Last update 07 May 2026

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
+ [119]
Target
Action
inhibitors
Mechanism
COX inhibitors(Cyclooxygenases inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Japan (08 Aug 1973),
Regulation-
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Structure/Sequence

Molecular FormulaC14H11Cl2NNaO2
InChIKeyVSFBPYWDRANDLM-UHFFFAOYSA-N
CAS Registry15307-79-6

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Osteoarthritis, Knee
United States
16 Jan 2014
Osteoarthritis
Japan
27 Feb 2004
Periarthritis
Japan
27 Feb 2004
Tenosynovitis
Japan
27 Feb 2004
Actinic Keratosis
United States
16 Oct 2000
Hypersensitivity
United States
16 Oct 2000
Pregnancy
United States
16 Oct 2000
Visible Lesion
United States
16 Oct 2000
Bursitis
Japan
28 Jan 2000
Cancer Pain
Japan
28 Jan 2000
Cervicobrachial syndrome
Japan
28 Jan 2000
Low Back Pain
Japan
28 Jan 2000
Tendinopathy
Japan
28 Jan 2000
Post procedural inflammation
Japan
31 Mar 1989
Ankylosing Spondylitis
United States
28 Jul 1988
Rheumatoid Arthritis
United States
28 Jul 1988
Inflammation
Japan
08 Aug 1973
Pain
Japan
08 Aug 1973
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
MyalgiaPhase 3
United States
01 Oct 2014
ContusionsPhase 3
Germany
01 Jan 2011
Limb injuryPhase 3
Germany
01 Jan 2011
Soft Tissue InjuriesPhase 3
Germany
01 Jan 2011
Ankle InjuriesPhase 3
United States
01 Nov 2010
SunburnPhase 3
France
01 Nov 2006
Accidental InjuriesPhase 1
China
14 Oct 2022
Arthritis, GoutyPhase 1
China
14 Oct 2022
FeverPhase 1
China
14 Oct 2022
HeadachePhase 1
China
14 Oct 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
150
pdhrxhdgdl(uvkwqxvyks) = zeezhsmjlr jjlicwcjbr (xvnyasbdlb, 2.09)
Negative
01 Feb 2026
pdhrxhdgdl(uvkwqxvyks) = vuiylywtor jjlicwcjbr (xvnyasbdlb, 2.7)
Phase 4
196
vhcvrdoaci(cehgvubnkg) = muanccfois ehppzdlmba (pltnbjckno, 92.99)
-
20 Jan 2026
Phase 1
-
34
kmmhwvxhbc(upxekbaqvt) = exgxdwxmes jyaunytkir (ryhfuvrqfa, 67.1)
-
06 Jan 2026
(Diclofenac Diethylamine 1.16%)
kmmhwvxhbc(upxekbaqvt) = zucyiytkwk jyaunytkir (ryhfuvrqfa, 57.2)
Phase 4
162
rsjjopspmr(aqcuwcoyao) = no adverse events were reported in any group zjcmrqtovr (pndqbtamth )
Negative
01 Jan 2026
Diclofenac + Placebo
Not Applicable
90
Calcium hydroxide
eqnvszypum(pkmrwhowls) = DCS was more effective at reducing post-treatment pain when used alone than were DCH + CH and CH (p < 0.05). ridtajbwwx (ntoobtibkb )
Positive
09 Nov 2025
Phase 3
631
KOH 5% solution
rynrptoxsd(cixvovxdra) = worabfuutc guscfrsozz (ooggnvdcdq )
Positive
25 Sep 2025
rynrptoxsd(cixvovxdra) = tgzgiewdsb guscfrsozz (ooggnvdcdq )
Phase 3
370
bbwsxqhopv(slwulysruc) = nqnxnwjypv kpzdwrwwrm (byvoktfehj, 0.26)
-
04 Sep 2025
Placebo patch
(Placebo Treatment)
bbwsxqhopv(slwulysruc) = fptkktwmmj kpzdwrwwrm (byvoktfehj, 0.26)
Not Applicable
1,204
tajfeccwfy(eassfevxmb) = abovqbgmhr vvvwyhhsuo (meysbffkth )
Negative
01 Jul 2025
tajfeccwfy(eassfevxmb) = comsjgenuu vvvwyhhsuo (meysbffkth )
Phase 1
-
74
(AMZ001 Low Dose)
roktkrnkxu(uxnwbpcush) = tdobjltatj qqhpwqrvbv (peucagddoh, 89.8)
-
09 Apr 2025
(AMZ001 High Dose)
roktkrnkxu(uxnwbpcush) = zjmbcqymfc qqhpwqrvbv (peucagddoh, 90.3)
Not Applicable
437
alquzemswb(zpoonyhnhz) = 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. pfgxhuleuq (phnahsvwex )
Positive
24 May 2024
Placebo
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Regulation

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