Organization (Industry)
Ono Pharmaceutical (United States)
ClinicalTrials.gov lists Ono Pharmaceutical (United States) as lead sponsor of 112 trials. It has 113 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: 12 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 13 in 2026 and about 12 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. 2 trials are registered to start in 2027 or later.
Logo Ono Pharmaceutical Co., Ltd., via Wikimedia Commons, Public domain. Shown to identify the organization; it may be a registered trademark.
This page covers Ono Pharmaceutical (United States): 112 lead-sponsored trials and 3 legal-entity registrations.
Disease areas (92)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Lung Neoplasms | 13 |
| Carcinoma, Non-Small-Cell Lung | 10 |
| Stomach Neoplasms | 10 |
| Head and Neck Neoplasms | 8 |
| Kidney Neoplasms | 8 |
Showing 5 of 92 disease areas.
Trials by start year as sponsor or collaborator (26)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 2 trials are registered to start in 2027 or later, and not listed here.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2026 (partial year) | 12 |
| 2025 | 12 |
| 2024 | 5 |
| 2023 | 8 |
| 2022 | 9 |
| 2021 | 11 |
| 2020 | 9 |
| 2019 | 10 |
| 2018 | 8 |
| 2017 | 22 |
Showing 10 of 26 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 17 months across 76 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (113)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| NIVOLUMAB | Stomach Neoplasms | Phase 3 | 6 |
| "Capecitabine" | Stomach Neoplasms | Phase 3 | 5 |
| OXALIPLATIN | Stomach Neoplasms | Phase 3 | 5 |
| S-1 | Stomach Neoplasms | Phase 3 | 2 |
| ONO-2808 | Multiple System Atrophy | Phase 3 | 2 |
Showing 5 of 113 active programs.
Approved assets (40)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Sivelestat | 1 |
| NIVOLUMAB | 25 |
| OXALIPLATIN | 11 |
| "Capecitabine" | 7 |
| FLUOROURACIL | 6 |
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 |
|---|---|
| 62% hit target (n=37) | 64% on time (n=39) |
Journals published in (69)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Journal of clinical oncology : official journal of the American Society of Clinical Oncology | 22 |
| The New England journal of medicine | 20 |
| Journal for immunotherapy of cancer | 13 |
| The Lancet. Oncology | 13 |
| Future oncology (London, England) | 7 |
Showing 5 of 69 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 |
|---|---|---|
| 612 | 36 | 2025-12-16 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 4 |
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 2 | 2024-04-22 |
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Ono Pharmaceutical Co., Ltd. | FUJINOMIYA, JP | EMA, FDA |
Organization relationships (13)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| National Cancer Center, Japan | Co sponsors trial with | 2 |
| Deciphera Pharmaceuticals (United States) | Co sponsors trial with | 2 |
| National Cancer Center Hospital East | Co sponsors trial with | 1 |
| Merck KGaA, Darmstadt (Germany) | Co sponsors trial with | 1 |
| Yale University | Co sponsors trial with | 1 |
Showing 5 of 13 relationships.
Latest dated events (816)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2027-02 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2027-01 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-10-31 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-10 | 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)) |
Showing 5 of 816 events.
Biomarker capability evidence (278)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| ACHE | Trial sponsor | Named in trial inclusion criteria |
| ALB | Trial sponsor | Named in trial inclusion criteria |
| ALB | Trial collaborator | Named in trial inclusion criteria |
| ATP12A | Trial sponsor | Named in trial inclusion criteria |
| ATP4A | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 278 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, 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.