Daiichi Sankyo

Daiichi Sankyo works on 10 rare diseases tracked on Trial Friend, including Adrenocortical Carcinoma, Cholangiocarcinoma, Duchenne Muscular Dystrophy and 7 more, with 11 recruiting clinical trials and 3 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). The company is a global leader in antibody-drug conjugates for oncology, with programs touching rare cancers such as adrenocortical carcinoma and hereditary diffuse gastric cancer.

Type
Diversified Pharma
Ticker
4568
Headquarters
Tokyo, Japan
Founded
2005
11
Active Rare Disease Trials
3
Approved Rare Disease Drugs
10
Rare Diseases in Portfolio
21
Years Active

Focus areas at Daiichi Sankyo

Within its broader pharmaceutical portfolio, Daiichi Sankyo has active clinical trial programs and drug development efforts across 10 rare diseases, including Adrenocortical Carcinoma, Cholangiocarcinoma, Duchenne Muscular Dystrophy, Fibrodysplasia Ossificans Progressiva, Gastrointestinal Stromal Tumor, and 5 additional rare conditions. These programs may span orphan drug designation, novel therapeutic mechanisms, and precision medicine approaches targeting the underlying causes of each disease.

The clinical trials section below shows all active and recruiting studies sponsored by Daiichi Sankyo, sourced live from ClinicalTrials.gov. Each trial includes its current recruitment status, study phase (Phase 1 through Phase 4), conditions under investigation, and the number of active trial sites. The FDA-approved drugs section lists treatments that have received U.S. Food and Drug Administration approval, with brand names, generic names, approval dates, and matched rare disease indications from the openFDA database.

Daiichi Sankyo is headquartered in Tokyo, Japan, founded in 2005, publicly traded under the ticker symbol 4568. The company maintains a dedicated rare disease division alongside its broader therapeutic portfolio, working to bring innovative treatments to patients with conditions that have historically had limited or no treatment options.

Daiichi Sankyo Drug Pipeline

Daiichi Sankyo has 11 active clinical trials across 3 development stages, with 11 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.

Note: This pipeline includes all of Daiichi Sankyo's active interventional trials, not only those targeting rare diseases. We show the full pipeline because a company's broader research activity, therapeutic expertise, and development infrastructure directly shape its ability to advance rare disease programs. A strong overall pipeline often signals deeper clinical operations, faster enrollment capabilities, and greater commitment to bringing new treatments to patients.

Understand Daiichi Sankyo's pipeline
Type your own question with a little about your situation, and get an answer with sources.
Tap to start:
Or start with one of these
1
Early Phase / Phase 11 trial
7
Phase 27 trials
Endometrial Cancer+4 more
Recruiting
Castration-Resistant Prostatic Cancer+1 more
Recruiting
Acute Myeloid Leukemia+1 more
Recruiting
Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer)
Recruiting
Hematological Malignancies+1 more
Recruiting
3
Phase 33 trials
Ovarian Cancer+3 more
Recruiting
Endometrial Cancer
Recruiting
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Recruiting

Daiichi Sankyo Clinical Trials (11)

Active and recruiting clinical trials sponsored by Daiichi Sankyo, sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.

Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.

Ask about Daiichi Sankyo's trials
Type your own question with a little about your situation, and get an answer with sources.
Tap to start:
Or start with one of these
RECRUITINGPHASE3Recently updatedNCT07776691

A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04)

Intervention: R-DXd, Bevacizumab

Ovarian CancerOvarian NeoplasmsPeritoneal CancerFallopian Tube Cancer

Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include: Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread. Observation, which is watching to see if cancer grows or worsens. The study medicine, raludotatug deruxtecan- R-DXd, is a targeted therapy. The goal of this study is to learn if people who receive R-DXd maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.

Ages 18 Years+3 locations
View full study
RECRUITINGPHASE2Recently updatedNCT05489211

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Intervention: Datopotamab deruxtecan (Dato-DXd), Capecitabine, 5-Fluorouracil, Volrustomig, Carboplatin, Bevacizumab, Rilvegostomig, Prednisone/ prednisolone, Cisplatin

Endometrial CancerGastric CancerMetastatic Castration-resistant Prostate CancerOvarian CancerColorectal Cancer

TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours.

Ages 18 Years - 130 Years96 locations
View full study
RECRUITINGPHASE1, PHASE2Recently updatedNCT06863272

A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02)

Intervention: Docetaxel, Ifinatamab Deruxtecan, Opevesostat, Abiraterone, Enzalutamide, Rescue Medication

Castration-Resistant Prostatic CancerMetastasis

The purpose of this substudy is to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd), given alone or with other treatments in participants with metastatic castration-resistant prostate cancer (mCRPC). The goals of this study are to learn about: * The safety of the study treatment and if people tolerate it. * A safe dose level of I-DXd that can be used with other treatments. * Participant levels of prostate specific antigen (PSA) during treatment.

Ages 18 Years+82 locations
View full study
RECRUITINGPHASE2Recently updatedNCT06824168

Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission

Intervention: Quizartinib High Dose, Quizartinib Low Dose

Acute Myeloid LeukemiaLeukemia

This clinical two-arm trial is designed to evaluate two doses of quizartinib as maintenance therapy after induction/consolidation in participants with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) (+) acute myeloid leukemia (AML) in first complete remission (CR) who have not received allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Ages 18 Years+64 locations
View full study
ACTIVE NOT RECRUITINGPHASE2Recently updatedNCT06271837

A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Selected HER2-expressing Tumors

Intervention: Trastuzumab deruxtecan, Bevacizumab

Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer)

This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of trastuzumab deruxtecan as monotherapy or in combination with anti-cancer agents for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2-expressing solid tumors which are not eligible for curative therapy.

Ages 18 Years - 130 Years29 locations
View full study
RECRUITINGPHASE3Recently updatedNCT06989112

DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer

Intervention: Trastuzumab deruxtecan, Rilvegostomig, Pembrolizumab, Carboplatin, Paclitaxel, Docetaxel

Endometrial Cancer

DESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.

Ages 18 Years+255 locations
View full study
RECRUITINGPHASE1, PHASE2Recently updatedNCT07220616

A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies

Intervention: DS3790a, Combination drug, Combination drug

Hematological MalignanciesB-cell Non-Hodgkin Lymphoma

This clinical trial is designed to assess the safety, preliminary efficacy, and pharmacokinetics (PK) of DS3790a monotherapy and combination regimens in participants with hematological malignancies.

Ages 18 Years+8 locations
View full study

Daiichi Sankyo FDA-Approved Drugs (3)

Medications developed or marketed by Daiichi Sankyo that have received U.S. Food and Drug Administration approval. Drug data is sourced from the openFDA database and includes brand names, generic names, approval dates, and matched rare disease indications. Where a drug treats a condition covered by Trial Friend, the disease name links directly to that disease page.

Drug NameBrand NameRare DiseasesApproval Date
FAM-TRASTUZUMAB DERUXTECAN-NXKIEnhertu
intravenous
Dec 20, 2019
EDOXABAN TOSYLATESAVAYSA
oral
Jan 8, 2015
QUIZARTINIBVANFLYTA
oral
Jul 20, 2023

Daiichi Sankyo Trial Locations

Daiichi Sankyo clinical trials are running at 697 sites in 32 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.

United States
129▼
China
120▼
France
52▼
Japan
45▼
Brazil
37▼
South Korea
34▼
Italy
31▼
Germany
29▼
Spain
26▼
Canada
25▼
Taiwan
21▼
Poland
19▼

Rare Disease Focus Areas (10)

Diseases targeted by Daiichi Sankyo's clinical trial and drug development programs

Adrenocortical CarcinomaRare Cancers

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. These glands produce essential hormones including cor...

Prevalence: About 1-2 per million people per year; approximately 600 new cases per year in the U.S.
CholangiocarcinomaRare Cancers

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. It can occur inside the liver (...

Prevalence: About 8,000 new cases per year in the U.S.; rising incidence worldwide
Duchenne Muscular DystrophyNeurological & Neuromuscular

Duchenne muscular dystrophy is an X-linked genetic disorder causing progressive muscle weakness and degeneration, beginning in early childhood. The defective dystrophin protein normally protects muscl...

Prevalence: 1 in 3,500 to 5,000 male births
Fibrodysplasia Ossificans ProgressivaConnective Tissue & Musculoskeletal

Fibrodysplasia Ossificans Progressiva (FOP) is an extremely rare genetic disorder characterized by progressive heterotopic ossification, where soft tissues (muscles, tendons, ligaments) gradually tran...

Prevalence: Extremely rare, approximately 1 per 2 million people globally; extremely small patient population
Gastrointestinal Stromal TumorRare Cancers

Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors of the gastrointestinal tract, arising from the interstitial cells of Cajal or their precursors. Most GISTs are driven by...

Prevalence: About 4,000-6,000 new cases per year in the U.S.; true incidence may be higher as small GISTs are often incidentally discovered
Hereditary Diffuse Gastric CancerGastrointestinal

Hereditary diffuse gastric cancer is an autosomal dominant cancer predisposition syndrome caused by germline CDH1 mutations. Nearly all carriers develop diffuse gastric cancer by age 80 if not treated...

Prevalence: Estimated at 1 in 1,000 gastric cancer cases; ~1 in 100,000 in general population

Patient Resources

Organizations and resources related to Daiichi Sankyo's rare disease focus areas

Frequently Asked Questions About Daiichi Sankyo

Common questions about Daiichi Sankyo's rare disease programs, clinical trials, and treatments.