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.

emaRegulatory10 approval records from 2 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

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
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 )

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.

civicCuratedShowing 1–3 of 3 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

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.

clinicaltrialsPublishedShowing 151–194 of 194 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT00466505	Cetuximab & Celecoxib for Metastatic Colorectal Cancer or Colorectal Cancer That Cannot Be Removed by Surgery	completed	Phase 2	17	Vanderbilt-Ingram Cancer CenterOTHER	1	Dec 19, 2012	clinicaltrials
NCT00527982	Celecoxib as Adjuvant Biologic Therapy in Patients With Head and Neck and Lung Cancer	terminated	Phase 2

Molecule

Record

Kind: Small Molecule
Mechanism: Cyclooxygenase-2 inhibitor
Targets: 1 gene
UNII: JCX84Q7J1L
Aliases: 4-(5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide, Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebra, Celebrex, CELEBREX, Celecoxib, Celecoxib component of consensi, Celecoxib component of seglentis, DFN-15, DFN15, Elyxyb, ELYXYB - CELECOXIB, NSC-719627, NSC-758624, Onsenal, SC-58635, VYSCOXA, YM 177

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (2)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01XX33	Antineoplastic agents
EMA product	EMEA/H/C/000466	Onsenal

Regulatory status is jurisdiction-specific and time-bound. Nothing on this page is a treatment recommendation.