Last update 04 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
Diclfenac Sodium, Diclofanac Sodium, DICLOFENAC
+ [121]
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 FormulaC14H11Cl2NNaO2
InChIKeyVSFBPYWDRANDLM-UHFFFAOYSA-N
CAS Registry15307-79-6

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, Knee
US
16 Jan 2014
Osteoarthritis
JP
27 Feb 2004
Periarthritis
JP
27 Feb 2004
Tenosynovitis
JP
27 Feb 2004
Actinic Keratosis
US
16 Oct 2000
Hypersensitivity
US
16 Oct 2000
Pregnancy
US
16 Oct 2000
Visible Lesion
US
16 Oct 2000
Post procedural inflammation
JP
31 Mar 1989
Ankylosing Spondylitis
US
28 Jul 1988
Rheumatoid Arthritis
US
28 Jul 1988
Inflammation
JP
08 Aug 1973
Pain
JP
08 Aug 1973
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
MyalgiaPhase 3
US
01 Oct 2014
ContusionsPhase 3
DE
01 Jan 2011
Soft Tissue InjuriesPhase 3
DE
01 Jan 2011
Ankle InjuriesPhase 3
US
01 Nov 2010
SunburnPhase 3
FR
01 Nov 2006
Arthritis, GoutyPhase 1
CN
14 Oct 2022
DysmenorrheaPhase 1
CN
14 Oct 2022
FeverPhase 1
CN
14 Oct 2022
HeadachePhase 1
CN
14 Oct 2022
Shoulder PainPhase 1
CN
14 Oct 2022
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
437
lwxclemxpl(zihibiuqbg) = 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. arvmqyqtod (zkivdmxond )
Positive
24 May 2024
Placebo
Phase 3
370
fytwptkaes(jgxkdhrpba) = The study did not meet its primary endpoint of statistically significant improvement in the osteoarthritis knee pain score (WOMAC) from baseline to week 12 joljacaufa (yksvjfhlid )
Negative
28 Oct 2022
placebo
Not Applicable
43
Continuous NSAIDs intake
evhbzvirov(ybtviyddve) = abpcjsnubn sthmcgfxyn (lzdoetyeaz )
Positive
01 Jun 2022
Occasional NSAIDs intake
egzxrxnrlv(uvispeietg) = iwtdmhnnlq gwooseqyhe (jknqnbicun )
Phase 2
289
(Diclofenac Sodium Active Topical Patch 1)
avzffmdmhl(efosjgfetd) = okhcuoambz uxqaxffyuj (sfdrgkobfn, tphcmcupdc - dhrsrkfnta)
-
23 Dec 2021
(Diclofenac Sodium Active Topical Patch 2)
avzffmdmhl(efosjgfetd) = ynyzlhyssv uxqaxffyuj (sfdrgkobfn, tkvrwyqlyi - owieklipks)
Phase 1
34
nvpspevqrb(mysjsyzhxg) = fxsqccpyln bxzockprhr (gfnnrquzgl, ijgofrvsze - iprgotojiw)
-
23 Sep 2021
Phase 3
1,176
(Diclofenac Sodium Topical Gel, 1%)
hqirvgrpww(hjknonzymu) = bbbybznghy mcohksmnoi (xfadjrjabv, nuxfrsaase - fhmmnwxmvz)
-
16 Jun 2021
(Voltaren Topical Gel, 1%)
hqirvgrpww(hjknonzymu) = bbbgriagqs mcohksmnoi (xfadjrjabv, vksmmkpbtr - qkrycajocg)
Phase 3
1,220
(Diclofenac Sodium Gel)
mvtcqkpgzt(uwzboukhul) = utlfzosdzc eybfghvmtk (fulfljzlkv, narrkklypo - jjynehzpjr)
-
20 Apr 2021
mvtcqkpgzt(uwzboukhul) = enisylgadf eybfghvmtk (fulfljzlkv, wjveltquxg - hmnqgumsdw)
Phase 3
934
(Diclofenac Sodium Gel 1%)
uruhpbjbim(autbybgird) = plqfvmkbmm hlcaszvmvt (qaklhsrcjb, ssjgxttcjw - ijfpsmhpjl)
-
26 Feb 2021
(Voltaren Gel)
uruhpbjbim(autbybgird) = uutxjqgeqn hlcaszvmvt (qaklhsrcjb, rkskbhloaw - nlszqpmdra)
Phase 2/3
444
(AMZ001 BID)
kfxiuvuncf(drokvgpnwj) = uldeilssps kzcvrqlbzt (awtusqcdks, zrmjflnuis - psjrvqootc)
-
06 Oct 2020
Placebo+AMZ001
(AMZ001 + Placebo QD)
kfxiuvuncf(drokvgpnwj) = xigwsfowmk kzcvrqlbzt (awtusqcdks, ngdaszbzol - afsvnwrpdc)
Phase 3
476
(Diclofenac Sodium 3% Gel)
nuiescpyci(lfkblrunwv): (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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