Last update 21 Nov 2024

Diclofenac Sodium

Overview

Basic Info

SummaryDiclofenac sodium, a benzene-acetic acid derivative, is a nonsteroidal anti-inflammatory drug (NSAID) ,has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of Diclofenac sodium, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). The FDA approved diclofenac sodium as VOLTAREN on July 28, 1988, and its originator was the Ciba-Geigy Corporation, which is now a part of Novartis. This drug has been used for many years to manage a wide range of painful conditions and is widely available in both prescription and over-the-counter formulations.
Drug Type
Small molecule drug
Synonyms
DICLOFENAC, Diclfenac Sodium, Diclofanac Sodium
+ [122]
Target
Mechanism
COX inhibitors(Cyclooxygenases inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
JP (08 Aug 1973),
Regulation-
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Structure

Molecular FormulaC14H11Cl2NO2
InChIKeyDCOPUUMXTXDBNB-UHFFFAOYSA-N
CAS Registry15307-86-5
View All Structures (2)

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Bursitis
JP
20 Jun 2022
Cervicobrachial syndrome
JP
20 Jun 2022
Low Back Pain
JP
20 Jun 2022
Tendinopathy
JP
20 Jun 2022
Cancer Pain
JP
23 Mar 2021
Osteoarthritis
JP
27 Feb 2004
Periarthritis
JP
27 Feb 2004
Tenosynovitis
JP
27 Feb 2004
Post procedural inflammation
JP
31 Mar 1989
Inflammation
JP
08 Aug 1973
Pain
JP
08 Aug 1973
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PainPhase 3
US
16 Jan 2014
Rheumatoid ArthritisPhase 3
US
28 Jul 1988
Ankylosing SpondylitisPreclinical
US
28 Jul 1988
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
437
(rhsnqsrmrb) = 5 pts experienced any grade treatment emergent adverse events (TEAEs). All TEAEs were grade 1-2. TEAE leading to treatment discontinuation was occurred in one pt. pwoasmyvbk (ifwmiskgnk )
Positive
24 May 2024
Placebo
Phase 3
370
(ddwsnombkw) = The study did not meet its primary endpoint of statistically significant improvement in the osteoarthritis knee pain score (WOMAC) from baseline to week 12 xtaktsqcrq (rurfbfammt )
Negative
28 Oct 2022
placebo
Phase 3
40
(kjsepgaige) = fgztwsnlrm dvahzbgwcy (pxvfpcptue )
Positive
09 Oct 2022
(kjsepgaige) = rvmvehrbpk dvahzbgwcy (pxvfpcptue )
Phase 2
289
(Diclofenac Sodium Active Topical Patch 1)
yqmbrmtems(ykxciejvxo) = rrzppxkkly fwtoiibibv (lqgvapovft, vancbqtopw - kqxbfyktbn)
-
23 Dec 2021
(Diclofenac Sodium Active Topical Patch 2)
yqmbrmtems(ykxciejvxo) = zkqwgzrasd fwtoiibibv (lqgvapovft, qeknpxhxxd - thlqjklgsd)
Phase 1
34
tsisrebask(wgwlnuzafl) = mbjqcgwtit rrzirtqrxo (pvmmyhitlh, xbfjtpqhhs - vlknoalrpr)
-
23 Sep 2021
Phase 3
1,176
(Diclofenac Sodium Topical Gel, 1%)
waordvhxwi(luymoxfjfq) = eqeiovfedk cjyrsxohgt (zmjljkrhzu, oanypenzkj - wvzqbjmoxe)
-
16 Jun 2021
(Voltaren Topical Gel, 1%)
waordvhxwi(luymoxfjfq) = takmnkldao cjyrsxohgt (zmjljkrhzu, kyaowtekjm - lufhbyzswg)
Phase 3
1,220
(Diclofenac Sodium Gel)
qvdrjsbslm(xlpomyyxmu) = odivcntfcr ezhyfhfyxv (qooxvvyhwg, dhlkocxryi - tnoqotucgi)
-
20 Apr 2021
qvdrjsbslm(xlpomyyxmu) = lhjvbxgolr ezhyfhfyxv (qooxvvyhwg, gorfvpnnhy - vjojtnqwtu)
Phase 3
934
(Diclofenac Sodium Gel 1%)
hjrypflxoz(aivkiavlof) = dndovtmxfb lwtnywrjxd (haztnqgdox, terajugkam - ixzwfjeyrn)
-
26 Feb 2021
(Voltaren Gel)
hjrypflxoz(aivkiavlof) = wybpmrmhfc lwtnywrjxd (haztnqgdox, ydazjanzbg - kfmuzvzxfz)
Phase 2/3
444
(AMZ001 BID)
xfhbppbefj(lrmcbnbcvy) = lelfgfvcie shylgbnaan (vfdmdlmjrg, enxrozggwc - mztcpugcvs)
-
06 Oct 2020
Placebo+AMZ001
(AMZ001 + Placebo QD)
xfhbppbefj(lrmcbnbcvy) = opcyxkmztd shylgbnaan (vfdmdlmjrg, yggqblqflo - vxgtflsyie)
Phase 3
476
(Diclofenac Sodium 3% Gel)
ehltcwuvxe(iqqrzgpocv): (Test-Ref) Difference = 0.68 (90% CI, -8.06 to 9.42)
-
20 Jul 2020
Solaraze( Diclofenac Sodium)
(Solaraze( Diclofenac Sodium) 3% Gel)
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