{"id":"methotrexate-prefilled-pen","safety":{"boxedWarning":"Methotrexate can cause embryo-fetal toxicity, hepatotoxicity, pulmonary toxicity, bone marrow suppression, and serious infections. Should only be used by physicians experienced in antimetabolite therapy. Patients should be closely monitored for toxic effects.","commonSideEffects":["nausea","fatigue","elevated liver enzymes","stomatitis","gastrointestinal upset"],"contraindications":["pregnancy","severe hepatic impairment","severe renal impairment","immunodeficiency syndromes","hypersensitivity to methotrexate"]},"_chembl":null,"modality":"Small molecule","_dailymed":null,"mechanism":{"target":"dihydrofolate reductase (DHFR)","explanation":"Methotrexate competitively inhibits dihydrofolate reductase, preventing the conversion of dihydrofolate to tetrahydrofolate. This depletes cellular folate pools necessary for purine and thymidylate synthesis, ultimately inhibiting DNA replication and cell division, particularly affecting rapidly dividing cells including immune cells.","oneSentence":"Methotrexate inhibits dihydrofolate reductase, blocking folate metabolism and thereby suppressing DNA synthesis and cell proliferation."},"_scrapedAt":"2026-03-28T00:49:58.009Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_claudeStub":{"ts":1779122713,"model":"claude-sonnet-4-5-20250929"},"competitors":[{"name":"adalimumab","brand":"Humira","company":"AbbVie","rationale":"TNF inhibitor used for rheumatoid arthritis and psoriatic arthritis"},{"name":"leflunomide","brand":"Arava","company":"Sanofi","rationale":"Oral DMARD for rheumatoid arthritis and psoriatic arthritis"},{"name":"sulfasalazine","brand":null,"company":null,"rationale":"Conventional DMARD for rheumatoid arthritis"}],"description":"Methotrexate prefilled pen is a convenient delivery system for methotrexate, an antimetabolite and antifolate drug. Developed by medac GmbH, it provides a ready-to-use subcutaneous injection device for patients requiring methotrexate therapy, primarily for autoimmune and inflammatory conditions.","indications":{"approved":[{"status":"approved","condition":"rheumatoid arthritis","patientPopulation":"adult patients with active disease"},{"status":"approved","condition":"psoriasis","patientPopulation":"adult patients with severe disease"},{"status":"approved","condition":"psoriatic arthritis","patientPopulation":"adult patients"}]},"trialDetails":[{"nctId":"NCT07486843","phase":"PHASE4","title":"Preventing Structural Damage in Early Psoriatic Arthritis","status":"RECRUITING","sponsor":"Chinese University of Hong Kong","startDate":"2026-03-16","conditions":"Psoriatic Arthritis (PsA)","enrollment":108},{"nctId":"NCT06239311","phase":"PHASE3","title":"Efficacy and Safety of Methotrexate Versus Placebo in Adults With Atopic Dermatitis.","status":"RECRUITING","sponsor":"medac GmbH","startDate":"2024-02-27","conditions":"Moderate to Severe Atopic Dermatitis","enrollment":277},{"nctId":"NCT02052167","phase":"EARLY_PHASE1","title":"Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients With Juvenile Idiopathic Arthritis","status":"COMPLETED","sponsor":"medac GmbH","startDate":"2014-04","conditions":"Juvenile Idiopathic Arthritis","enrollment":30},{"nctId":"NCT02097173","phase":"PHASE1","title":"Bioavailability in Patient With Psoriasis: Metoject Prefilled Pen","status":"COMPLETED","sponsor":"medac GmbH","startDate":"2013-05","conditions":"Psoriasis","enrollment":35},{"nctId":"NCT01871961","phase":"PHASE1","title":"Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient","status":"COMPLETED","sponsor":"medac GmbH","startDate":"2012-10","conditions":"Rheumatoid Arthritis (RA)","enrollment":105},{"nctId":"NCT01793259","phase":"PHASE3","title":"Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)","status":"COMPLETED","sponsor":"medac GmbH","startDate":"2012-07","conditions":"Rheumatoid Arthritis","enrollment":120}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"methotrexate prefilled pen","genericName":"methotrexate prefilled pen","companyName":"medac GmbH","companyId":"medac-gmbh","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}