Daiichi Sankyo
Drugmaker with rare disease work · based in Tokyo, Japan · founded 2005 · ticker 4568 · daiichisankyo.com
Daiichi Sankyo works on 7 rare diseases we track, including Acute Myeloid Leukemia, Adrenocortical Carcinoma and 5 more. It has 8 active clinical trials, and 3 are looking for volunteers now. It also has 2 FDA-approved rare disease drugs.
Daiichi Sankyo is a Japanese pharmaceutical company with roots dating back to 1899 (formed through the 2005 merger of Daiichi Pharmaceutical and Sankyo). It is best known for cancer drugs called antibody-drug conjugates.
Daiichi Sankyo pipeline
Each row lists the diseases Daiichi Sankyo is studying at that stage, from the ones closest to approval down to the earliest work.
Tenosynovial Giant Cell Tumor · HER2-Positive Primary Breast Cancer
Acute Myeloid Leukemia 3 trials recruiting · Hematological Malignancies recruiting · Duchenne Muscular Dystrophy
Adrenocortical Carcinoma recruiting
Daiichi Sankyo clinical trials
These are Daiichi Sankyo trials for the rare diseases we track, from ClinicalTrials.gov. Statuses there can lag behind company news, so confirm with the study team before you plan around one.
3 trials looking for volunteers now
Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission
Tests Quizartinib High Dose, Quizartinib Low Dose
For Acute Myeloid Leukemia and Leukemia
A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies
Tests DS3790a, Combination drug, Combination drug
For Hematological Malignancies and B-cell Non-Hodgkin Lymphoma
A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer
Tests DS9051b
For Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer
5 trials underway, not taking new volunteers
Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
Tests Decitabine, Quizartinib, Venetoclax
For Acute Myeloid Leukemia, Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome and Refractory Acute Myeloid Leukemia
Long-term, Extension Study of DS-5141b in Patients With Duchenne Muscular Dystrophy
Tests DS-5141b
For Duchenne Muscular Dystrophy
A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT
Tests Pexidartinib
For Tenosynovial Giant Cell Tumor
A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)
Tests DS-8201a, T-DM1
For HER2-Positive Primary Breast Cancer and Residual Invasive Breast Cancer
Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood
Tests Quizartinib, Fludarabine, Cytarabine, Intrathecal (IT) triple chemotherapy prophylaxis, Etoposide
Pick a condition. One email when a new trial opens, a trial changes or the FDA decides, from any company, not only Daiichi Sankyo. Unsubscribe anytime.
- Trial Alerts, when a new trial opens or a trial changes
- Disease Updates, FDA decisions and condition news, usually 1 or 2 emails a month
FDA-approved drugs from Daiichi Sankyo
From the openFDA database. Tap a drug for side effects, dosing and help paying.
Turalio pexidartinib hydrochloride
For Tenosynovial Giant Cell Tumor. Approved Aug 2, 2019. Taken by mouth.
Vanflyta quizartinib
For Acute Myeloid Leukemia. Approved Jul 20, 2023. Taken by mouth.
More about Daiichi Sankyo
Its FDA-approved rare disease medicines include Vanflyta (quizartinib), approved in July 2023 for newly diagnosed FLT3-ITD acute myeloid leukemia, and Turalio (pexidartinib), approved in August 2019 for adults with tenosynovial giant cell tumor that causes severe symptoms and cannot be helped by surgery. It is also running a first-in-human trial of DS9051b, a drug taken by mouth, in adrenocortical carcinoma (NCT07189403).
Where Daiichi Sankyo trials take place
The trials above run at 599 study sites in 32 countries. Tap a country to see its states, cities and hospitals.
Rare diseases Daiichi Sankyo works on
Each disease page lists every open trial, not only Daiichi Sankyo's, plus approved treatments.
Acute myeloid leukemia (AML) is a fast-growing cancer of the bone marrow in which immature white blood cells called blasts crowd out normal blood cells, causing fatigue, infections and bleeding...
How common: The National Cancer Institute's SEER program estimates 22,720 new US cases and 11,500 deaths in 2026, about 1.1% of new cancers, and 83,311 people were living with AML in 2023
Adrenocortical carcinoma is a rare, aggressive cancer of the adrenal cortex, the outer layer of the adrenal glands that sit on top of each kidney.
How common: About 1-2 per million people per year; approximately 600 new cases per year in the U.S
Cholangiocarcinoma is a rare and aggressive cancer that forms in the bile ducts, the thin tubes that carry digestive fluid (bile) from the liver to the small intestine.
How common: About 8,000 new cases per year in the U.S.; rising incidence worldwide
Duchenne muscular dystrophy is an X-linked genetic disorder causing progressive muscle weakness and degeneration, beginning in early childhood.
How common: 1 in 3,500 to 5,000 male births
Fibrodysplasia Ossificans Progressiva
Fibrodysplasia Ossificans Progressiva (FOP) is an extremely rare genetic disorder characterized by progressive heterotopic ossification, where soft tissues (muscles, tendons, ligaments) gradually...
How common: Extremely rare, about 1 in 1 million to 1 in 2 million people worldwide
Myelodysplastic syndromes are a group of blood cancers in which the bone marrow fails to produce enough healthy blood cells.
How common: 10,000 to 15,000 new cases annually in the U.S.; estimated 60,000 to 170,000 Americans living with MDS
Tenosynovial giant cell tumor (TGCT) is a rare tumor that grows in the lining of a joint, tendon sheath or bursa.
How common: A Dutch nationwide study found about 43 new cases per million people each year, 39 localized and 4 diffuse (Mastboom et al., 2017)
Where to get support
Patient groups can explain a diagnosis, point you to specialists and tell you about trials before they open. Daiichi Sankyo's own site is daiichisankyo.com, and our help paying for treatment page lists drugmaker programs and charity funds.
- National Cancer Institute - Adrenocortical CarcinomaAdrenocortical Carcinoma and Cholangiocarcinoma
- NCI SEER Cancer Stat Facts: Acute Myeloid LeukemiaAcute Myeloid Leukemia
- NCI PDQ: Acute Myeloid Leukemia Treatment, patient versionAcute Myeloid Leukemia
- ENSAT - European Network for Adrenal TumorsAdrenocortical Carcinoma
- Cholangiocarcinoma FoundationCholangiocarcinoma
- Muscular Dystrophy Association (MDA)Duchenne Muscular Dystrophy
- Parent Project Muscular Dystrophy (PPMD)Duchenne Muscular Dystrophy
- International FOP AssociationFibrodysplasia Ossificans Progressiva