{"id":"cd5789-trifarotene","safety":{"commonSideEffects":[{"rate":null,"effect":"Skin irritation"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nasopharyngitis"}]},"_chembl":{"chemblId":"CHEMBL3707313","moleculeType":"Small molecule","molecularWeight":"459.59"},"_fixedAt":"2026-03-30T13:35:44.905646","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Trifarotene selectively activates retinoid X receptors (RXR), which are nuclear receptors involved in regulating inflammatory pathways and keratinocyte differentiation. By binding to RXR, the drug modulates transcription of genes involved in skin inflammation and barrier function, making it effective for inflammatory skin conditions. This selective RXR mechanism differs from traditional retinoids by offering potentially improved tolerability with reduced off-target effects.","oneSentence":"Trifarotene is a selective retinoid X receptor (RXR) agonist that modulates gene expression to reduce inflammation and promote skin cell differentiation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:05:02.629Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Psoriasis"},{"name":"Atopic dermatitis"}]},"_fixedFields":["pubmed(79)"],"trialDetails":[{"nctId":"NCT07186413","phase":"PHASE3","title":"A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris","status":"RECRUITING","sponsor":"Galderma R&D","startDate":"2025-09-23","conditions":"Acne Vulgaris","enrollment":561},{"nctId":"NCT04856904","phase":"PHASE4","title":"Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2021-05-28","conditions":"Acne Vulgaris","enrollment":121},{"nctId":"NCT05089708","phase":"PHASE4","title":"AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2021-12-22","conditions":"Acne Vulgaris","enrollment":123},{"nctId":"NCT03738800","phase":"PHASE2","title":"A Safety, Efficacy and Systemic Exposure Study of CD5789 Cream in Adults and Adolescents With Lamellar Ichthyosis","status":"TERMINATED","sponsor":"Mayne Pharma International Pty Ltd","startDate":"2019-05-01","conditions":"Lamellar Ichthyosis","enrollment":65},{"nctId":"NCT04451330","phase":"PHASE4","title":"A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2020-07-29","conditions":"Acne Vulgaris","enrollment":202},{"nctId":"NCT01616654","phase":"PHASE2","title":"Dose Range Study of CD5789 in Acne Vulgaris","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2012-06-20","conditions":"Acne Vulgaris","enrollment":304},{"nctId":"NCT02189629","phase":"PHASE3","title":"CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2015-02-23","conditions":"Acne Vulgaris","enrollment":453},{"nctId":"NCT02556788","phase":"PHASE3","title":"Double-Blind Efficacy and Safety of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream in Acne Vulgaris","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2015-11","conditions":"Acne Vulgaris","enrollment":1212},{"nctId":"NCT02566369","phase":"PHASE3","title":"Efficacy and Safety of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream in Acne Vulgaris","status":"COMPLETED","sponsor":"Galderma R&D","startDate":"2015-11-30","conditions":"Acne Vulgaris","enrollment":1208},{"nctId":"NCT01804335","phase":"PHASE1","title":"CD5789 in Early Cutaneous T-Cell Lymphoma (CTCL)","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","startDate":"2013-02","conditions":"Lymphoma","enrollment":11}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":79,"recentPublications":[{"date":"2026 Mar 18","pmid":"41847993","title":"Update of the EuroGuiDerm evidence-based guideline for the treatment of acne-Short version.","journal":"Journal of the European Academy of Dermatology and Venereology : JEADV"},{"date":"2026 Feb 13","pmid":"41692081","title":"Vitamins and the skin: Vitamin A and retinoids in dermatology.","journal":"Clinics in dermatology"},{"date":"2026 Jan 11","pmid":"41599725","title":"Divergent System Organ Class Safety Profiles of Isotretinoin Versus Topical Retinoids: An EudraVigilance Disproportionality Analysis.","journal":"Pharmaceuticals (Basel, Switzerland)"},{"date":"2026 Jan","pmid":"41457483","title":"Bridging Gaps in Malaysian Acne Vulgaris Guidelines: Advisory Statements on Trifarotene for Facial and Truncal Acne.","journal":"Journal of cosmetic dermatology"},{"date":"2026 Mar","pmid":"41286546","title":"Patient Insights on Acne Hyperpigmentation, Trifarotene, and Skincare: 6-Month, LEAP Phase 4 Qualitative Exit Interview Findings.","journal":"The patient"}],"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":"CD5789 (trifarotene)","genericName":"CD5789 (trifarotene)","companyName":"Galderma R&D","companyId":"galderma-r-d","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Trifarotene, also known as CD5789, is a small molecule that acts as a retinoic acid receptor gamma agonist. It is being studied as a treatment for Acne Vulgaris, specifically in a clinical trial comparing its efficacy and safety when used with an oral antibiotic.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}