{"id":"acitretin-capsules","safety":{"commonSideEffects":[{"rate":"50-80","effect":"Dry skin and mucous membranes"},{"rate":"40-60","effect":"Cheilitis"},{"rate":"30-50","effect":"Pruritus"},{"rate":"10-25","effect":"Alopecia"},{"rate":"10-20","effect":"Nail dystrophy"},{"rate":"10-15","effect":"Headache"},{"rate":"20-40","effect":"Elevated triglycerides"},{"rate":"10-20","effect":"Elevated liver enzymes"},{"rate":null,"effect":"Teratogenicity (if exposed during pregnancy)"}]},"_chembl":{"chemblId":"CHEMBL1131","moleculeType":"Small molecule","molecularWeight":"326.44"},"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$6.0064/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$2,192","description":"ACITRETIN 10 MG CAPSULE","retrievedDate":"2026-04-07"}],"timeline":[{"date":"1984","type":"Approval","milestone":"First approval in Europe","regulator":"EMA"},{"date":"2023","type":"Manufacturing","milestone":"Manufacturing by Army Medical University, China","regulator":"NMPA"}],"_dailymed":null,"aiSummary":"Acitretin is a retinoid used primarily for the treatment of severe psoriasis. It is not approved by the FDA and is manufactured by the Army Medical University in China. The drug works by regulating the growth and differentiation of skin cells. Common side effects include dry skin, mucous membrane irritation, and elevated liver enzymes. Due to its teratogenicity, it is contraindicated in pregnant women. Acitretin is not commercially available in the US, but it has a significant presence in other markets.","mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Acitretin is a second-generation retinoid that acts as a ligand for retinoid X receptors (RXR) and retinoid acid receptors (RAR), modulating gene transcription involved in cell differentiation and proliferation. By normalizing epithelial cell turnover and reducing hyperkeratinization, it is effective in treating disorders characterized by abnormal skin cell growth and differentiation. The drug's effects on epithelial cells make it particularly useful in psoriasis and other keratinization disorders.","oneSentence":"Acitretin is a retinoid that binds to retinoid receptors to regulate the growth, differentiation, and keratinization of epithelial cells.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:24:53.123Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"N/A","launchDate":"N/A","annualCostUS":"N/A","currentRevenue":"N/A","patientPopulation":"Severe psoriasis patients","peakSalesEstimate":"N/A"},"competitors":["Isotretinoin","Methotrexate","Biologics (e.g., adalimumab, ustekinumab)"],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[{"name":"Severe psoriasis"},{"name":"Lichen planus"},{"name":"Pityriasis rubra pilaris"},{"name":"Ichthyosis and keratinization disorders"}]},"trialDetails":[{"nctId":"NCT06998875","phase":"PHASE4","title":"A Prospective Cohort Study on Primary Cutaneous Amyloidosis","status":"RECRUITING","sponsor":"Army Medical University, China","startDate":"2025-03-01","conditions":"Primary Cutaneous Amyloidosis","enrollment":56},{"nctId":"NCT04537689","phase":"PHASE4","title":"Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis","status":"RECRUITING","sponsor":"Singapore General Hospital","startDate":"2020-12-10","conditions":"Plaque Psoriasis","enrollment":40},{"nctId":"NCT04239859","phase":"PHASE4","title":"Outcomes With Treatment and Withdraw of Secukinumab in Patients With Plaque Psoriasis","status":"NOT_YET_RECRUITING","sponsor":"Singapore General Hospital","startDate":"2024-01","conditions":"Plaque Psoriasis","enrollment":40},{"nctId":"NCT05401006","phase":"PHASE4","title":"Effect of Acitretin Versus Narrowband Ultraviolet B on Neopterin Level in Psoriatic Patients .","status":"UNKNOWN","sponsor":"South Valley University","startDate":"2021-06-05","conditions":"Psoriasis","enrollment":30},{"nctId":"NCT04245319","phase":"NA","title":"Combined Effect of Acitretin and Narrow Band Ultraviolet B on Vitiligo Repigmentation","status":"UNKNOWN","sponsor":"Cairo University","startDate":"2020-01-01","conditions":"Hyperlipidemias, Xerosis, Depression","enrollment":20},{"nctId":"NCT01094717","phase":"NA","title":"Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis","status":"TERMINATED","sponsor":"University of Utah","startDate":"2010-01","conditions":"Psoriasis","enrollment":13},{"nctId":"NCT02715960","phase":"PHASE2","title":"Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Acitretin Capsules","status":"UNKNOWN","sponsor":"Central South University","startDate":"2015-12","conditions":"Psoriasis Vulgaris","enrollment":500},{"nctId":"NCT00832364","phase":"PHASE4","title":"Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis","status":"WITHDRAWN","sponsor":"Stiefel, a GSK Company","startDate":"2009-10","conditions":"Plaque Psoriasis","enrollment":""},{"nctId":"NCT01233583","phase":"","title":"Regulatory T-cells in Psoriasis Patients as Targets for Therapy","status":"COMPLETED","sponsor":"University of Aberdeen","startDate":"2010-06","conditions":"Psoriasis","enrollment":38},{"nctId":"NCT01545284","phase":"PHASE2, PHASE3","title":"Pilot Study on the Use of Acitretin for the Treatment of Severe Chronic Hand Dermatitis","status":"COMPLETED","sponsor":"Innovaderm Research Inc.","startDate":"2012-03","conditions":"Chronic Hand Dermatitis","enrollment":9},{"nctId":"NCT02191020","phase":"NA","title":"Efficacy and Safety Study of Total Glucosides of Paeony Combined With Acitretin to Treat Psoriasis","status":"COMPLETED","sponsor":"Xijing Hospital","startDate":"2013-02","conditions":"Psoriasis","enrollment":108},{"nctId":"NCT01443338","phase":"PHASE4","title":"Study Evaluating the Efficacy and Safety of Triptergium Wilfordii and Acitretin in Psoriasis Vulgaris - CHINA201002016-2","status":"UNKNOWN","sponsor":"Ministry of Health, China","startDate":"2011-09","conditions":"Psoriasis Vulgaris","enrollment":720},{"nctId":"NCT01039142","phase":"PHASE4","title":"Dose Ranging Study to Assess the Efficacy and Safety of Acitretin in Severe Plaque Type Psoriasis","status":"COMPLETED","sponsor":"Post Graduate Institute of Medical Education and Research, Chandigarh","startDate":"2008-03","conditions":"Psoriasis","enrollment":61}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":18,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Acitretin Capsules.","genericName":"Acitretin Capsules.","companyName":"Army Medical University, China","companyId":"army-medical-university-china","modality":"Small molecule","firstApprovalDate":"N/A","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}