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Otsuka Holdings Co., Ltd. clinical trials

The registry lists 780 studies whose lead sponsor is Otsuka Holdings Co., Ltd. or one of 29 companies grouped under it. 58 are recruiting or about to start. Per ClinicalTrials.gov, last updated Oct 23, 2026.

Keep track of what changes. Save the Otsuka Holdings Co., Ltd. studies recruiting or about to start, and get an email each week — studies that open, close, add sites or post results.

Watch these studies

Status

Completed: 598
Terminated: 74
Recruiting: 46
Active, not recruiting: 25
Status unknown: 13
Withdrawn: 10

Phase

Phase 3: 284
Phase 1: 207
Phase 2: 199
Phase 4: 53

Where

United States: 398
Japan: 210
Spain: 76
Canada: 76
Korea, Republic of: 72
Germany: 72

Focus areas

Conditions Otsuka Holdings Co., Ltd. leads ten or more studies in, by study count. A broader condition is left out when almost all its studies are already in a narrower one listed here.

Show all 28 areas

Stress Disorders, Post-Traumatic11 Carcinoma, Non-Small-Cell Lung10 Colitis, Ulcerative10 Tuberculosis10

Studies

Recruiting first, then most recently updated. Showing 50 of 780. Browse all 780 →

A Long-term Trial of EB-1020 in Adult Patients With ADHDRecruitingNCT06926829Phase 3
Sponsor listed in the registry: Otsuka Pharmaceutical Co., Ltd.
A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)RecruitingNCT04782258Phase 3
Sponsor listed in the registry: Otsuka Pharmaceutical Development & Commercialization, Inc.
Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD PatientsRecruitingNCT06931080Phase 2/3
Sponsor listed in the registry: Otsuka Pharmaceutical Co., Ltd.
A Study of JNT-517 in Participants With Phenylketonuria (PKU)RecruitingNCT06971731Phase 3
Sponsor listed in the registry: Otsuka Pharmaceutical Development & Commercialization, Inc.
REXULTI General Use Results Survey in Patients With Hyperactivity, or Aggressive Behavior Associated With Alzheimer's DementiaRecruitingNCT06875986
Sponsor listed in the registry: Otsuka Pharmaceutical Co., Ltd.
LUPKYNIS Drug-use Results SurveyRecruitingNCT07053891
Sponsor listed in the registry: Otsuka Pharmaceutical Co., Ltd.
A Study in Adult Males With X-linked Congenital Nephrogenic Diabetes Insipidus to Test the Effects of NDI-5001 Given for Multiple Days and to Test How NDI-5001 is Tolerated and Taken up in the BodyRecruitingNCT07525960Phase 1
Sponsor listed in the registry: Otsuka Pharmaceutical Development & Commercialization, Inc.
A Trial of the Efficacy and Safety of a Fixed Dose of SEP-363856 in Adults With Generalized Anxiety DisorderRecruitingNCT07767903Phase 3
Sponsor listed in the registry: Otsuka Pharmaceutical Development & Commercialization, Inc.
A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety DisorderRecruitingNCT07786454Phase 3
Sponsor listed in the registry: Otsuka Pharmaceutical Development & Commercialization, Inc.
Nutritional Status in Patients With Chronic Kidney Disease Receiving 7.2% Amino Acids During HemodialysisRecruitingNCT07881627
Sponsor listed in the registry: PT Otsuka Indonesia
Global Paradise System US Post Approval StudyRecruitingNCT06297291
Sponsor listed in the registry: ReCor Medical, Inc. · ReCor Medical, Inc. — acquired company within the Otsuka Holdings Co., Ltd. group
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male AdultsNot yet recruitingNCT07455084Phase 1
Sponsor listed in the registry: Otsuka Pharmaceutical Development & Commercialization, Inc.
Trial of Sibeprenlimab in Children and Adolescents With Immunoglobulin A Nephropathy (IgAN)Not yet recruitingNCT07770815Phase 3
Sponsor listed in the registry: Otsuka Pharmaceutical Development & Commercialization, Inc.
A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor ResectionRecruitingNCT07128199Phase 3
Sponsor listed in the registry: Taiho Oncology, Inc.
A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the BodyRecruitingNCT07649265Phase 1
Sponsor listed in the registry: Otsuka Pharmaceutical Development & Commercialization, Inc.
A Study of ARC-02 in B-cell NHLRecruitingNCT07691606Phase 1
Sponsor listed in the registry: Taiho Oncology, Inc.
Early Access Program for Ulefnersen in Children, Adolescents and Adults With FUS-associated Amyotrophic Lateral Sclerosis (FUS-ALS)AvailableNCT07862959
Sponsor listed in the registry: Otsuka Pharmaceutical Development & Commercialization, Inc.
A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.RecruitingNCT05967689Phase 2
Sponsor listed in the registry: Taiho Oncology, Inc.
A Study to Evaluate the Effectiveness and Safety of Sibeprenlimab in Participants With Primary Membranous Nephropathy, Immune-mediated Focal Segmental Glomerulosclerosis, and Minimal Change DiseaseNot yet recruitingNCT07861113Phase 2
Sponsor listed in the registry: Otsuka Pharmaceutical Development & Commercialization, Inc.
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)RecruitingNCT04256317Phase 2/3
Sponsor listed in the registry: Taiho Oncology, Inc.
An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSDRecruitingNCT07836647Phase 3
Sponsor listed in the registry: Transcend Therapeutics · Unclear whether first submitted before or after Transcend Therapeutics became part of Otsuka Holdings Co., Ltd.
A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety DisorderRecruitingNCT07759128Phase 3
Sponsor listed in the registry: Otsuka Pharmaceutical Development & Commercialization, Inc.
An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)RecruitingNCT07456696Phase 3
Sponsor listed in the registry: Transcend Therapeutics · Unclear whether first submitted before or after Transcend Therapeutics became part of Otsuka Holdings Co., Ltd.
Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute SchizophreniaRecruitingNCT05325645Phase 3
Sponsor listed in the registry: Otsuka Pharmaceutical Co., Ltd.
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional DysregulationRecruitingNCT07759154Phase 3
Sponsor listed in the registry: Otsuka Pharmaceutical Development & Commercialization, Inc.
An Evaluation of the Long-Term Safety and Efficacy of TSND-201 for the Treatment of PTSDEnrolling by invitationNCT07670702Phase 3
Sponsor listed in the registry: Transcend Therapeutics · Unclear whether first submitted before or after Transcend Therapeutics became part of Otsuka Holdings Co., Ltd.
Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or RearrangementRecruitingNCT05727176Phase 2
Sponsor listed in the registry: Taiho Oncology, Inc.
A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes MellitusRecruitingNCT06575426Phase 1/2
Sponsor listed in the registry: Otsuka Pharmaceutical Factory, Inc.
Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene AbnormalitiesRecruitingNCT04683250Phase 1/2
Sponsor listed in the registry: Taiho Pharmaceutical Co., Ltd.
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered TogetherRecruitingNCT07446400Phase 1
Sponsor listed in the registry: Otsuka Pharmaceutical Development & Commercialization, Inc.
A Trial to Examine if Repinatrabit is Processed Differently in Adults With Reduced Liver or Kidney Function Compared to Adults With Normal Liver and Kidney FunctionRecruitingNCT07713758Phase 1
Sponsor listed in the registry: Otsuka Pharmaceutical Development & Commercialization, Inc.
A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic SyndromeRecruitingNCT04608110Phase 1
Sponsor listed in the registry: Taiho Pharmaceutical Co., Ltd.
AB122 Platform StudyRecruitingNCT04999761Phase 1
Sponsor listed in the registry: Taiho Pharmaceutical Co., Ltd.
A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)Enrolling by invitationNCT04093570Phase 2
Sponsor listed in the registry: Taiho Oncology, Inc.
Futibatinib (TAS-120) in Patients With Advanced Biliary Tract CancerRecruitingNCT07710885Phase 3
Sponsor listed in the registry: Taiho Pharmaceutical Co., Ltd.
The RADIANCE CED StudyRecruitingNCT07231757
Sponsor listed in the registry: ReCor Medical, Inc. · ReCor Medical, Inc. — acquired company within the Otsuka Holdings Co., Ltd. group
Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term UseRecruitingNCT05342493
Sponsor listed in the registry: Otsuka Pharmaceutical Co., Ltd.
An EAP Treatment Protocol of ZipalertinibAvailableNCT07601399
Sponsor listed in the registry: Taiho Oncology, Inc.
The "Global Paradise System" RegistryRecruitingNCT05027685
Sponsor listed in the registry: ReCor Medical, Inc. · ReCor Medical, Inc. — acquired company within the Otsuka Holdings Co., Ltd. group
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic ImpairmentRecruitingNCT04953910Phase 1
Sponsor listed in the registry: Taiho Oncology, Inc.
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal ImpairmentRecruitingNCT04953897Phase 1
Sponsor listed in the registry: Taiho Oncology, Inc.
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary TuberculosisRecruitingNCT07209761Phase 3
Sponsor listed in the registry: Otsuka Pharmaceutical Development & Commercialization, Inc.
Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)Enrolling by invitationNCT05248659Phase 2/3
Sponsor listed in the registry: Otsuka Pharmaceutical Development & Commercialization, Inc.
A Long-Term Study of JNT-517 in Participants With PhenylketonuriaRecruitingNCT06628128Phase 3
Sponsor listed in the registry: Otsuka Pharmaceutical Development & Commercialization, Inc.
A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/LymphomaRecruitingNCT07075328Phase 1/2
Sponsor listed in the registry: Otsuka Medical Devices Co., Ltd. Japan
An Efficacy Study of a Dietary Supplement Drink Mix for Urinary Health ImprovementRecruitingNCT07453693Not applicable
Sponsor listed in the registry: Bonafide Health · First submitted after Bonafide Health became part of Otsuka Holdings Co., Ltd.
A Long-term Administration Trial of SEP-363856 in Patients With SchizophreniaRecruitingNCT07225712Phase 3
Sponsor listed in the registry: Otsuka Pharmaceutical Co., Ltd.
A Long-term Trial of EB-1020 in Pediatric Patients With ADHDRecruitingNCT07087327Phase 3
Sponsor listed in the registry: Otsuka Pharmaceutical Co., Ltd.
A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHDRecruitingNCT07086313Phase 2/3
Sponsor listed in the registry: Otsuka Pharmaceutical Co., Ltd.
JDS-HF3.0 Supplementation on Menopause Related Quality of Life Outcomes in Postmenopausal WomenRecruitingNCT07238478Not applicable
Sponsor listed in the registry: Bonafide Health · First submitted after Bonafide Health became part of Otsuka Holdings Co., Ltd.