication Stage
DS-8500 GPR119 agonist Diabetes JP/US P2

<Summary>
The agent agonistically acts on GPR119 which is expressed in small intestine and pancreas cells, stimulates insulin secretion, and lowers blood sugar concentration.

Generic Name Class Target indication Stage Remarks
Prasugrel Anti-platelet agent Ischemic stroke JP P3 Additional indication

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

  • Co-development with Eli Lilly in the US and EU, development by Daiichi Sankyo in Japan.
  • [JP] Approved in Mar 2014 for the ischemic heart disease undergoing PCI and launched in May 2014. P3 studies for ischemic stroke are on-going.
  • [US] P3 study in pediatric sickle cell disease patients was conducted. The patent exclusivity in US has been extended for 180 days based on the pediatric study completion.
Generic Name Class Target indication Region Filing year/month
Edoxaban Factor Xa inhibitor Venous thromboembolism (VTE) ASCA etc. BR (14/6), TH(15/7), CN(15/8), CA(15/8), TR(15/10)

<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.

  • Top line results of Hokusai-VTE (VTE) P3 study was presented at ESC 2013.
  • Top line results of ENGAGE AF-TIMI 48 (AF) P3 study was presented at AHA 2013.
  • AF/VTE indication: Following the launch in Japan in Sep 2014 (Dec 2014 for 60 mg tablet), edoxaban has already been marketed in more than 10 countries.
DS-9231/TS23
(Thrombosis / α2-PI inactivating antibody)
  Esaxerenone
(JP)

(CS-3150 / Hypertension / MR antagonist)
 
Generic Name Class Target indication 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 Stage Remarks
CS-3150 MR antagonist Hypertension JP P3 Started phase 3 study

<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.

  • On January 2015, Ph2bs of HTN and DN started.
  • On November 2015, Ph.2b study in essential hypertension in Japan was completed.
  • In September 2016, phase 3 of HTN started.
DS-9001
(Dyslipidemia / Anti-PCSK9 Anticalin-Albumod)
     
Generic Name Class Target indication Stage
DS-9001 Anti-PCSK9 Anticalin-Albumod Dyslipidemia - P1
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 Stage
DS-1971 Analgesic agent Chronic pain - P1
Generic Name Class Target indication Stage Remarks
Laninamivir Neuraminidase inhibitor Influenza US/EU P2 Out-licensing with Biota
JP P1 Nebulizer formulation
Generic Name Class Target indication 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.

  • Phase 2 studies for diabetic peripheral neuropathic pain were completed.
  • Phase 3 studies for diabetic peripheral neuropathic pain and postherpetic neuralgia are in execution in JP/Asia.
  • Phase 3 studies for fibromyalgia are in execution in US/EU.
Generic Name Class Target indication Region Remarks
Hydromorphone Opioid mu-receptor agonist Cancer pain JP NDA of oral formulation (extended-release and immediate-release formulations) was submitted in March 2016 by Daiichi Sankyo Propharma

<Summary>
Hydromorphone hydrochloride is an opiate, narcotic analgesic that has been available outside of Japan for over 80 years and it is the standard for pain management for cancer pain treatment according to WHO guidelines. Hydromorphone hydrochloride is one of the agents publicly offered for development by the Review Committee on Unapproved Drugs and Indications with High Medical Needs. Daiichi Sankyo decided to develop the drug in 2012.

  • NDA of oral formulations (extended-release and immediate-release formulations) were submitted in Mar 2016 by Daiichi Saknyo Propharma. Ph2/3 studies for injection formulation are ongoing.
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 Stage
DS-1501 Anti-Siglec-15 antibody Osteoporosis US P1
Generic Name Class Target indication 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.

  • Phase 2 studies for diabetic peripheral neuropathic pain were completed.
  • Phase 3 studies for diabetic peripheral neuropathic pain and postherpetic neuralgia are in execution in JP/Asia.
  • Phase 3 studies for fibromyalgia are in execution in US/EU.
Generic Name Class Target indication Region Remarks
CL-108 Opioid mu-receptor agonist combination Acute pain US NDA was submitted in March 2016 by Charleston Laboratories, Inc., licensor and co-development partner

<Summary>
CL-108 is novel hydrocodone combination products being developed by Charleston Lab and Daiichi Sankyo for the treatment of moderate to severe pain while preventing or reducing Opioid-Induced Nausea and Vomiting (OINV). The product expects to reduce the unwanted side effects of opioid-induced nausea and vomiting.

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 Stage
DS-7080 Angiogenesis inhibitor Neovascular age-related macular degeneration (AMD) US P1
Generic Name Class Target indication 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.

  • Phase 2 studies for diabetic peripheral neuropathic pain were completed.
  • Phase 3 studies for diabetic peripheral neuropathic pain and postherpetic neuralgia are in execution in JP/Asia.
  • Phase 3 studies for fibromyalgia are in execution in US/EU.
Generic Name Class Target indication Region Filing year/month
VN-100 Intradermal influenza HA 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, Japan Vaccine and Kitasato Daiichi Sankyo Vaccine Co., Ltd.]. The intradermal injection device for this vaccine is developed by Terumo. 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 Stage
DS-2969 GyrB inhibitor Clostridium difficile infection (CDI) - P1
Generic Name Class Target indication Stage Remarks
Hydromorphone Opioid mu-receptor agonist Cancer pain JP P3 Injection formulation

<Summary>
The opiate, narcotic analgesic that has been available outside of Japan for over 80 years and recommended in WHO guideline as a standard analgesia for cancer pain. It is designated as unapproved drug by "Study Group on Unapproved and Off-label Drugs of High Medical Need."

  • NDA of oral formulations (extended-release and immediate-release formulations) were submitted in Mar 2016 by Daiichi Saknyo Propharma. Ph2/3 studies for injection formulation are ongoing.
Generic Name Class Target indication 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 Stage
DS-5141 ENA oligonucleotide Duchenne muscular dystrophy JP P1/2
Generic Name Class Target indication Stage Remarks
CHS-0214 TNFα inhibitor Rheumatoid arthritis JP P3 Etanercept biosimilar

<Summary>
Biosimilar product for etanercept

  • Phase 3 study for patients with rheumatoid arthritis in Japan was completed. In preparation for submission.
Generic Name Class Target indication Stage Remarks
Denosumab Anti-RANKL antibody Rheumatoid arthritis JP Additional Indication, submitted in Sep 2016

<Summary>
Denosumab is fully human monoclonal antibody to target RANK Ligand, an essential mediator of osteoclast formation, in-licensed from Amgen Inc. in 2007. Daiichi Sankyo began sales in Japan of a 60 mg preparation of denosumab as a therapeutic agent for osteoporosis under the product name PRALIA® subcutaneous injection 60mg syringe in June 2013. In addition, from April 2012 Daiichi Sankyo began sales of a 120 mg preparation of denosumab as a therapeutic agent to treat bone complications stemming from multiple myeloma and bone metastases from solid tumors under the product name RANMARK® subcutaneous injection 120 mg, and from May 2014, as a therapeutic agent to treat giant cell tumor of bone under the product name RANMARK® subcutaneous injection 120 mg. Daiichi Sankyo is also participating in global phase 3 clinical trials of denosumab as adjuvant treatment for women with breast cancer.

  • July, 2007 In-licensed from Amgen.
  • Phase 3 : Breast cancer adjuvant.
  • September 2016 sNDA submission for rheumatoid arthritis (additional indication)
VN-0102/JVC-001
(JP)

(MMR vaccine)
  VN-0105
(JP)

(DPT-IPV / Hib vaccine)
 
Generic Name Class Target indication 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 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 previously licensed and launched in Japan, as 1st in the class of pentavalent vaccine (DPT-IPV/Hib).

  • Ph3 study in Japan started in Oct 2014.