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 1 of 5

RECRUITING Phase 1

A Trial to Assess How Centanafadine Interacts With Stimulants in the Body

NCT07314333

RECRUITING Phase 3

A Study to Evaluate the Safety and Efficacy of JNT-517 in Participants With Phenylketonuria (PKU)

NCT06971731

RECRUITING Phase 3

A Long-Term Study of JNT-517 in Participants With Phenylketonuria

NCT06628128

RECRUITING Phase 2

A Phase 2 Study of JNT-517 in Adolescent Participants With Phenylketonuria

NCT06637514

RECRUITING Phase 3

P3b Short-term Study of CTN in Patients With ADHD and Comorbid Anxiety

NCT06973577

RECRUITING Phase 3

A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

NCT06894212

RECRUITING Phase 2

Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue

NCT06740526

RECRUITING Phase 3

A Study to See Iftolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old withAutosomal Recessive Polycystic Kidney Disease (ARPKD)

NCT04782258

ACTIVE NOT RECRUITING Phase 2

A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's

NCT06928142

ACTIVE NOT RECRUITING Phase 1

First-in-Human, Multiple Part Clinical Study of JNT-517 in Healthy Participants and in Participants With Phenylketonuria

NCT05781399

ACTIVE NOT RECRUITING Phase 3

Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)

NCT05248646

ACTIVE NOT RECRUITING Phase 3

A Trial of Centanafadine Long-term Safety in Children and Adolescents With Attention-deficit/Hyperactivity Disorder.

NCT05279313

NOT YET RECRUITING Phase 1

A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults

NCT07455084

COMPLETED Phase 1

A Trial to Test the Effects of Other Drugs on SEP-380135 in Healthy Men and Women

NCT07305779

COMPLETED Phase 1

A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive Episode

NCT07549581

COMPLETED Phase 1

A Trial to Characterize Differences in Blood Levels of Different Lots of Centanafadine QD XR and to Understand the Effect of Food on Blood Levels

NCT07253441

COMPLETED Phase 1

How [14C]-JNT-517 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Healthy Male Participants

NCT07573449

COMPLETED Phase 1

A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Adult Participants

NCT06212804

COMPLETED Phase 1

A Study to Detect Radioactivity of [14C]-OPC-167832 in Urine and Feces in Healthy Men

NCT07314320

COMPLETED NA

A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion

NCT06372210

COMPLETED Phase 1

A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia

NCT05848700

COMPLETED Phase 3

An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication

NCT05741528

COMPLETED Phase 1

Trial to Demonstrate the Equivalence of Two Different Strengths of Oral Centanafadine Capsules in Healthy Subjects

NCT07486895

COMPLETED Phase 2

A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder

NCT05729373

COMPLETED Phase 3

A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication

NCT05628103

COMPLETED Phase 1

A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia

NCT05542264

COMPLETED Phase 2

A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder

NCT05593029

COMPLETED Phase 1

A Trial to Compare the Amount of Centanafadine That Enters the Bloodstream for Two Different Formulations of Centanafadine

NCT07465731

COMPLETED Phase 1

A Study to Test the Effects of Itraconazole and Carbamazepine on OPC-167832 in Healthy Men and Women

NCT07542847

COMPLETED Phase 2

Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder

NCT05536414

TERMINATED Phase 1

A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline

NCT05189977

COMPLETED Phase 1

A Clinical Study That Will Assess the Effect of SEP-363856 and Prior Antipsychotic (PA) Standard of Care on Glucose and Regulation of Insulin in Patients With Schizophrenia

NCT05463770

COMPLETED Phase 3

A Trial of Centanafadine Efficacy and Safety in Children With Attention-deficit/ Hyperactivity Disorder (ADHD)

NCT05428033

COMPLETED Phase 1

A Clinical Study That Will Assess How Food Moves Through the Stomach and Effects Blood Glucose Levels in Subjects With Schizophrenia Taking SEP-363856 or and Prior Antipsychotic (PA) Standard

NCT05402111

COMPLETED Phase 3

A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder

NCT05257265

COMPLETED Phase 2

A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder

NCT05113953

COMPLETED Phase 2

Efficacy of Centanafadine SR as a Potential Smoking Cessation Treatment

NCT05066724

COMPLETED Phase 1

A Clinical Trial Study to Determine the Effect of an Investigational Drug (SEP-363856) Has on the Way That the Drug Metformin Travels Through the Body in People With Schizophrenia.

NCT04865835

COMPLETED Phase 1

A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention-deficit Hyperactivity Disorder

NCT04786730

COMPLETED NA

Trial to Evaluate the Effectiveness of a Digital Therapeutics in Adults Diagnosed With Major Depressive Disorder

NCT04770285

TERMINATED Phase 3

Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

NCT04464564

COMPLETED Phase 2

Safety and Efficacy Study of VIS649 for IgA Nephropathy

NCT04287985

TERMINATED Phase 3

Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

NCT04408755

COMPLETED Phase 1

A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults With Schizophrenia.

NCT04369391

COMPLETED Phase 1

A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine in Pediatric Subjects With Attention-deficit/Hyperactivity Disorder

NCT04398225

TERMINATED Phase 2

Efficacy and Safety of Oral OPS-2071 in Participants With Crohn's Disease Showing Symptoms of Active Inflammation

NCT03850509

COMPLETED Phase 1

A Single-blind, Placebo-controlled, Outpatient Trial to Assess the Effects of Single Oral Tablet Dose of OPC-214870

NCT04241965

COMPLETED Phase 3

Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148

NCT04258839

COMPLETED Phase 2

Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD)

NCT04186403

COMPLETED Phase 3

A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.

NCT04115319

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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.