Late-stage Products

We deliver innovative products that enhance the lives of millions of people around the world.

Prasugrel

Daiichi Sankyo discovered prasugrel, an oral antiplatelet agent that prevents blood clots, with our Japanese research partner, Ube Industries, and developed it globally in collaboration with Eli Lilly and Company. In 2009, we launched it as Effient® in the United States and as Efient® in Europe to prevent atherothrombotic events in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). To date, prasugrel has been approved in more than 70 countries around the world.

In Japan, prasugrel was developed in collaboration with Ube Industries. We launched Efient® for the treatment of patients with ischemic heart disease undergoing PCI in May 2014. Phase 3 studies on patients with ischemic cerebrovascular disease were completed in 2016, and Daiichi Sankyo is evaluating the data with regard to the next step.

Edoxaban

Developed solely by Daiichi Sankyo, edoxaban is an once-daily, oral anticoagulant that specifically, reversibly and directly inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting. In 2011, we launched edoxaban as Lixiana® in Japan for the prevention of venous thromboembolism (VTE) in patients undergoing total knee replacement surgery, total hip replacement surgery, and hip fracture surgery.

Based on the two global phase 3 studies, ENGAGE AF-TIMI 48 for the prevention of stroke or systematic embolic events in patients with atrial fibrillation (irregular heart rate) and Hokusai-VTE for the treatment and prevention of recurrences of VTE in patients with an acute symptomatic deep vein thrombosis (DVT) and/or pulmonary embolism (PE), edoxaban is now approved and launched for those indications in more than 20 countries worldwide.

Daiichi Sankyo is committed to expanding scientific knowledge about edoxaban, as demonstrated through our research programs evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings in atrial fibrillation (AF) and venous thromboembolism (VTE). The extensive edoxaban research program includes multiple RCTs (randomized, controlled trials), registries and non-interventional studies, with the goal of generating new clinical and real-world-data regarding its use in AF and VTE populations. Daiichi Sankyo expects that more than 100,000 patients will participate in the Edoxaban Clinical Research Program, including completed, ongoing and future research.

Edoxaban Clinical Research Program

Denosumab

Denosumab is the world’s first fully human monoclonal antibody that specifically targets human RANK ligand, a protein that plays a key role in bone breakdown. Daiichi Sankyo has been working on denosumab since 2007, when we received the rights from Amgen Inc. to manufacture the antibody in Japan. In April 2012, Denosumab went on sale in Japan as RANMARK® for the treatment of bone complications stemming from multiple myeloma and bone metastases from solid tumors, and in May 2014 for the treatment of giant cell tumor of bone.

Additionally, denosumab received approval in Japan for the treatment of osteoporosis in March 2013 and went on sale in June 2013 as PRALIA®. Daiichi Sankyo also applied for Japan-sNDA approval for treatment of rheumatoid arthritis patients in September 2016 and currently it is under the review. In addition, Daiichi Sankyo is currently participating in a global phase 3 study of adjuvant treatment for women with early-stage breast cancer (D-CARE).

Mirogabalin

Mirogabalin, originally developed by Daiichi Sankyo, is preferentially selective in regard to how it binds to α2δ-1 subunit, a protein that may help to regulate how the brain processes pain signals. It has a unique binding profile and long duration of action, and is currently being studied for the treatment of pain associated with fibromyalgia and peripheral neuropathic pain (diabetic peripheral neuropathic pain and postherpetic neuralgia). A global phase 3 clinical trial for pain associated with fibromyalgia is ongoing mainly in the US and Europe, while a phase 3 clinical trial for peripheral neuropathic pain (diabetic peripheral neuropathic pain and postherpetic neuralgia) is currently underway in Japan and other Asian countries.

CL-108

CL-108 is a fixed-dose, immediate-release bi-layered tablet with a rapid release layer containing 12.5 mg of promethazine and a second layer containing 7.5 mg of hydrocodone and 325 mg of acetaminophen. If approved, CL-108 would represent the first opioid-containing formulation indicated to relieve moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting (OINV). Opioid-related adverse events, such as nausea and vomiting, may significantly compromise the management of pain. Reports in the literature suggest approximately 40 percent of patients experience OINV The incidence may be higher in clinical practice. In August 2014, Charleston Laboratories Inc. and Daiichi Sankyo signed an exclusive U.S. license agreement to co-develop and co-commercialize CL-108.

Quizartinib

Quizartinib is an investigational oral potent and selective FLT3 inhibitor currently in phase 3 development for newly-diagnosed and relapsed /refractory - acute myeloid leukemia (AML) with FLT3-ITD mutations. Quizartinib has been granted Orphan Drug Designation by the FDA and EMA for the treatment of AML. Quizartinib also has been granted Fast Track Designation by the FDA for the treatment of relapsed/refractory AML.

Two phase 3 studies of quizartinib are currently underway. QuANTUM-First: This study is evaluating quizartinib in combination with induction and consolidation chemotherapy as well as a maintenance therapy for newly-diagnosed AML patients with FLT3-ITDmutations. QuANTUM-R: This study is evaluating quizartinib versus salvage chemotherapy in relapsed/refractory AML patients with FLT3-ITD mutations.

Pexidartinib

Pexidartinib is a kinase inhibitor being jointly developed by Daiichi Sankyo and Plexxikon, a member of the Daiichi Sankyo Group, which selectively inhibits the receptors tyrosine kinase of CSF-1R/Kit/Flt3-ITD. It is currently in Phase 3 development for tenosynovial giant cell tumor (TGCT), a rare and usually non-metastatic tumor affecting the synovium-lined joints, bursae and tendon sheaths. TGCT is a group of neoplasms including pigmented villonodular synovitis (PVNS) and giant cell tumors of the tendon sheath (GCT-TS).

Pexidartinib has been granted Orphan Drug Designation and Breakthrough Therapy Designation by the FDA for the treatment of TGCT. It also has received Orphan Drug Designation from EMA for the treatment of TGCT.

Global Vision and Mission

Pharmaceutical innovation and therapeutic advances have had a dramatic impact on the ...