Organization (Industry)
Otsuka Pharmaceutical (Spain)
ClinicalTrials.gov lists Otsuka Pharmaceutical (Spain) as lead sponsor of 189 trials, counting the companies grouped under it. Otsuka Pharmaceutical (Spain) itself has 53 active development programs and 18 approved assets.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. Companies grouped under this one are not included. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 2 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 3 in 2026 and about 6 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.
Logo Otsuka Holdings, via Wikimedia Commons, Public domain. Shown to identify the organization; it may be a registered trademark.
This page covers Otsuka Pharmaceutical (Spain) and 1 company grouped under it: 189 lead-sponsored trials (144 its own, 45 in the grouped companies) and 11 legal-entity registrations (10 its own, 1 in the grouped companies).
Related companies are recorded in the same corporate group by GLEIF, ROR or a curator but are not grouped here; they are listed below with their own counts and are not included in the figures above.
Companies grouped under this page (1)
| Company | Lead trials | Legal entities |
|---|---|---|
| Astex Pharmaceuticals | 45 | 1 |
Disease areas (162)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Schizophrenia | 43 |
| Leukemia, Myeloid, Acute | 24 |
| Major Depressive Disorder | 22 |
| Lymphoma | 18 |
| Heart Failure | 17 |
Showing 5 of 162 disease areas.
Trials by start year as sponsor or collaborator (25)
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) | 2 |
| 2025 | 11 |
| 2024 | 1 |
| 2023 | 8 |
| 2022 | 6 |
| 2021 | 5 |
| 2020 | 3 |
| 2019 | 11 |
| 2018 | 8 |
| 2017 | 12 |
Showing 10 of 25 years.
Prediction, not a registry value: median of 36 months from start to primary completion across 7 trials still running at the 2026-10-09 snapshot; registered median of 19 months across 132 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (53)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| OPA-15406 | Dermatitis, Atopic | Phase 3 | 5 |
| EB-1020 (Centanafadine) 164.4 mg | Attention Deficit Disorder with Hyperactivity | Phase 3 | 2 |
| EB-1020 (Centanafadine) low dose | Attention Deficit Disorder with Hyperactivity | Phase 3 | 2 |
| EB-1020 (Centanafadine) high dose | Attention Deficit Disorder with Hyperactivity | Phase 3 | 2 |
| EB-1020 (Centanafadine) 328.8 mg | Attention Deficit Disorder with Hyperactivity | Phase 3 | 2 |
Showing 5 of 53 active programs.
Approved assets (18)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Aripiprazole | 10 |
| Tolvaptan | 5 |
| Rebamipide | 3 |
| Cilostazol | 3 |
| Aspirin | 2 |
Showing 5 of 18 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 |
|---|---|
| 81% hit target (n=42) | 57% on time (n=44) |
Journals published in (167)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| The Journal of clinical psychiatry | 25 |
| Journal of clinical psychopharmacology | 9 |
| The New England journal of medicine | 9 |
| The American journal of psychiatry | 8 |
| BMC psychiatry | 7 |
Showing 5 of 167 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 |
|---|---|---|
| 898 | 110 | 2025-12-09 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 30 |
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 21 | 2025-09-23 |
Manufacturing and distribution sites (7)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Otsuka Pharmaceutical Co., Ltd. | Kanzaki-gun, JP | FDA, Health Canada | |
| Otsuka Pharmaceutical Co Ltd | Naka-gun, JP | FDA, Health Canada | |
| Otsuka Pharmaceutical Co Ltd | Tokushima, JP | EMA, FDA, Health Canada | |
| Otsuka Pharmaceutical Co Ltd | Itano-gun, JP | EMA, FDA, Health Canada | |
| Otsuka Pharmaceutical Co Ltd | Tokushima, JP | EMA, FDA, Health Canada |
Showing 5 of 7 sites.
Organization relationships (46)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| M.D. Anderson Cancer Center | Co sponsors trial with | 9 |
| H. Lundbeck A/S | Co sponsors trial with | 3 |
| Government of the United States of America | Co sponsors trial with | 2 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Co sponsors trial with | 2 |
| UCB Japan Co. Ltd. | Co sponsors trial with | 2 |
Showing 5 of 46 relationships.
Latest dated events (1,321)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-12 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-09 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-03-20 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-12-22 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-12-09 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 1,321 events.
Biomarker capability evidence (214)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| ALB | Trial collaborator | Named in trial inclusion criteria |
| ALK | Trial collaborator | Named in trial inclusion criteria |
| ATP12A | Trial sponsor | Named in trial inclusion criteria |
| ATP4A | Trial sponsor | Named in trial inclusion criteria |
| BRAF | Trial collaborator | Named in trial inclusion criteria |
Showing 5 of 214 evidence rows.
On Scientist.com
Otsuka Pharmaceutical (Spain) is listed as a research supplier in the Scientist.com network.
Service areas
Otsuka offers intravenous solutions, cardiac stents, clinical nutrition, and therapeutic drug products and solutions.
- Website
- www.otsuka-us.com
Not on this page
Checked, with nothing recorded for this organization: sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, fda recalls, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.
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