{"id":"lodotra","safety":{"commonSideEffects":[{"rate":null,"effect":"Infection"},{"rate":null,"effect":"Hypertension"},{"rate":null,"effect":"Hyperglycemia"},{"rate":null,"effect":"Osteoporosis"},{"rate":null,"effect":"Insomnia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Lodotra uses a delayed-release technology that delivers prednisone at approximately 3 AM, matching the circadian timing of endogenous cortisol production. This chronotherapeutic approach reduces morning inflammation and stiffness in rheumatoid arthritis patients by providing anti-inflammatory corticosteroid activity when disease activity is typically highest. The timing optimization allows for lower total daily doses while improving clinical efficacy and potentially reducing systemic corticosteroid side effects.","oneSentence":"Lodotra is a modified-release formulation of prednisone designed to release the corticosteroid in the early morning hours to align with the body's natural cortisol rhythm and reduce morning stiffness in rheumatoid arthritis.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:52:54.564Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Rheumatoid arthritis (moderate to severe, as monotherapy or adjunctive therapy)"}]},"trialDetails":[{"nctId":"NCT00650078","phase":"PHASE3","title":"Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis","status":"COMPLETED","sponsor":"Amgen","startDate":"2008-03","conditions":"Rheumatoid Arthritis","enrollment":350},{"nctId":"NCT00686335","phase":"PHASE2","title":"A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma","status":"COMPLETED","sponsor":"Amgen","startDate":"2008-06","conditions":"Asthma","enrollment":12},{"nctId":"NCT01821040","phase":"PHASE3","title":"A Study Assessing the Efficacy and Safety of Lodotra® Compared to Prednisone IR in Subjects Suffering From PMR","status":"TERMINATED","sponsor":"Mundipharma Research Limited","startDate":"2013-03","conditions":"Polymyalgia Rheumatica","enrollment":62},{"nctId":"NCT02072200","phase":"PHASE4","title":"Efficacy of Lodotra®(Prednisone) in Reduction of Morning Stiffness Duration(K-IMPROvE)","status":"COMPLETED","sponsor":"Mundipharma Korea Ltd","startDate":"2013-09","conditions":"Rheumatoid Arthritis","enrollment":147}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Modified Release Prednisone","Modified release prednisone","modified release tablet formulation of prednisone"],"phase":"marketed","status":"active","brandName":"Lodotra®","genericName":"Lodotra®","companyName":"Mundipharma Korea Ltd","companyId":"mundipharma-korea-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Lodotra is a modified-release formulation of prednisone designed to release the corticosteroid in the early morning hours to align with the body's natural cortisol rhythm and reduce inflammation in rheumatoid arthritis. Used for Rheumatoid arthritis (moderate to severe, as adjunctive therapy).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}