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.
openfdaProvenance
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-04
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260908-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | VYSCOXA contains celecoxib, a nonsteroidal anti-inflammatory drug, and is indicated: In adults for • Osteoarthritis (OA) • Rheumatoid Arthritis (RA) • Ankylosing Spondylitis (AS) • In pediatric patients two years and older for • Juvenile Rheumatoid Arthritis (JRA) • Limitations of Use VYSCOXA must be administered on an empty stomach at least 2 hours before or 1 hour after food. Taking VYSCOXA with food results in plasma exposures of celecoxib up to 50% higher than intended. If patients cannot tolerate VYSCOXA in the fasted state, discontinue use of VYSCOXA ( 2.1 , 5 , 12 ) | approved | Jul 29, 2025 | openfda |
| US FDA | — | ELYXYB is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use ELYXYB is not indicated for the preventive treatment of migraine. ELYXYB is a nonsteroidal anti-inflammatory drug indicated for the acute treatment of migraine with or without aura in adults ( 1 ) Limitations of Use ELYXYB is not indicated for the preventive treatment of migraine. ( 1 ) | approved | May 5, 2020 | openfda |
| US FDA | — | Efficacy supplement 2018-06-28 (see label) | approved | Jun 28, 2018 | openfda |
Data updated 2 days 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 |
|---|---|---|---|---|---|---|---|---|
| NCT00005878 | Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus | completed | Phase 2 | — | Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER | 1 | Oct 13, 2016 | clinicaltrials |
| NCT00070486 | Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer | completed |