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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date JP (08 Aug 1973), |
Regulation- |
Molecular FormulaC14H11Cl2NO2 |
InChIKeyDCOPUUMXTXDBNB-UHFFFAOYSA-N |
CAS Registry15307-86-5 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Pain | Phase 3 | US | 16 Jan 2014 | |
Rheumatoid Arthritis | Phase 3 | US | 28 Jul 1988 | |
Ankylosing Spondylitis | Preclinical | US | 28 Jul 1988 |
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 | Placebo patch+Diclofenac Sodium Active Topical Patch 1 (Diclofenac Sodium Active Topical Patch 1) | yqmbrmtems(ykxciejvxo) = rrzppxkkly fwtoiibibv (lqgvapovft, vancbqtopw - kqxbfyktbn) View more | - | 23 Dec 2021 | ||
Placebo patch+Diclofenac Sodium Active Topical Patch 2 (Diclofenac Sodium Active Topical Patch 2) | yqmbrmtems(ykxciejvxo) = zkqwgzrasd fwtoiibibv (lqgvapovft, qeknpxhxxd - thlqjklgsd) View more | ||||||
Phase 1 | 34 | tsisrebask(wgwlnuzafl) = mbjqcgwtit rrzirtqrxo (pvmmyhitlh, xbfjtpqhhs - vlknoalrpr) View more | - | 23 Sep 2021 | |||
Phase 3 | 1,176 | (Diclofenac Sodium Topical Gel, 1%) | waordvhxwi(luymoxfjfq) = eqeiovfedk cjyrsxohgt (zmjljkrhzu, oanypenzkj - wvzqbjmoxe) View more | - | 16 Jun 2021 | ||
(Voltaren Topical Gel, 1%) | waordvhxwi(luymoxfjfq) = takmnkldao cjyrsxohgt (zmjljkrhzu, kyaowtekjm - lufhbyzswg) View more | ||||||
Phase 3 | 1,220 | (Diclofenac Sodium Gel) | qvdrjsbslm(xlpomyyxmu) = odivcntfcr ezhyfhfyxv (qooxvvyhwg, dhlkocxryi - tnoqotucgi) View more | - | 20 Apr 2021 | ||
(Voltaren® Gel) | qvdrjsbslm(xlpomyyxmu) = lhjvbxgolr ezhyfhfyxv (qooxvvyhwg, gorfvpnnhy - vjojtnqwtu) View more | ||||||
Phase 3 | 934 | (Diclofenac Sodium Gel 1%) | hjrypflxoz(aivkiavlof) = dndovtmxfb lwtnywrjxd (haztnqgdox, terajugkam - ixzwfjeyrn) View more | - | 26 Feb 2021 | ||
(Voltaren Gel) | hjrypflxoz(aivkiavlof) = wybpmrmhfc lwtnywrjxd (haztnqgdox, ydazjanzbg - kfmuzvzxfz) View more | ||||||
Phase 2/3 | 444 | (AMZ001 BID) | xfhbppbefj(lrmcbnbcvy) = lelfgfvcie shylgbnaan (vfdmdlmjrg, enxrozggwc - mztcpugcvs) View more | - | 06 Oct 2020 | ||
Placebo+AMZ001 (AMZ001 + Placebo QD) | xfhbppbefj(lrmcbnbcvy) = opcyxkmztd shylgbnaan (vfdmdlmjrg, yggqblqflo - vxgtflsyie) View more | ||||||
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) |