{"id":"adagen","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Neutropenia","drugRate":"42.7%","placeboRate":"","totalAtRisk":82,"totalAffected":35,"trialsReporting":4},{"effect":"Cough","drugRate":"40.4%","placeboRate":"","totalAtRisk":57,"totalAffected":23,"trialsReporting":4},{"effect":"Vomiting","drugRate":"33.3%","placeboRate":"","totalAtRisk":57,"totalAffected":19,"trialsReporting":4},{"effect":"Dermatitis diaper","drugRate":"38.0%","placeboRate":"","totalAtRisk":50,"totalAffected":19,"trialsReporting":3},{"effect":"Diarrhoea","drugRate":"31.6%","placeboRate":"","totalAtRisk":57,"totalAffected":18,"trialsReporting":4},{"effect":"Pyrexia","drugRate":"31.6%","placeboRate":"","totalAtRisk":57,"totalAffected":18,"trialsReporting":4},{"effect":"Alanine aminotransferase increased","drugRate":"30.0%","placeboRate":"","totalAtRisk":50,"totalAffected":15,"trialsReporting":3},{"effect":"Aspartate aminotransferase increased","drugRate":"46.7%","placeboRate":"","totalAtRisk":30,"totalAffected":14,"trialsReporting":2},{"effect":"Anemia","drugRate":"65.0%","placeboRate":"","totalAtRisk":20,"totalAffected":13,"trialsReporting":1},{"effect":"Rash","drugRate":"26.0%","placeboRate":"","totalAtRisk":50,"totalAffected":13,"trialsReporting":3},{"effect":"Rhinorrhoea","drugRate":"24.0%","placeboRate":"","totalAtRisk":50,"totalAffected":12,"trialsReporting":3},{"effect":"Leukopenia","drugRate":"36.7%","placeboRate":"","totalAtRisk":30,"totalAffected":11,"trialsReporting":2},{"effect":"Upper respiratory tract infection","drugRate":"19.3%","placeboRate":"","totalAtRisk":57,"totalAffected":11,"trialsReporting":4},{"effect":"Rhinitis","drugRate":"27.5%","placeboRate":"","totalAtRisk":40,"totalAffected":11,"trialsReporting":2},{"effect":"Viral upper respiratory tract infection","drugRate":"36.7%","placeboRate":"","totalAtRisk":30,"totalAffected":11,"trialsReporting":2},{"effect":"Otitis media","drugRate":"20.0%","placeboRate":"","totalAtRisk":50,"totalAffected":10,"trialsReporting":3},{"effect":"Thrombocytopenia","drugRate":"16.0%","placeboRate":"","totalAtRisk":50,"totalAffected":8,"trialsReporting":3},{"effect":"Constipation","drugRate":"14.0%","placeboRate":"","totalAtRisk":57,"totalAffected":8,"trialsReporting":4},{"effect":"Anaemia","drugRate":"80.0%","placeboRate":"","totalAtRisk":10,"totalAffected":8,"trialsReporting":1},{"effect":"Eczema","drugRate":"14.0%","placeboRate":"","totalAtRisk":50,"totalAffected":7,"trialsReporting":3},{"effect":"Nasal congestion","drugRate":"20.0%","placeboRate":"","totalAtRisk":30,"totalAffected":6,"trialsReporting":2},{"effect":"Nausea","drugRate":"8.8%","placeboRate":"","totalAtRisk":57,"totalAffected":5,"trialsReporting":4},{"effect":"Skin lesion","drugRate":"8.8%","placeboRate":"","totalAtRisk":57,"totalAffected":5,"trialsReporting":4},{"effect":"Lymphadenopathy","drugRate":"8.5%","placeboRate":"","totalAtRisk":47,"totalAffected":4,"trialsReporting":3},{"effect":"Rhinovirus infection","drugRate":"20.0%","placeboRate":"","totalAtRisk":20,"totalAffected":4,"trialsReporting":1},{"effect":"Norovirus test positive","drugRate":"20.0%","placeboRate":"","totalAtRisk":20,"totalAffected":4,"trialsReporting":1},{"effect":"Parainfluenzae virus infection","drugRate":"7.5%","placeboRate":"","totalAtRisk":40,"totalAffected":3,"trialsReporting":2},{"effect":"Ear infection","drugRate":"7.5%","placeboRate":"","totalAtRisk":40,"totalAffected":3,"trialsReporting":2},{"effect":"Conjunctivitis","drugRate":"6.0%","placeboRate":"","totalAtRisk":50,"totalAffected":3,"trialsReporting":3},{"effect":"Gastroenteritis viral","drugRate":"6.0%","placeboRate":"","totalAtRisk":50,"totalAffected":3,"trialsReporting":3},{"effect":"Tinea infection","drugRate":"6.0%","placeboRate":"","totalAtRisk":50,"totalAffected":3,"trialsReporting":3},{"effect":"Rash erythematous","drugRate":"15.0%","placeboRate":"","totalAtRisk":20,"totalAffected":3,"trialsReporting":1},{"effect":"Epistaxis","drugRate":"6.4%","placeboRate":"","totalAtRisk":47,"totalAffected":3,"trialsReporting":3},{"effect":"Urinary tract infection","drugRate":"15.0%","placeboRate":"","totalAtRisk":20,"totalAffected":3,"trialsReporting":1},{"effect":"Dry skin","drugRate":"15.0%","placeboRate":"","totalAtRisk":20,"totalAffected":3,"trialsReporting":1},{"effect":"Contusion","drugRate":"15.0%","placeboRate":"","totalAtRisk":20,"totalAffected":3,"trialsReporting":1},{"effect":"Skin abrasion","drugRate":"10.0%","placeboRate":"","totalAtRisk":30,"totalAffected":3,"trialsReporting":2},{"effect":"Gastroenteritis","drugRate":"8.1%","placeboRate":"","totalAtRisk":37,"totalAffected":3,"trialsReporting":3},{"effect":"Human rhinovirus test positive","drugRate":"10.0%","placeboRate":"","totalAtRisk":30,"totalAffected":3,"trialsReporting":2},{"effect":"Influenza","drugRate":"4.3%","placeboRate":"","totalAtRisk":47,"totalAffected":2,"trialsReporting":3},{"effect":"Nasopharyngitis","drugRate":"10.0%","placeboRate":"","totalAtRisk":20,"totalAffected":2,"trialsReporting":1},{"effect":"Transaminases increased","drugRate":"10.0%","placeboRate":"","totalAtRisk":20,"totalAffected":2,"trialsReporting":1},{"effect":"Epstein-Barr virus test positive","drugRate":"5.0%","placeboRate":"","totalAtRisk":40,"totalAffected":2,"trialsReporting":2},{"effect":"Erythema","drugRate":"5.4%","placeboRate":"","totalAtRisk":37,"totalAffected":2,"trialsReporting":3},{"effect":"Seborrhoeic dermatitis","drugRate":"6.7%","placeboRate":"","totalAtRisk":30,"totalAffected":2,"trialsReporting":2},{"effect":"Fall","drugRate":"5.4%","placeboRate":"","totalAtRisk":37,"totalAffected":2,"trialsReporting":3},{"effect":"Lower respiratory tract infection","drugRate":"10.0%","placeboRate":"","totalAtRisk":20,"totalAffected":2,"trialsReporting":1},{"effect":"Metapneumovirus infection","drugRate":"10.0%","placeboRate":"","totalAtRisk":20,"totalAffected":2,"trialsReporting":1},{"effect":"Viral rash","drugRate":"10.0%","placeboRate":"","totalAtRisk":20,"totalAffected":2,"trialsReporting":1},{"effect":"Device related infection","drugRate":"10.0%","placeboRate":"","totalAtRisk":20,"totalAffected":2,"trialsReporting":1}],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"trials":[],"_chembl":{"chemblId":"CHEMBL1201514","moleculeType":"Enzyme"},"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"_dailymed":null,"ecosystem":[],"mechanism":{},"_scrapedAt":"2026-03-28T00:59:30.370Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"references":[],"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T08:44:48.717797+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[{"name":"Adenosine deaminase deficiency","diseaseId":"adenosine-deaminase-deficiency","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03878069","phase":"","title":"Registry Study of Revcovi Treatment in Patients With ADA-SCID","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2019-09-30","conditions":"Adenosine Deaminase Severe Combined Immunodeficiency","enrollment":32},{"nctId":"NCT03765632","phase":"PHASE1, PHASE2","title":"Efficacy and Safety of the Cryopreserved Formulation of OTL-101 in Subjects With ADA-SCID","status":"COMPLETED","sponsor":"Great Ormond Street Hospital for Children NHS Foundation Trust","startDate":"2018-01-03","conditions":"Severe Combined Immunodeficiency Due to ADA Deficiency","enrollment":13},{"nctId":"NCT01852071","phase":"PHASE1, PHASE2","title":"Autologous CD34+ Hematopoietic Stem Cells Transduced ex Vivo With Elongation Factor 1 Alpha Shortened (EFS) Lentiviral Vector Encoding for the Human ADA Gene","status":"COMPLETED","sponsor":"University of California, Los Angeles","startDate":"2013-08-02","conditions":"ADA-SCID","enrollment":46},{"nctId":"NCT02999984","phase":"PHASE1, PHASE2","title":"Efficacy and Safety of the Cryopreserved Formulation of OTL-101 in Subjects With ADA-SCID","status":"COMPLETED","sponsor":"University of California, Los Angeles","startDate":"2016-12-16","conditions":"Severe Combined Immunodeficiency Due to ADA Deficiency","enrollment":10},{"nctId":"NCT01380990","phase":"PHASE1, PHASE2","title":"Lentiviral (LV) Gene Therapy for Adenosine Deaminase (ADA) Deficiency","status":"COMPLETED","sponsor":"Great Ormond Street Hospital for Children NHS Foundation Trust","startDate":"2012-11-15","conditions":"Adenosine Deaminase Deficiency, Severe Combined Immunodeficiencies (SCID)","enrollment":36},{"nctId":"NCT00794508","phase":"PHASE2","title":"MND-ADA Transduction of CD34+ Cells From Children With ADA-SCID","status":"COMPLETED","sponsor":"Donald B. Kohn, M.D.","startDate":"2008-11","conditions":"Severe Combined Immunodeficiency","enrollment":10},{"nctId":"NCT01346150","phase":"","title":"Patients Treated for SCID (1968-Present)","status":"UNKNOWN","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2011-05-15","conditions":"SCID, ADA-SCID, XSCID","enrollment":1007},{"nctId":"NCT01186913","phase":"","title":"Natural History Study of SCID Disorders","status":"ENROLLING_BY_INVITATION","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2010-09-02","conditions":"Severe Combined Immunodeficiency (SCID), Leaky SCID, Omenn Syndrome","enrollment":690},{"nctId":"NCT01420627","phase":"PHASE3","title":"EZN-2279 in Patients With ADA-SCID","status":"COMPLETED","sponsor":"Leadiant Biosciences, Inc.","startDate":"2014-01-24","conditions":"ADA-SCID, Adenosine Deaminase Deficiency, Severe Combined Immunodeficiency","enrollment":7},{"nctId":"NCT00001255","phase":"","title":"Gene Transfer Therapy for Severe Combined Immunodeficieny Disease (SCID) Due to Adenosine Deaminase (ADA) Deficiency: A Natural History Study","status":"COMPLETED","sponsor":"National Human Genome Research Institute (NHGRI)","startDate":"1990-09","conditions":"Severe Combined Immunodeficiency","enrollment":10}],"_emaApprovals":[],"_faersSignals":[{"count":8,"reaction":"INFECTION"},{"count":7,"reaction":"DERMATOFIBROSARCOMA PROTUBERANS"},{"count":7,"reaction":"HAEMOLYTIC ANAEMIA"},{"count":7,"reaction":"RESPIRATORY FAILURE"},{"count":6,"reaction":"DEATH"},{"count":6,"reaction":"HEPATIC ENZYME INCREASED"},{"count":5,"reaction":"DIARRHOEA"},{"count":5,"reaction":"PNEUMONIA"},{"count":5,"reaction":"RESPIRATORY TRACT INFECTION"},{"count":4,"reaction":"B-CELL LYMPHOMA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":13,"therapeuticAreas":["Other"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"phase_3","status":"active","brandName":"Adagen","genericName":"Adagen","companyName":"Leadiant Biosciences, Inc.","companyId":"leadiant-biosciences-inc","modality":"Biologic","firstApprovalDate":"","aiSummary":"Adagen, also known as elapegademase-lvlr, is a hydrolytic enzyme that targets 2'-deoxyadenosine. It is used to treat severe combined immunodeficiency (SCID), including ADA-SCID, XSCID, Leaky SCID, and Omenn Syndrome.","enrichmentLevel":5,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1990-03-21T00:00:00.000Z","mah":"LEADIANT BIOSCI INC","brand_name_local":"ADAGEN","application_number":"BLA019818"}],"trialStats":{"total":6,"withResults":5},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T08:44:48.717797+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}