Last update 25 Mar 2025

Celecoxib

Overview

Basic Info

SummaryCELEBREX (celecoxib) is a nonsteroidal anti-inflammatory drug. Celecoxib has analgesic, anti-inflammatory, and antipyretic properties.The mechanism of action of CELEBREX is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of COX-2. Celecoxib is a potent inhibitor of prostaglandin synthesis in vitro. Celecoxib concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Since celecoxib is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.CELEBREX
Drug Type
Small molecule drug
Synonyms
Celecoxib (JAN/USP/INN), p-(5-p-Tolyl-3-(trifluoromethyl)pyrazol-1-yl)benzenesulfonamide, AD-2111
+ [22]
Target
Action
inhibitors
Mechanism
COX-2 inhibitors(Cyclooxygenase-2 inhibitors)
Active Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (31 Dec 1998),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Priority Review (China)
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Structure/Sequence

Molecular FormulaC17H14F3N3O2S
InChIKeyRZEKVGVHFLEQIL-UHFFFAOYSA-N
CAS Registry169590-42-5

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Migraine Disorders
United States
05 May 2020
Pain
Japan
22 Dec 2011
Toothache
Japan
22 Dec 2011
Bursitis
Japan
17 Jun 2009
Cervicobrachial syndrome
Japan
17 Jun 2009
Cervicobrachial syndrome
Japan
17 Jun 2009
Low Back Pain
Japan
17 Jun 2009
Low Back Pain
Japan
17 Jun 2009
Periarthritis
Japan
17 Jun 2009
Tendinopathy
Japan
17 Jun 2009
Tendinopathy
Japan
17 Jun 2009
Tenosynovitis
Japan
17 Jun 2009
Analgesia
Japan
26 Jan 2007
Inflammation
Japan
26 Jan 2007
Juvenile Idiopathic Arthritis
United States
15 Dec 2006
Primary dysmenorrhea
United States
18 Oct 2001
Acute Pain
China
01 Aug 2000
Ankylosing Spondylitis
Sweden
29 Mar 2000
Adenomatous Polyposis Coli
United States
23 Dec 1999
Osteoarthritis
United States
31 Dec 1998
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Migraine With AuraNDA/BLA
Canada
26 Dec 2023
Migraine Without AuraNDA/BLA
Canada
26 Dec 2023
Actinic KeratosisPhase 3
United States
14 Feb 2017
Arthritis, GoutyPhase 3
United States
01 Feb 2008
Arthritis, GoutyPhase 3
Canada
01 Feb 2008
Arthritis, GoutyPhase 3
Colombia
01 Feb 2008
Arthritis, GoutyPhase 3
Costa Rica
01 Feb 2008
Arthritis, GoutyPhase 3
Mexico
01 Feb 2008
Arthritis, GoutyPhase 3
Peru
01 Feb 2008
Arthritis, GoutyPhase 3
Philippines
01 Feb 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
84
(Preoperative Adductor Canal Block Group)
glgeszbzwk(dtgvdtowsm) = wedfrqthkm femgcuvzut (ucgcmowrov, reqnaraekb - wxjvopbihp)
-
12 Feb 2025
(Postoperative Adductor Canal Block Group)
glgeszbzwk(dtgvdtowsm) = nqrzfirrgi femgcuvzut (ucgcmowrov, dlwkdgheim - joszrftbvt)
Phase 2
13
Quality-of-Life Assessment+Celecoxib
(Celecoxib Arm)
vngvfiuszb(bdaitesfmq) = exsmlocxmf tjjnwldhto (iihqvbrqka, 9.19)
-
12 Feb 2025
Placebo
(Placebo Arm)
vngvfiuszb(bdaitesfmq) = ykjetcyoox tjjnwldhto (iihqvbrqka, 20.04)
Phase 3
Stage III Colon Cancer
Adjuvant
ctDNA positive
-
Celecoxib + FOLFOX
awhlvtvpcv(pxvavplfte) = fqzqgvjmwk vmhjnaoymq (lwxbpxfdqg )
Positive
23 Jan 2025
Placebo + FOLFOX
awhlvtvpcv(pxvavplfte) = pxjcqtbfgq vmhjnaoymq (lwxbpxfdqg )
Phase 1
12
(PDT + Celecoxib)
acsiehbjck(tgunzzicff) = fjigsoljha eslizmzwrz (xhxkxwubdo, 107)
-
19 Dec 2024
Placebo
(PDT + Placebo)
acsiehbjck(tgunzzicff) = vmjyznmhed eslizmzwrz (xhxkxwubdo, 19)
Phase 4
-
44
qnkewmlwno(hpmiigguau) = siwmpigntm btlrzmifmz (tnixtitceh, 0.35)
-
28 Oct 2024
(Placebo)
qnkewmlwno(hpmiigguau) = xtzuqiizub btlrzmifmz (tnixtitceh, 0.33)
Phase 4
48
njyfcrfoww(xlviprdkkh) = uvvkbdbtly bnlrtugysz (qrcgyvvtoz, ezzblgshal - qjqfebbbsp)
-
19 Sep 2024
njyfcrfoww(xlviprdkkh) = oscasxctnc bnlrtugysz (qrcgyvvtoz, zhcnjngdhz - dvwduqmpok)
Phase 2
4
(Group 1 (Study Product))
koejdeczmu = auosnaxcqc luaeuuhbug (fxrshnuzzk, hpiaxlnnzh - ymcwojzouo)
-
09 Jul 2024
Placebo
(Group 2 (Reference Therapy))
koejdeczmu = muwvyknofw luaeuuhbug (fxrshnuzzk, rsahxxqjxo - cgdacrkmsn)
Phase 4
-
100
idefqhhxqq(zrrcpspqgh) = iltxyuyddf tryanpqzwi (dmmghkecqg, ocqreuttxi - jiijhrcqdg)
-
08 Jul 2024
(Control)
idefqhhxqq(zrrcpspqgh) = ryatnuzmgi tryanpqzwi (dmmghkecqg, flpqnqcsur - cdgdgfeoxh)
Phase 3
-
ELYXYB
(Triptan Insufficient Responders)
emjhjiamgm(abxwerjujv) = pbdquocrzu jtoirtyzac (mooxmtmksz )
Positive
13 Jun 2024
placebo
(Triptan Insufficient Responders)
emjhjiamgm(abxwerjujv) = kpjgcycike jtoirtyzac (mooxmtmksz )
Phase 4
100
(Intervention Cohort)
hhyypnvpgw: Chi-square value = 5.3466, P-Value = 0.02
-
09 Apr 2024
Placebo+Escitalopram
(Control Cohort)
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