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Otsuka Pharmaceutical clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — current trials in our Japan register with Otsuka Pharmaceutical as lead sponsor. Synced 28 Sep 2026
14Current trials
9Recruiting now
9Drugs in these trials
1Trial register
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist
Compiled from ClinicalTrials.gov and CTIS registry records · Last verified · Editorial standards
At a glance

Otsuka Pharmaceutical is the lead sponsor of 14 current clinical trials in our Japan register. 9 are recruiting patients now. The most common phase is Phase 3. The drugs named most often in its trials are EB-1020 (Centanafadine), Difamilast and Brexpiprazole. The most-studied condition is Atopic Dermatitis (AD).

ClinicalTrials.gov trials by status

  • Recruiting964%
  • Not yet open214%
  • Active, closed321%

Trials by phase

  • Phase 3643%
  • Observational536%
  • Phase 2/3214%
  • Phase 117%
01

Clinical trials sponsored by Otsuka Pharmaceutical

14 on ClinicalTrials.gov
StudyPhaseStatusStartRegisters
A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD
NCT07086313 · ClinicalTrials.gov ↗ · Attention-Deficit Hyperactivity Disorder(ADHD)
Phase 2/3 Recruiting 2025-09 Japan
Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia
NCT05325645 · ClinicalTrials.gov ↗ · Acute Schizophrenia
Phase 3 Recruiting 2022-07 Japan
A Long-term Trial of EB-1020 in Adult Patients With ADHD
NCT06926829 · ClinicalTrials.gov ↗ · Attention Deficit Hyperactivity Disorder (ADHD)
Phase 3 Recruiting 2025-06 Japan
A Long-term Trial of EB-1020 in Pediatric Patients With ADHD
NCT07087327 · ClinicalTrials.gov ↗ · Attention-Deficit Hyperactivity Disorder(ADHD)
Phase 3 Recruiting 2025-09 Japan
A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia
NCT07225712 · ClinicalTrials.gov ↗ · Schizophrenia
Drug: Ulotaront
Phase 3 Recruiting 2025-12 Japan
LUPKYNIS Drug-use Results Survey
NCT07053891 · ClinicalTrials.gov ↗ · Lupus Nephritis
Observational Recruiting 2025-09 Japan
Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients
NCT06931080 · ClinicalTrials.gov ↗ · Attention Deficit Hyperactivity Disorder (ADHD)
Phase 2/3 Recruiting 2025-04 Japan
Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term Use
NCT05342493 · ClinicalTrials.gov ↗ · Migraine Disorders
Observational Recruiting 2022-04 Japan
REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically/Verbally Aggressive Behavior Due to Rapid Changes in Mood, Irritability, and/or Outbursts Associated With Dementia Due to Alzheimer's Disease)
NCT06875986 · ClinicalTrials.gov ↗ · Alzheimer Disease
Observational Recruiting 2025-04 Japan
A Phase 3 Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis
NCT07173478 · ClinicalTrials.gov ↗ · Atopic Dermatitis (AD)
Phase 3 Not yet open 2025-10 Japan
A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis
NCT07184645 · ClinicalTrials.gov ↗ · Atopic Dermatitis (AD)
Phase 3 Not yet open 2025-09 Japan
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
NCT04790175 · ClinicalTrials.gov ↗ · Antidiuretic Hormone, Inappropriate Secretion
Drug: Tolvaptan
Observational Active, closed 2021-03 Japan
Samtasu Post-marketing General Drug Use-results Survey in Patients With Volume Overload in Heart Failure.
NCT05712746 · ClinicalTrials.gov ↗ · Heart Failure
Observational Active, closed 2023-03 Japan
Phase 1 Trial of ASTX727 in Subjects With Lower-risk Myelodysplastic Syndromes
NCT03906695 · ClinicalTrials.gov ↗ · Lower-risk Myelodysplastic
Phase 1 Active, closed 2019-03 Japan

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Titles and statuses are copied from the registry as published.

02

Drugs in Otsuka Pharmaceutical trials

9 compounds

Drugs and biologicals named as interventions in these trials, with the number of this sponsor's trials that name each one. Placebos and generic comparators are excluded.

03

Conditions in Otsuka Pharmaceutical trials

11 conditions
Atopic Dermatitis (AD)2Attention-Deficit Hyperactivity Disorder(ADHD)2Attention Deficit Hyperactivity Disorder (ADHD)2Antidiuretic Hormone, Inappropriate Secretion1Heart Failure1Lower-risk Myelodysplastic1Acute Schizophrenia1Schizophrenia1Lupus Nephritis1Migraine Disorders1Alzheimer Disease1
04

By trial register

RegisterTrialsRecruiting
Clinical trials in Japan149

A trial with sites in more than one country appears in each of those registers.

05

Other sponsors in Atopic Dermatitis (AD)

SponsorTrials
Enveda Therapeutics1

Sponsors with the most current trials registered for this condition.

06

Questions about Otsuka Pharmaceutical trials

How many clinical trials does Otsuka Pharmaceutical sponsor?

Otsuka Pharmaceutical is the lead sponsor of 14 current trials on ClinicalTrials.gov in our Japan register, as of the registry sync on 28 September 2026. Completed and withdrawn studies are not counted.

Are Otsuka Pharmaceutical trials recruiting?

Yes. 9 of its 14 ClinicalTrials.gov trials are recruiting. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Which drugs is Otsuka Pharmaceutical testing?

Its current trials name 9 drugs and biologicals as interventions. The most frequent are EB-1020 (Centanafadine) (4), Difamilast (2), Brexpiprazole (1), Decitabine (1) and Fremanezumab (1). The number in brackets is how many of its trials name each drug.

Where does this information come from?

Every trial, status, phase and condition on this page is copied from public ClinicalTrials.gov and EU CTIS records by a daily sync, grouped by the sponsor name each registry records. It says nothing about the organisation beyond its registered trials, and it is not medical advice.

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How this page is built

Everything on this page is copied from public registry records — it is not written from memory, and nothing here describes the organisation beyond its registered trials. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our trial registers and groups every current trial by its lead sponsor name, ignoring legal-form suffixes such as Inc. or Ltd. A small, hand-checked list joins the same organisation's different registry names (for example its EU legal entity). There is no AI drafting and no per-sponsor editorial pass. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The the registries data on this page was last retrieved on 28 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.