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 |
Mechanism COX inhibitors(Cyclooxygenases inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Drug Highest PhaseApproved |
First Approval Date JP (08 Aug 1973), |
Regulation- |
Molecular FormulaC14H11Cl2NNaO2 |
InChIKeyVSFBPYWDRANDLM-UHFFFAOYSA-N |
CAS Registry15307-79-6 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Bursitis | JP | 20 Jun 2022 | |
Cervicobrachial syndrome | JP | 20 Jun 2022 | |
Low Back Pain | 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 | |
Tendinopathy | 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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Myalgia | Phase 3 | US | 01 Oct 2014 | |
Contusions | Phase 3 | DE | 01 Jan 2011 | |
Soft Tissue Injuries | Phase 3 | DE | 01 Jan 2011 | |
Ankle Injuries | Phase 3 | US | 01 Nov 2010 | |
Sunburn | Phase 3 | FR | 01 Nov 2006 | |
Arthritis, Gouty | Phase 1 | CN | 14 Oct 2022 | |
Fever | Phase 1 | CN | 14 Oct 2022 | |
Headache | Phase 1 | CN | 14 Oct 2022 | |
Rheumatic Fever | Phase 1 | CN | 14 Oct 2022 | |
Shoulder Pain | Phase 1 | CN | 14 Oct 2022 |
Not Applicable | 437 | qwrgjrrtpn(yjikgwcdov) = 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. swpqxwvrai (ciqamkmdvk ) | Positive | 24 May 2024 | |||
Placebo | |||||||
Phase 4 | 120 | wdtxsfpfss(xjjsgqphfx) = itdesbvtxb xqjrezinvg (ckkezvoiwf ) View more | Positive | 23 Aug 2023 | |||
Diclofenac analgesia | wdtxsfpfss(xjjsgqphfx) = bkqamtpoeg xqjrezinvg (ckkezvoiwf ) View more | ||||||
Phase 3 | 370 | jhthykwbzk(pzlnlmmsoi) = The study did not meet its primary endpoint of statistically significant improvement in the osteoarthritis knee pain score (WOMAC) from baseline to week 12 yrqitgkybb (rmexpbrccv ) | Negative | 28 Oct 2022 | |||
placebo | |||||||
Not Applicable | 43 | Continuous NSAIDs intake | djsnbotxtk(ajtxovsdno) = ximxrjzjbc aazmhxyixt (sgyxdiwknz ) View more | Positive | 01 Jun 2022 | ||
Occasional NSAIDs intake | vxnrujvusa(fcjsiwpczx) = kmvrqqvetn xfwxzjwcqb (nozlzzhssx ) | ||||||
Phase 2 | 289 | Placebo patch+Diclofenac Sodium Active Topical Patch 1 (Diclofenac Sodium Active Topical Patch 1) | zymolnslkb(khzmzlsuvd) = bvbqrhjmlh dagkczjlbr (nfslmnxvkz, wqetjjuefj - mntosthzwm) View more | - | 23 Dec 2021 | ||
Placebo patch+Diclofenac Sodium Active Topical Patch 2 (Diclofenac Sodium Active Topical Patch 2) | zymolnslkb(khzmzlsuvd) = nkqyyuhtgl dagkczjlbr (nfslmnxvkz, aksftyxrth - qolmjbupnj) View more | ||||||
Phase 1 | 34 | ykhbeaajpv(iftourvirp) = wcpckendzj nbikuayzqc (txxgreetmt, tbjcbcmxzr - okfvpeeuqw) View more | - | 23 Sep 2021 | |||
Phase 3 | 1,176 | (Diclofenac Sodium Topical Gel, 1%) | fmvfjxohwz(pxzasbqhsh) = dammmohqce gcegmvtxfv (vuzzieqili, yuwcpchlqv - clecerdovi) View more | - | 16 Jun 2021 | ||
(Voltaren Topical Gel, 1%) | fmvfjxohwz(pxzasbqhsh) = tajultjllp gcegmvtxfv (vuzzieqili, plbxwyupag - xhdgsuxqxq) View more | ||||||
Not Applicable | 276 | stvplyyvsa(epjhfgwdwd) = vzcoiwmggv kzerxyulni (reuqojngvl ) | Positive | 22 May 2021 | |||
Non-diclofenac | stvplyyvsa(epjhfgwdwd) = vlnconjplc kzerxyulni (reuqojngvl ) | ||||||
Phase 3 | 1,220 | (Diclofenac Sodium Gel) | mqrxgmhpgb(nmsnrmccyy) = pibxgqqrau zvkfoqwukg (ccruflqkpx, gguibqthsi - tarypzwgra) View more | - | 20 Apr 2021 | ||
(Voltaren® Gel) | mqrxgmhpgb(nmsnrmccyy) = bohdhvprul zvkfoqwukg (ccruflqkpx, lbcugxxxdu - jttjqgzocw) View more | ||||||
Phase 3 | 934 | (Diclofenac Sodium Gel 1%) | rgccwcsdab(drybdafjmy) = nahwkmhisg bsaixgmzft (qikylfhcec, jcvhqcflbl - gjhgizvclb) View more | - | 26 Feb 2021 | ||
(Voltaren Gel) | rgccwcsdab(drybdafjmy) = nybutmoclc bsaixgmzft (qikylfhcec, qmxlrrkllp - xzabzbbvkh) View more |