Organization (Industry)
Otsuka Pharmaceutical Development & Commercialization, Inc. (United States)
ClinicalTrials.gov lists Otsuka Pharmaceutical Development & Commercialization, Inc. (United States) as lead sponsor of 292 trials. It has 191 active development programs and 40 approved assets.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 14 registered with a 2026 start date. The hollow diamonds on the dashed line are a forecast of the full-year count, planned starts included: about 15 in 2026 and about 13 in 2027, the average of the 24 months through September, counted as registered and carried forward. The columns, the lighter one included, count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. This method has not been backtested on organizations. In backtests on conditions with as many trial starts a year as this organization (5 to 20), forecasts made part-way through the year were typically off by about 28 percent and ran about 20 percent low against the count later registered; forecasts made before the year began were off by about 39 percent and ran about 37 percent low against the count later registered. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.
This page covers Otsuka Pharmaceutical Development & Commercialization, Inc. (United States): 292 lead-sponsored trials and 1 legal-entity registration.
Disease areas (103)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Schizophrenia | 88 |
| Major Depressive Disorder | 36 |
| Attention Deficit Disorder with Hyperactivity | 21 |
| Bipolar Disorder | 16 |
| Psychotic Disorders | 15 |
Showing 5 of 103 disease areas.
Trials by start year as sponsor or collaborator (27)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2026 (partial year) | 14 |
| 2025 | 11 |
| 2024 | 5 |
| 2023 | 9 |
| 2022 | 24 |
| 2021 | 6 |
| 2020 | 10 |
| 2019 | 21 |
| 2018 | 10 |
| 2017 | 13 |
Showing 10 of 27 years.
Prediction, not a registry value: median of 36 months from start to primary completion across 11 trials still running at the 2026-10-09 snapshot; registered median of 20 months across 266 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (191)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| SEP-363856 | Anxiety Disorders | Phase 3 | 4 |
| SEP-363856 | Generalized Anxiety Disorder | Phase 3 | 4 |
| Repinatrabit | Phenylketonurias | Phase 3 | 3 |
| Sibeprenlimab | Glomerulonephritis, IGA | Phase 3 | 3 |
| SEP-363856 | Schizophrenia | Phase 3 | 15 |
Showing 5 of 191 active programs.
Approved assets (40)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Aripiprazole | 63 |
| Brexpiprazole | 41 |
| Olanzapine | 2 |
| Lamotrigine + Aripiprazole | 1 |
| Quetiapine or Risperidone + Aripiprazole | 1 |
Showing 5 of 40 approved assets.
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 57% hit target (n=90) | 40% on time (n=87) |
Journals published in (106)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| The Journal of clinical psychiatry | 23 |
| The New England journal of medicine | 12 |
| Current medical research and opinion | 9 |
| The international journal of neuropsychopharmacology | 8 |
| Journal of child and adolescent psychopharmacology | 7 |
Showing 5 of 106 journals.
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 1 | 1 | 2022-10-18 |
Financing and grant events (1)
| Date | Round type | Amount (USD) | Source |
|---|---|---|---|
| 2020-09-22 | NIH grant | 4,023,155 | Reporter |
FDA untitled letters (1)
| Issue date | Letter |
|---|---|
| 2023-10-31 | 173730 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 16 |
FDA recalls (2)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Kit Contents: 2 packs ABILIFY Tablets 10mg (14 day supply) plus 1 ABILIFY MAINTENA Pre-filled Dual Chamber Syringe Kit. Rx only. Not for sale or reimbursement. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850. Marketed by: Deerfield, IL 60015 USA. Bar Code DCSKit-59148-10Tabs-01 | Class III | 2018-09-17 |
| treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Kit contents 2 packs Abilify Tablets 10 mg (14 day supply) plus 1 Abilfy Maintena Vial Kit.Rx only. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850 USA Marketed by: Lundbleck, Deerfield, IL 60015 USA Bar Code VialKit-59148-10Tabs-02 | Class III | 2018-09-17 |
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 1 | 2005-09-08 |
Organization relationships (48)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Otsuka (Japan) | Co sponsors trial with | 11 |
| H. Lundbeck A/S | Co sponsors trial with | 8 |
| Government of the United States of America | Co sponsors trial with | 4 |
| Michigan Medicine | Co sponsors trial with | 3 |
| Iqvia Holdings Inc. | Uses vendor | 3 |
Showing 5 of 48 relationships.
Latest dated events (341)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-12-15 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-10-06 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-09-30 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-09-15 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-09-01 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
Showing 5 of 341 events.
Biomarker capability evidence (470)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| ACE | Trial sponsor | Named in trial inclusion criteria |
| AGT | Trial sponsor | Named in trial inclusion criteria |
| ALB | Trial collaborator | Named in trial inclusion criteria |
| ALB | Trial sponsor | Named in trial inclusion criteria |
| ALB | Trial collaborator | Named in trial inclusion criteria |
Showing 5 of 470 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, sec-reported annual financials, fda warning letters, manufacturing and distribution sites, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.