{"id":"diclofenac-diethylamine-2-32-gel","safety":{"commonSideEffects":[{"rate":null,"effect":"Local skin irritation or erythema"},{"rate":null,"effect":"Contact dermatitis"},{"rate":null,"effect":"Photosensitivity"}]},"_chembl":{"chemblId":"CHEMBL139","moleculeType":"Small molecule","molecularWeight":"296.15"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Diclofenac works by blocking COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins that mediate inflammation, pain, and fever. The diethylamine salt formulation enhances skin penetration when applied topically as a gel, allowing the active drug to reach affected tissues. This localized delivery minimizes systemic exposure compared to oral NSAIDs.","oneSentence":"Diclofenac diethylamine is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain at the site of application.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:45:48.408Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Topical treatment of localized pain and inflammation associated with musculoskeletal conditions (e.g., sprains, strains, osteoarthritis)"}]},"trialDetails":[{"nctId":"NCT05026320","phase":"PHASE2","title":"A Clinical Trial to Compare Safety and Effectiveness for Relieving Tenderness of 10% Naproxen Gel vs. a 2.32% Diclofenac Diethylamine Gel in the Treatment of Strains and Bruises of the Legs.","status":"COMPLETED","sponsor":"Bayer","startDate":"2021-08-08","conditions":"Soft Tissue Injury","enrollment":76},{"nctId":"NCT04052620","phase":"PHASE3","title":"Voltaren Emulgel 2% Acute Ankle Sprain Non Inferiority Study","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2019-10-24","conditions":"Pain","enrollment":313},{"nctId":"NCT03497039","phase":"PHASE1","title":"A Study to Characterize Diclofenac's Plasma and Knee Exposure After Application of Diclofenac Gel to the Knee of Subjects With Osteoarthritis That Have a Scheduled Arthroplasty","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2018-07-19","conditions":"Pain","enrollment":47},{"nctId":"NCT01967550","phase":"PHASE3","title":"Efficacy and Safety of Diclofenac DDEA 2.32 % in Patient Suffering From Knee Osteoarthritis (OA)","status":"COMPLETED","sponsor":"Novartis","startDate":"2013-10","conditions":"Osteoarthritis, Knee","enrollment":304},{"nctId":"NCT00955513","phase":"PHASE3","title":"Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain","status":"COMPLETED","sponsor":"Novartis","startDate":"2009-07","conditions":"Grade I/II Ankle Sprain","enrollment":242},{"nctId":"NCT00573768","phase":"PHASE2","title":"Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain","status":"COMPLETED","sponsor":"Novartis","startDate":"2007-11","conditions":"Ankle Sprain","enrollment":271}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Diclofenac diethylamine 2.32% gel","genericName":"Diclofenac diethylamine 2.32% gel","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Diclofenac diethylamine is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain at the site of application. Used for Topical treatment of localized pain and inflammation associated with musculoskeletal conditions (e.g., sprains, strains, osteoarthritis).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}