Otsuka Pharmaceutical Development & Commercialization, Inc. clinical trial failures

Review 31 stopped clinical trials from Otsuka Pharmaceutical Development & Commercialization, Inc., including disease areas, phases, and classified stop reasons.

This page groups real ClinicalTrials.gov-derived stopped trial records. The strongest added signal is the stop-reason classification: 3 of these records are likely biological failure signals, while the rest may reflect operational, strategic, regulatory, funding, enrollment, or unclear stop reasons.

Total stopped trials31

Likely biological signals3

Shown below31

Dominant stop reasons

OPERATIONAL: 17
OTHER/UNKNOWN: 11
EFFICACY/FUTILITY: 3

Notable sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.: 31

Related phases

Phase III: 16
Phase II: 8
Phase I: 4
Phase IV: 3

Crawlable stopped-trial records

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Showing up to 31 representative records from this slice. Each link opens the trial detail page with source attribution and stop-reason context.

NCT02534038: Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition

Phase II Disinhibition Syndrome trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OPERATIONAL.

The study was terminated prematurely because of difficulty with recruiting.

NCT06795399: A Proof-of-concept Trial for OPC 131461 in Patients Hospitalized for Worsening Heart Failure

Phase II Heart Failure trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OTHER/UNKNOWN.

No sites were initiated, no sites were activated, no patients were enrolled in this study.

NCT04786574: A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

Phase III Autosomal Recessive Polycystic Kidney Disease (ARPKD) trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OTHER/UNKNOWN.

Study stopped before enrolling any participants.

NCT02446132: Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Phase III Agitation in Patients With Dementia of the Alzheimer's Type trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OPERATIONAL.

The AVP-786 program was discontinued, the recruitment was stopped and all participants are no longer being examined or receiving intervention.

NCT04464564: 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

Phase III Agitation in Patients With Dementia of the Alzheimer's Type trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OPERATIONAL.

The AVP-786 program was discontinued, the recruitment was stopped and all participants are no longer being examined or receiving intervention.

NCT04408755: Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Phase III Agitation in Patients With Dementia of the Alzheimer's Type trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OPERATIONAL.

The AVP-786 program was discontinued, the recruitment was stopped and all participants are no longer being examined or receiving intervention.

NCT04109950: A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia

Phase III Schizophrenia trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OTHER/UNKNOWN.

Study terminated early, main goals achieved

NCT03896945: Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia

Phase II Schizophrenia trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: EFFICACY/FUTILITY.

Based on the Interim Analysis outcome and recommendation by the DMC, Otsuka approved termination of the study based on futility.

NCT05189977: A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline

Phase I Post-traumatic Stress Disorder (PTSD) trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: EFFICACY/FUTILITY.

The decision to terminate the trial early was not based on safety concerns. The trial was terminated early due to some implausible blood pressure values being captured, which was the primary endpoint of the study.

NCT05504486: Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety

Phase IV Major Depressive Disorder (MDD) trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OPERATIONAL.

Sponsor strategic decision

NCT03420222: Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder

Phase II Intermittent Explosive Disorder trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OPERATIONAL.

Due to limited enrollment (N=10), this clinical trial was terminated by the Sponsor.

NCT02827513: A Phase 1 Study to Investigate the Safety, Tolerance, Food Effect, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of Extended Release Formulations of Centanafadine (CTN) in Young Healthy Subjects

Phase I Adult Attention-deficit Hyperactivity Disorder (ADHD) trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

NCT01123707: To Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

Phase III Major Depressive Disorder (MDD) trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OPERATIONAL.

The study was terminated early due to Sponsor decision; no safety issues.

NCT01111565: Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

Phase III Major Depressive Disorder (MDD) trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OPERATIONAL.

The study was terminated early due to Sponsor decision, closure of this combination therapy program is unrelated to any safety issues, no signals of concern.

NCT01131351: Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis

Phase II Tuberculosis trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: EFFICACY/FUTILITY.

The study was terminated early due to lack of efficacy after 10 participants enrolled.

NCT01111552: Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

Phase III Major Depressive Disorder (MDD) trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OPERATIONAL.

The study was terminated early due to Sponsor decision, closure of this combination therapy program is unrelated to any safety issues, no signals of concern.

NCT01111539: Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

Phase III Major Depressive Disorder (MDD) trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OPERATIONAL.

The study was terminated early due to Sponsor decision, closure of this combination therapy program is unrelated to any safety issues, no signals of concern.

NCT03850509: Efficacy and Safety of Oral OPS-2071 in Participants With Crohn's Disease Showing Symptoms of Active Inflammation

Phase II Crohn's Disease trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OPERATIONAL.

Sponsor Decision

NCT03661983: Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Participants With Tourette's Disorder

Phase IV Tourette's Disorder (TD) trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OPERATIONAL.

Lack of feasibility for completion of the trial within a reasonable time frame.

NCT02020278: An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia

Phase III Hyponatremia trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OPERATIONAL.

Issues with recruitment and enrollment made the trial impossible or highly impracticable. Termination of this trial was not due to safety reasons.

NCT03643159: A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder

Phase IV Schizophrenia trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OPERATIONAL.

Difficulty in participant recruitment

NCT02012959: Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia

Phase III Hyponatremia trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OPERATIONAL.

Issues with participant recruitment \& enrollment which made the trial impossible or highly impracticable. Trial termination was not due to safety reasons.

NCT02968121: Safety and Tolerability Study of Single-dose Administration of Brexpiprazole in Adult Subjects With Schizophrenia

Phase I Schizophrenia trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OTHER/UNKNOWN.

Part A of study was completed per protocol. Conduct of Part B of the study (confirmatory phase) was not necessary.

NCT02442674: A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia

Phase III Hyponatremia trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OTHER/UNKNOWN.

Trial withdrawn due to inability to meet the trial objectives (Pilot).

NCT00874497: Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema

Phase II Chronic Obstructive Pulmonary Disease trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OTHER/UNKNOWN.

Sponsor Terminated

NCT01483183: Ascending Dose Study of OPC-108459 Intravenous Infusions in Patients With Paroxysmal and Persistent Atrial Fibrillation

Phase I Atrial Fibrillation trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OPERATIONAL.

Enrollment Difficulty

NCT02212613: Brexpiprazole (OPC 34712) Trial in the Treatment of Adults With Major Depressive Disorder and Irritability

Phase III Major Depressive Disorder and Irritability trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OPERATIONAL.

Low enrollment

NCT01122927: Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features.

Phase III Adolescent Schizophrenia trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OTHER/UNKNOWN.

The trial was terminated early as the objective of the Aripiprazole Pediatric Investigational Plan was met and provided 2 years of safety data.

NCT02435836: A Follow-on Study of the Long-Term Safety of Aripiprazole in Patients With Chronic Schizophrenia

Phase III Schizophrenia trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OTHER/UNKNOWN.

Study terminated when aripiprazole available commercially per protocol

NCT01981811: Adherence to Treatment, Safety and Tolerability Study of the Medical Information Device #1 (MIND1) in Subjects With Schizophrenia or Bipolar I Disorder

Phase II Bipolar 1 Disorder trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OTHER/UNKNOWN.

The trial was terminated because it was determined that the usability of the MIND1 System in the intended population was necessary before conducting this trial.

NCT01509053: Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole

Phase III Schizophrenia trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.