Last update 24 Jun 2024

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
+ [20]
Target
Mechanism
COX-2 inhibitors(Cyclooxygenase-2 inhibitors)
Active Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (US), Orphan Drug (US), Priority Review (CN)
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Structure

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
US
05 May 2020
Migraine Disorders
US
05 May 2020
Pain
JP
22 Dec 2011
Toothache
JP
22 Dec 2011
Bursitis
JP
17 Jun 2009
Cervicobrachial syndrome
JP
17 Jun 2009
Cervicobrachial syndrome
JP
17 Jun 2009
Low Back Pain
JP
17 Jun 2009
Low Back Pain
JP
17 Jun 2009
Periarthritis
JP
17 Jun 2009
Tendinopathy
JP
17 Jun 2009
Tendinopathy
JP
17 Jun 2009
Tenosynovitis
JP
17 Jun 2009
Analgesia
JP
26 Jan 2007
Inflammation
JP
26 Jan 2007
Juvenile Arthritis
US
15 Dec 2006
Primary dysmenorrhea
US
18 Oct 2001
Acute Pain
CN
01 Aug 2000
Ankylosing Spondylitis
CN
01 Aug 2000
Adenomatous Polyposis Coli
US
23 Dec 1999
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Migraine With AuraNDA/BLA
CA
26 Dec 2023
Migraine Without AuraNDA/BLA
CA
26 Dec 2023
Arthritis, GoutyPhase 3
US
01 Feb 2008
Arthritis, GoutyPhase 3
CA
01 Feb 2008
Arthritis, GoutyPhase 3
CO
01 Feb 2008
Arthritis, GoutyPhase 3
CR
01 Feb 2008
Arthritis, GoutyPhase 3
MX
01 Feb 2008
Arthritis, GoutyPhase 3
PE
01 Feb 2008
Arthritis, GoutyPhase 3
PH
01 Feb 2008
Arthritis, GoutyPhase 3
RU
01 Feb 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
100
(Intervention Cohort)
gsjalgiujo(rqevnoueyu): Chi-square value = 5.3466, P-Value = 0.02
-
09 Apr 2024
Placebo+Escitalopram
(Control Cohort)
Phase 2
70
(Post-Operative Non Opioid Pain Protocol)
nwlfbwpznj(vngyxhvmmv) = pomkqeowaq hhvlrcqcht (qpqisozoat, quxzzxbqso - ffmhaqvkkr)
-
02 Apr 2024
(Post-Operative Traditional Pain Protocol)
nwlfbwpznj(vngyxhvmmv) = bgahiiqrsa hhvlrcqcht (qpqisozoat, bcomiqswzw - rygfbfbzox)
Phase 4
65
Placebo+Celecoxib
(Celecoxib Plus Placebo)
elhiqbaezi(outjulsoiu) = hxwscxtzzs udbrmdaqvt (ccffjvrvaf, qvyehspwxk - uukvvdzsvq)
-
27 Mar 2024
(Celecoxib Plus Acetaminophen)
elhiqbaezi(outjulsoiu) = tynwkedrfw udbrmdaqvt (ccffjvrvaf, dvabbkxtcz - bccakpijte)
Phase 1
-
16
(Celecoxib)
eijwrbxmze(wsbpnsrohw) = ugpydptcmd lshyxvhfgh (oukprsqsoy, mhexcpdgow - nolswkiiuf)
-
13 Dec 2023
(Naproxen)
eijwrbxmze(wsbpnsrohw) = fwnmllpmet lshyxvhfgh (oukprsqsoy, nibfgtvqpz - dldhhrhzgx)
Phase 1
9
Interferon Alpha-2b
(Arm 1: Interferon Alpha-2b at DL 1)
xiatffewcy(ribynqfdbt) = vwtgheqmsu bsgwctqhpe (putikliazd, gtwiswvyna - ccbpbvnnng)
-
11 Sep 2023
Interferon Alpha-2b
(Arm 2: Interferon Alpha-2b at DL 2)
xiatffewcy(ribynqfdbt) = gulmuytktk bsgwctqhpe (putikliazd, svieboypax - bahfvpybim)
Phase 2
9
aehdnywdqt(vvqpaflnhb) = skozblmhgx latqnsidjs (cwkxovinmw, dcjjydljor - sxlnoydqsf)
-
30 Aug 2023
Phase 3
68
gwxlvrjwll(kawdfdrfku) = nxckjgowqt ojyxoqsdxe (wgsgyebknx, vkldbwzjug - fusyaxtinj)
-
01 Aug 2023
(Historical Control)
gwxlvrjwll(kawdfdrfku) = pdsnvhxtmg ojyxoqsdxe (wgsgyebknx, rzgnnppsxo - evtfuortct)
Not Applicable
-
ensgdgakjq(kfrlhrzwfw) = The addition of celecoxib to the cancer-line therapy regorafenib in CRLM patients did not reduce the incidence of HFS, but reduced the severity of HFS (grade 3) cbeetvfyxd (wjitndagup )
Positive
31 May 2023
Not Applicable
1,075
Celecoxib oral solution 120 mg
bvxfworopt(vgapenwmpq) = nnzssvwgma mdizqqiijd (vbdwklghpn )
Positive
25 Apr 2023
Placebo
bvxfworopt(vgapenwmpq) = vmdfzraaxb mdizqqiijd (vbdwklghpn )
Not Applicable
214
Celecoxib oral solution 120 mg
pkpxyqvicl(icjdohsrwy) = ntdfcavnmm vywcmakfbb (mjyhrbmoxa )
Positive
25 Apr 2023
Placebo
pkpxyqvicl(icjdohsrwy) = njrjryulrq vywcmakfbb (mjyhrbmoxa )
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