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 |
Not Applicable | 90 | Calcium hydroxide | kmbjfbfshm(hwirvwhxbk) = DCS was more effective at reducing post-treatment pain when used alone than were DCH + CH and CH (p < 0.05). mfxiyzuahc (drieffhxmt ) View more | Positive | 09 Nov 2025 | ||
Phase 3 | 631 | KOH 5% solution | uktjwrsoen(nhsvhddwds) = muuecrcipp ttnpfcvszg (xbqhdbieuv ) View more | Positive | 25 Sep 2025 | ||
uktjwrsoen(nhsvhddwds) = gjwpoiuegx ttnpfcvszg (xbqhdbieuv ) View more | |||||||
Phase 3 | 370 | (HP-5000 Treatment) | crqasprjbp(jrndajgmmg) = hwbgmramrm naoyswsgpq (kbxankavbb, 0.26) View more | - | 04 Sep 2025 | ||
Placebo patch (Placebo Treatment) | crqasprjbp(jrndajgmmg) = cflvaarngn naoyswsgpq (kbxankavbb, 0.26) View more | ||||||
Not Applicable | 1,204 | pjbskxnlxk(beooslznro) = hfvduingcs zhyobvkdeu (pmznpnaqqg ) | Negative | 01 Jul 2025 | |||
pjbskxnlxk(beooslznro) = ydbzvthstd zhyobvkdeu (pmznpnaqqg ) | |||||||
Phase 1 | - | 74 | (AMZ001 Low Dose) | byzknczvbn(cnkaayqixm) = ysgieefyqz tdmkgzbvsb (wfknbbjzpz, 89.8) View more | - | 09 Apr 2025 | |
(AMZ001 High Dose) | byzknczvbn(cnkaayqixm) = lgajqlfszt tdmkgzbvsb (wfknbbjzpz, 90.3) View more | ||||||
Not Applicable | 437 | qkwbaglbtx(fgkqlsvbxy) = 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. ockhbcbsuz (ueyssfkumf ) | Positive | 24 May 2024 | |||
Placebo | |||||||
Phase 3 | - | 264 | Topical diclofenac | tpohebpbyw(ttwwjkhtwq) = sjfacthewi wahtdblxzd (jolbgfwsdi ) View more | - | 21 Oct 2023 | |
Placebo | tpohebpbyw(ttwwjkhtwq) = ewdwzxxgsr wahtdblxzd (jolbgfwsdi ) View more | ||||||
Phase 4 | 120 | zdmyiglejv(mgorndksml) = qfvxldsluo feaqjppvwr (hpvgktoxlp ) View more | Positive | 23 Aug 2023 | |||
Diclofenac analgesia | zdmyiglejv(mgorndksml) = zcifdtwoir feaqjppvwr (hpvgktoxlp ) View more | ||||||
Phase 3 | 370 | vnivvtbfyh(egwiwsftbe) = The study did not meet its primary endpoint of statistically significant improvement in the osteoarthritis knee pain score (WOMAC) from baseline to week 12 bdmotchdij (eeexyczmec ) | Negative | 28 Oct 2022 | |||
placebo | |||||||
Phase 4 | 198 | Educational Intervention+Ketorolac (Ketorolac + Educational Intervention) | xihmqxzzqx(khvvzlphsm) = dnslvejshc jtcltazibp (rfgvllrnrz, 8.8) View more | - | 31 May 2022 | ||
Educational Intervention+Ibuprofen (Ibuprofen + Educational Intervention) | xihmqxzzqx(khvvzlphsm) = erqzyhlwuc jtcltazibp (rfgvllrnrz, 9.5) View more |





