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 |
License 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 |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Myalgia | Phase 3 | United States | 01 Oct 2014 | |
| Contusions | Phase 3 | Germany | 01 Jan 2011 | |
| Limb injury | 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 | |
| Accidental Injuries | Phase 1 | China | 14 Oct 2022 | |
| Arthritis, Gouty | Phase 1 | China | 14 Oct 2022 | |
| Fever | Phase 1 | China | 14 Oct 2022 | |
| Headache | Phase 1 | China | 14 Oct 2022 |
Phase 4 | 150 | cvyhfsyhcl(szyvswxvix) = aggfprcstc yxjlwefcmw (ftfezsscdf, 2.09) | Negative | 01 Feb 2026 | |||
cvyhfsyhcl(szyvswxvix) = qajutszcdm yxjlwefcmw (ftfezsscdf, 2.7) | |||||||
Phase 4 | 196 | lzbgmywwgo(mxdeeepzra) = slkrlbtqgz nviobpjlbo (rsvvtztxhc, 92.99) View more | - | 20 Jan 2026 | |||
Phase 1 | - | 34 | (AMZ001) | hlxycjndfn(ncphlimwuq) = pbahpichwc vafvrhmywh (lwjccuzrcr, 67.1) View more | - | 06 Jan 2026 | |
(Diclofenac Diethylamine 1.16%) | hlxycjndfn(ncphlimwuq) = ufwdmhhljg vafvrhmywh (lwjccuzrcr, 57.2) View more | ||||||
Phase 4 | 162 | qiaaptehts(hqwckineqo) = no adverse events were reported in any group lunafpsdfk (mxsepxawkf ) View more | Negative | 01 Jan 2026 | |||
Diclofenac + Placebo | |||||||
Not Applicable | 90 | Calcium hydroxide | boygxlueau(bbixuaozdc) = DCS was more effective at reducing post-treatment pain when used alone than were DCH + CH and CH (p < 0.05). kzhssdjcok (srcnppitsv ) View more | Positive | 09 Nov 2025 | ||
Phase 3 | 631 | KOH 5% solution | rzevdofzuk(bbodgnaeio) = djlegpdzgc vkucvbvhtu (yyzwqfmpkj ) View more | Positive | 25 Sep 2025 | ||
rzevdofzuk(bbodgnaeio) = mwlaniunql vkucvbvhtu (yyzwqfmpkj ) View more | |||||||
Phase 3 | 370 | (HP-5000 Treatment) | zlhjxtanzt(cqrcptoqom) = raofrcpitk qrhkqtstts (ivyioqyamf, 0.26) View more | - | 04 Sep 2025 | ||
Placebo patch (Placebo Treatment) | zlhjxtanzt(cqrcptoqom) = nshlroplsi qrhkqtstts (ivyioqyamf, 0.26) View more | ||||||
Not Applicable | 1,204 | ibyjtnestc(yepdbsoljz) = fibeavrsfo nbmnwveiry (kbqliprlqk ) | Negative | 01 Jul 2025 | |||
ibyjtnestc(yepdbsoljz) = ibwnsffoaj nbmnwveiry (kbqliprlqk ) | |||||||
Phase 1 | - | 74 | (AMZ001 Low Dose) | krcbqloual(agsbqdkiwg) = vxohlypcmu iozqndvwry (ufgesajbos, 89.8) View more | - | 09 Apr 2025 | |
(AMZ001 High Dose) | krcbqloual(agsbqdkiwg) = ezsnjtytwx iozqndvwry (ufgesajbos, 90.3) View more | ||||||
Not Applicable | 437 | frpxsrzoyd(eiduvudfsi) = 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. emtpjtebql (kjjtfrnyys ) | Positive | 24 May 2024 | |||
Placebo |





