Otsuka Pharmaceutical Development & Commercialization

221 total trials 8 currently recruiting 186 completed

Otsuka Pharmaceutical Development & Commercialization sponsors 221 registered US clinical trials on ClinicalTrials.gov, 8 of them currently recruiting, and 186 completed. 119 of these trials are in Phase 3-4 (later-stage) and 97 in Phase 1-2 (earlier-stage). The most-studied condition in this pipeline is Schizophrenia, with 12 trials.

Trial Pipeline

221 total, page 3 of 5

COMPLETED Phase 3

Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease

NCT02251275

COMPLETED Phase 2

Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adults With Schizophrenia On Oral Aripiprazole

NCT02219009

COMPLETED Phase 3

Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress

NCT02196506

COMPLETED Phase 2

A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis

NCT02068352

COMPLETED Phase 1

This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mouth, in People With Narcolepsy-cataplexy. Accepting Both Males and Females Ages of 18 Years to 55 Years. This Study Will be Conducted in the US and Will Require Approximately 13 Weeks Participation.

NCT05015673

COMPLETED

Safety Follow-up Study for Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Previously Participated in a Double-blind Trial of Brexpiprazole or Placebo

NCT02192554

COMPLETED Phase 1

A Phase 1 Study Comparing AVP-786 With AVP-923

NCT02336347

COMPLETED Phase 1

A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Users

NCT02144415

COMPLETED Phase 3

Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

NCT02160145

COMPLETED Phase 4

Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)

NCT02091882

COMPLETED

Open-Label Observational Pilot Study to Evaluate the Pharmacokinetics of Aripiprazole in Subjects With Bipolar 1 Disorder or Schizophrenia

NCT02050854

COMPLETED Phase 3

Brexpiprazole as Adjunctive Therapy With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy

NCT02012218

COMPLETED Phase 3

Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia

NCT02013622

COMPLETED Phase 3

Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms

NCT02013531

COMPLETED Phase 3

Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment

NCT02013609

COMPLETED Phase 2

Study of Flexible Doses of the Triple Reuptake Inhibitor EB-1020 Sustained Release (SR) in the Treatment of Adult Males With Attention-Deficit Hyperactivity Disorder

NCT01939353

COMPLETED Phase 1

Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia

NCT01994473

COMPLETED Phase 3

Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

NCT01922258

COMPLETED Phase 1

PET Trial to Assess the Receptor Occupancy of Brexpiprazole in Adult Subjects With Schizophrenia

NCT01854944

COMPLETED Phase 1

A Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia

NCT01940159

COMPLETED Phase 3

A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation

NCT01862640

COMPLETED Phase 1

Safety and Tolerability Study of Aripiprazole IM Depot in Adult Subjects With Schizophrenia

NCT01909466

COMPLETED Phase 3

Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia

NCT01683058

COMPLETED Phase 3

Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

NCT01727713

COMPLETED Phase 3

A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial

NCT01727726

COMPLETED Phase 3

Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder

NCT01710709

COMPLETED Phase 3

Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

NCT01727700

COMPLETED Phase 3

Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia

NCT01668797

COMPLETED Phase 3

Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia

NCT01663532

COMPLETED Phase 1

A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis

NCT01702181

COMPLETED Phase 3

Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients

NCT01567527

COMPLETED Phase 1

Phase 1 Study to Assess the Safety/Tolerability of Brexpiprazole as Adjunctive Therapy in Elderly Subjects With Major Depressive Disorder

NCT01670279

COMPLETED Phase 1

A Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once Daily OPB-111077 in Subjects With Advanced Cancer

NCT01711034

COMPLETED Phase 1

An Open Label Study of Aripiprazole Intramuscular Injection in Subjects With Schizophrenia

NCT01646827

COMPLETED Phase 1

Safety and Tolerability Trial of Aripiprazole IM Depot Treatment in Adult Subjects With Schizophrenia Stabilized on Oral Antipsychotics Other Than Aripiprazole

NCT01552772

TERMINATED Phase 1

Ascending Dose Study of OPC-108459 Intravenous Infusions in Patients With Paroxysmal and Persistent Atrial Fibrillation

NCT01483183

COMPLETED Phase 3

Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

NCT01416441

COMPLETED Phase 3

Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)

NCT01360866

COMPLETED Phase 2

8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

NCT01451827

COMPLETED Phase 3

Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia

NCT01397786

COMPLETED Phase 3

Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole

NCT01432444

COMPLETED Phase 3

Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder (TD)

NCT01418352

COMPLETED Phase 3

Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

NCT01418339

COMPLETED Phase 3

Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia

NCT01393613

COMPLETED Phase 3

Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia

NCT01396421

COMPLETED Phase 1

Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder

NCT01423916

COMPLETED Phase 3

Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia

NCT01149655

COMPLETED Phase 3

Study of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Pyxis Trial)

NCT01360645

COMPLETED

Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease

NCT01430494

COMPLETED Phase 3

Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)

NCT01360632

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Phase Distribution

PhaseTrial count
Phase 1 52
Phase 2 45
Phase 3 109
Phase 4 10

What the Pipeline for Otsuka Pharmaceutical Development & Commercialization Shows

According to the ClinicalTrials.gov registry, Otsuka Pharmaceutical Development & Commercialization is linked to 221 US clinical trials across every stage of research activity. Of those, 8 studies are currently recruiting, about 4% of the sponsor's indexed portfolio, and 186 are already marked complete, representing roughly 84% of the total.

The phase mix for Otsuka Pharmaceutical Development & Commercialization reports 119 late-stage studies (Phase 3 and Phase 4 combined) and 97 earlier-phase studies (Phase 1 and Phase 2).

The top therapeutic focus area indexed for Otsuka Pharmaceutical Development & Commercialization is Schizophrenia with 12 linked trials, and 9 other condition areas appear in the top list above.

How to read these pipeline numbers

Recruiting share is one of the more practical signals here: it reflects how much of a sponsor's research is presently open to new participants, while the completed share indicates the depth of finished work that has already contributed registry results. Both counts come directly from the public ClinicalTrials.gov dataset and are refreshed on the registry side; this page mirrors the latest data pull without altering it.

A portfolio weighted toward Phase 3 usually reflects an organization advancing candidates toward regulatory review, where the research centers on comparative efficacy and broader safety across larger populations. A heavier Phase 1 and Phase 2 tilt generally indicates exploratory work, safety, dosing, and early signal detection, and is common among research-forward sponsors that seed many early programs. Phase 4 entries, when present, track interventions already in real-world use and typically focus on long-term safety, effectiveness across subgroups, or formulation comparisons.

That distribution is a quick read of where the organization concentrates its research attention; it does not imply product availability, market share, or any clinical endorsement. All numbers on this page come from ClinicalTrials.gov maintained by the National Library of Medicine, and counts can shift as new studies are registered or existing ones update their status. This information is provided for reference and educational purposes only, not as medical, investment, or regulatory advice, verify current details directly with ClinicalTrials.gov before relying on any figure here.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial from this sponsor, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.