{"id":"amz001-diclofenac-gel","safety":{"commonSideEffects":[{"rate":null,"effect":"Local skin irritation or rash at application site"},{"rate":null,"effect":"Pruritus"},{"rate":null,"effect":"Erythema"}]},"_chembl":{"chemblId":"CHEMBL139","moleculeType":"Small molecule","molecularWeight":"296.15"},"_fixedAt":"2026-03-30T16:26:10.715797","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Diclofenac blocks both COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins that mediate inflammation, pain, and fever. By reducing local prostaglandin levels at the site of application, the topical gel formulation provides localized anti-inflammatory and analgesic effects with reduced systemic exposure compared to oral formulations.","oneSentence":"Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:01:31.568Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Topical treatment of localized pain and inflammation associated with musculoskeletal conditions (e.g., osteoarthritis, sprains, strains)"}]},"_fixedFields":["pubmed(1)"],"trialDetails":[{"nctId":"NCT06693648","phase":"PHASE3","title":"A Study to Evaluate Efficacy and Safety of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms","status":"ACTIVE_NOT_RECRUITING","sponsor":"Amzell","startDate":"2025-02-18","conditions":"Osteoarthritis of Knee, Osteoarthritis, Knee","enrollment":540},{"nctId":"NCT06729073","phase":"PHASE1","title":"Comparison of Diclofenac Systemic Exposure From Two Different Products (AMZ001 and Diclofenac Diethylammonium 1.16% Gel) in Healthy Participants After Repeated Topical Administrations for 7 Days.","status":"COMPLETED","sponsor":"Amzell","startDate":"2024-11-29","conditions":"Healthy Volunteer","enrollment":34},{"nctId":"NCT05968482","phase":"PHASE1","title":"Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants","status":"COMPLETED","sponsor":"Amzell","startDate":"2023-07-11","conditions":"Healthy","enrollment":74},{"nctId":"NCT03691844","phase":"PHASE2, PHASE3","title":"AMZ001 for the Treatment of Knee Osteoarthritis Symptoms","status":"COMPLETED","sponsor":"Amzell","startDate":"2018-10-04","conditions":"Osteoarthritis, Knee","enrollment":444}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"recentPublications":[{"date":"2020 Dec","pmid":"33059293","title":"A novel diclofenac gel (AMZ001) applied once or twice daily in subjects with painful knee osteoarthritis: A randomized, placebo-controlled clinical trial.","journal":"Seminars in arthritis and rheumatism"}],"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":"AMZ001 Diclofenac gel","genericName":"AMZ001 Diclofenac gel","companyName":"Amzell","companyId":"amzell","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain. Used for Topical treatment of localized pain and inflammation associated with musculoskeletal conditions (e.g., osteoarthritis, sprains, strains).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}