Drug · Small Molecule
Celecoxib
CI-DRUG-00000146Explore in graph →NCIt C1728 CHEMBL118 CIViC Approved
Regulatory
Approvals (10)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
emaProvenance
- Source
- EMA — European public assessment reports (centrally authorised medicines)
- Dataset
- EMA medicines data (xlsx)
- Version
- ema-medicines-2026-09-11T06:00
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- EMA copyright — reproduction and distribution permitted for non-commercial and commercial purposes provided EMA is acknowledged as the source (https://www.ema.europa.eu/en/about-us/legal-notice)
- Run
- ING-EMA-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| EU EMA | — | Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4.4). The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1) | withdrawnsince Nov 28, 2008 | Oct 17, 2003 | ema |
Data updated 23 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 15 | 11 | 27 | 192 | 10 | EU, US | Dec 31, 1998 | 1998-03 |
| Malignant Liver Neoplasm | Phase4 | Phase 4 | 1 | 1 | 2 | 6 | 0 | — | — | 2002-10 |
| Malignant Rectal Neoplasm | Phase3 | Phase 3 | 2 | 2 | 1 | 5 | 0 | — | — | 2000-03 |
| Malignant Breast Neoplasm | Phase3 | Phase 3 | 1 | 1 | 3 | 24 | 0 | — |
Curated evidence
Clinical evidence (3)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
civicProvenance
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 28881160
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| CTNNB1 T41A1 | ||||||||
| Celecoxib | Desmoid Fibromatosis | |||||||
Clinical trials
Trials with this intervention (194)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT02429427 | European Celecoxib Trial in Primary Breast Cancer(REACT) | completed | Phase 3 | 2,639 | Imperial College LondonOTHER | 0 | Jun 23, 2020 | clinicaltrials |
| NCT01143545 | Pilot Study of Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers, Thymic Neoplasms, and Malignant Pleural Mesotheliomas |