{"id":"topical-pirfenidone","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Fatigue"},{"rate":"10-20%","effect":"Dyspnea"},{"rate":"5-10%","effect":"Nausea"},{"rate":"5-10%","effect":"Diarrhea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Pirfenidone works by inhibiting the activation of TGF-β, which in turn reduces the production of extracellular matrix proteins and the proliferation of fibroblasts. This leads to a decrease in fibrosis and inflammation. Additionally, pirfenidone has been shown to have antioxidant properties, which may also contribute to its antifibrotic effects.","oneSentence":"Pirfenidone is an antifibrotic agent that inhibits the production of transforming growth factor-beta (TGF-β), a key cytokine involved in fibrosis.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:54:21.020Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Idiopathic pulmonary fibrosis"}]},"trialDetails":[{"nctId":"NCT06871904","phase":"PHASE1, PHASE2","title":"Fibrosis-Modulating Effects of Metformin and Pirfenidone in Oral Submucous Fibrosis","status":"COMPLETED","sponsor":"Ziauddin University","startDate":"2025-04-07","conditions":"Oral Submucous Fibrosis","enrollment":45},{"nctId":"NCT06909812","phase":"PHASE3","title":"Silicone vs Pirfenidone in the Treatment of Hypertrophic Scars and Keloids","status":"COMPLETED","sponsor":"Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.","startDate":"2015-07-14","conditions":"Scars, Keloids, Hypertrophic Scar","enrollment":40},{"nctId":"NCT02823236","phase":"PHASE3","title":"Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars","status":"UNKNOWN","sponsor":"Centro Dermatológico Dr. Ladislao de la Pascua","startDate":"2016-10-24","conditions":"Keloid","enrollment":102},{"nctId":"NCT02222376","phase":"PHASE3","title":"Effect of Topic Pirfenidone in Diabetic Ulcers","status":"COMPLETED","sponsor":"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran","startDate":"2013-10","conditions":"Diabetic Foot Ulcers","enrollment":36}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["KitosCell"],"phase":"phase_3","status":"active","brandName":"Topical Pirfenidone","genericName":"Topical Pirfenidone","companyName":"Centro Dermatológico Dr. Ladislao de la Pascua","companyId":"centro-dermatol-gico-dr-ladislao-de-la-pascua","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Topical Pirfenidone is a small molecule with an unknown mechanism of action, used in various clinical trials for conditions such as scars, keloids, hypertrophic scars, keloid, and diabetic foot ulcers. It has been studied in comparison to silicon gel and other interventions in randomized controlled trials, including a pilot trial for the treatment of hypertrophic scars and keloids.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}