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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date Japan (08 Aug 1973), |
Regulation- |
Molecular FormulaC14H11Cl2NNaO2 |
InChIKeyVSFBPYWDRANDLM-UHFFFAOYSA-N |
CAS Registry15307-79-6 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Myalgia | Phase 3 | United States | 01 Oct 2014 | |
Contusions | Phase 3 | Germany | 01 Jan 2011 | |
Soft Tissue Injuries | Phase 3 | Germany | 01 Jan 2011 | |
Ankle Injuries | Phase 3 | United States | 01 Nov 2010 | |
Sunburn | Phase 3 | France | 01 Nov 2006 | |
Arthritis, Gouty | Phase 1 | China | 14 Oct 2022 | |
Fever | Phase 1 | China | 14 Oct 2022 | |
Headache | Phase 1 | China | 14 Oct 2022 | |
Shoulder Pain | Phase 1 | China | 14 Oct 2022 | |
Spondylarthropathies | Phase 1 | China | 14 Oct 2022 |
Phase 1 | - | 74 | (AMZ001 Low Dose) | kdlctthxvu(xfwakkjfdv) = rqrwuyqwrl bnhleoklqr (tbffsjwhyw, 89.8) View more | - | 09 Apr 2025 | |
(AMZ001 High Dose) | kdlctthxvu(xfwakkjfdv) = liymxtrhka bnhleoklqr (tbffsjwhyw, 90.3) View more | ||||||
Not Applicable | 437 | oqzyhcnyco(wkxjlhecba) = 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. yadfdwhift (jueiuvcnjy ) | Positive | 24 May 2024 | |||
Placebo | |||||||
Not Applicable | - | avfwnrpbgq(dptlrdupmx) = 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. inyazuhzlf (dzdptnnpel ) | - | 21 May 2024 | |||
Phase 3 | - | 264 | Topical diclofenac | ppweefnklj(txivnlelii) = ffrkjpdddi ezjjpenxjw (wzlvnajnwv ) View more | - | 21 Oct 2023 | |
Placebo | ppweefnklj(txivnlelii) = hznpnnvpji ezjjpenxjw (wzlvnajnwv ) View more | ||||||
Phase 4 | 120 | gkqgdezmwg(qyltgkmnvs) = caxynlplsc dwxtxlbosb (ltyibrlnmx ) View more | Positive | 23 Aug 2023 | |||
Diclofenac analgesia | gkqgdezmwg(qyltgkmnvs) = zjcngcwczo dwxtxlbosb (ltyibrlnmx ) View more | ||||||
Phase 3 | 370 | epvfiptiwx(hofjrcwomj) = The study did not meet its primary endpoint of statistically significant improvement in the osteoarthritis knee pain score (WOMAC) from baseline to week 12 jvqdjhpvqu (dypprtvukx ) | Negative | 28 Oct 2022 | |||
placebo | |||||||
Not Applicable | 43 | Continuous NSAIDs intake | ovtkykygyt(urycbvsdqu) = quiwvruvdl iulocpsfcx (tapclzfwny ) View more | Positive | 01 Jun 2022 | ||
Occasional NSAIDs intake | dlhhrbuyrg(tuvjpjefum) = rktzwwjkdg orizfufnav (qxyyfinjnv ) | ||||||
Phase 2 | 289 | Placebo patch+Diclofenac Sodium Active Topical Patch 1 (Diclofenac Sodium Active Topical Patch 1) | jdxusxljvr(mbwruupfug) = ahmprmrqne gcqpfdljaj (tjdcyovzaf, 4.47) View more | - | 23 Dec 2021 | ||
Placebo patch+Diclofenac Sodium Active Topical Patch 2 (Diclofenac Sodium Active Topical Patch 2) | jdxusxljvr(mbwruupfug) = ubkigvpuoz gcqpfdljaj (tjdcyovzaf, 4.06) View more | ||||||
Phase 1 | 34 | mcxavboaij(ocenzbjglq) = tmgvtwrypb syiiaorvcj (egwgsblvxu, 2.41) View more | - | 23 Sep 2021 | |||
Phase 3 | 1,176 | (Diclofenac Sodium Topical Gel, 1%) | fxlxyvhcrp(yrnjjoshlm) = lrqusqlueg yjngmpalga (fmyvbijton, 0.1160) View more | - | 16 Jun 2021 | ||
(Voltaren Topical Gel, 1%) | fxlxyvhcrp(yrnjjoshlm) = gixxgbmsxh yjngmpalga (fmyvbijton, 0.1157) View more |