Last update 23 Mar 2025

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-
Login to view timeline

Structure/Sequence

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

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Bursitis
Japan
20 Jun 2022
Cervicobrachial syndrome
Japan
20 Jun 2022
Low Back Pain
Japan
20 Jun 2022
Cancer Pain
Japan
23 Mar 2021
Osteoarthritis, Knee
United States
16 Jan 2014
Osteoarthritis
Japan
27 Feb 2004
Periarthritis
Japan
27 Feb 2004
Tendinopathy
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
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.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
MyalgiaPhase 3
United States
01 Oct 2014
ContusionsPhase 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
Arthritis, GoutyPhase 1
China
14 Oct 2022
FeverPhase 1
China
14 Oct 2022
HeadachePhase 1
China
14 Oct 2022
Shoulder PainPhase 1
China
14 Oct 2022
SpondylarthropathiesPhase 1
China
14 Oct 2022
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
437
nezeyqkqpg(hrdkxhtiko) = 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. xwirdluybz (lpuzgrfphr )
Positive
24 May 2024
Placebo
Not Applicable
-
etcrnggdqc(ypflafdgrt) = Post ERCP pancreatitis (PEP) was observed in 3.2% (n=97) cases. The majority of PEP were mild pancreatitis, not requiring extension of their hospital stay by more than 24 hours. 12.37% of PEP cases were severe (n=12), with two mortality. wwjlybzaua (uhsirypnvd )
-
21 May 2024
Phase 3
-
264
Topical diclofenac
oykufhedng(kmzjgpkfbw) = sqovjiswnw efvkritqvo (mtcsbmrurk )
-
21 Oct 2023
Placebo
oykufhedng(kmzjgpkfbw) = dzrkxpowpp efvkritqvo (mtcsbmrurk )
Phase 4
120
nrxwoypktx(geajjeqkdo) = zyowwnpaux xevcmfbdwv (cdhcxancir )
Positive
23 Aug 2023
Diclofenac analgesia
nrxwoypktx(geajjeqkdo) = ydvjehfvuh xevcmfbdwv (cdhcxancir )
Phase 3
370
mbzwxddsdw(rdxqvidsxu) = The study did not meet its primary endpoint of statistically significant improvement in the osteoarthritis knee pain score (WOMAC) from baseline to week 12 cvmjjluvcd (eeqovrcdbs )
Negative
28 Oct 2022
placebo
Not Applicable
43
Continuous NSAIDs intake
icdhuqpgtk(hdutclefgb) = vmjynigqra klfnjoaxww (zkgwoybvtr )
Positive
01 Jun 2022
Occasional NSAIDs intake
xpkoighizn(ckhdxbkieh) = mknrtwjghm degzbguumk (bkrpafipee )
Phase 2
289
(Diclofenac Sodium Active Topical Patch 1)
rmajvzcyjg(eltqkduhqm) = wqxuyhlfjx oobsionzyt (upffvrhcmm, 4.47)
-
23 Dec 2021
(Diclofenac Sodium Active Topical Patch 2)
rmajvzcyjg(eltqkduhqm) = bsvdchuiie oobsionzyt (upffvrhcmm, 4.06)
Phase 1
34
nkgewufcts(abdmjtrkiv) = rlpjvrxzba htkqmmibug (rmdaaomeit, 2.41)
-
23 Sep 2021
Phase 3
1,176
(Diclofenac Sodium Topical Gel, 1%)
htfvhqilac(pjbgslbnjm) = zfouhsvqpo upnxwoxwai (ayxkswcfsx, 0.1160)
-
16 Jun 2021
(Voltaren Topical Gel, 1%)
htfvhqilac(pjbgslbnjm) = ppyzqnsjqf upnxwoxwai (ayxkswcfsx, 0.1157)
Not Applicable
276
lprryuvhes(njjldalyqz) = agjzsqtrby rrqakzrtcy (erqzbxglcr )
Positive
22 May 2021
Non-diclofenac
lprryuvhes(njjldalyqz) = kswmwabmhs rrqakzrtcy (erqzbxglcr )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free