{"id":"levothyroxine-sodium-new-formulation","safety":{"commonSideEffects":[{"rate":"10%","effect":"Nausea"},{"rate":"5%","effect":"Headache"},{"rate":"5%","effect":"Fatigue"}]},"_chembl":{"chemblId":"CHEMBL2103741","moleculeType":"Small molecule","molecularWeight":"816.87"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Levothyroxine sodium is a synthetic form of the thyroid hormone thyroxine, which plays a crucial role in regulating metabolism, growth, and development. It works by binding to thyroid hormone receptors in the body, stimulating the production of thyroid hormones and regulating their levels.","oneSentence":"Levothyroxine sodium acts on the thyroid hormone receptor.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T02:42:37.466Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypothyroidism"}]},"trialDetails":[{"nctId":"NCT03979274","phase":"PHASE1","title":"A Comparative Study of New Formulation and Approved Formulation for Levothyroxine in Healthy Volunteers","status":"COMPLETED","sponsor":"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","startDate":"2019-12-06","conditions":"Healthy","enrollment":44},{"nctId":"NCT04037748","phase":"PHASE1","title":"Bioequivalence of Two Formulations of Levothyroxine Sodium 200 Micrograms (mcg) Under Tablet Form","status":"COMPLETED","sponsor":"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","startDate":"2019-06-25","conditions":"Healthy","enrollment":72},{"nctId":"NCT01916304","phase":"PHASE2","title":"Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation","status":"COMPLETED","sponsor":"Takeda","startDate":"2013-07","conditions":"Hypothyroidism","enrollment":101}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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_2","status":"active","brandName":"Levothyroxine sodium new formulation","genericName":"Levothyroxine sodium new formulation","companyName":"Takeda","companyId":"takeda","modality":"Small molecule","firstApprovalDate":"","aiSummary":"A new formulation of Levothyroxine sodium is being studied in clinical trials for its efficacy and safety in healthy individuals and those with hypothyroidism. The new formulation is being compared to the approved formulation, Eutirox, in a randomized, single-dose study.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}