{"id":"krn23","safety":{"commonSideEffects":[{"rate":null,"effect":"Hyperphosphatemia"},{"rate":null,"effect":"Hypercalcemia"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dental abnormalities (in pediatric patients)"}]},"_chembl":{"chemblId":"CHEMBL3707326","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"KRN23 binds to and neutralizes FGF23, a hormone that suppresses renal phosphate reabsorption and 1,25-dihydroxyvitamin D production. By blocking FGF23 activity, the drug allows the kidneys to retain phosphate and increase active vitamin D synthesis, correcting the biochemical abnormalities underlying X-linked hypophosphatemia and improving bone mineralization and growth.","oneSentence":"KRN23 is a monoclonal antibody that inhibits fibroblast growth factor 23 (FGF23), restoring phosphate reabsorption and vitamin D metabolism in patients with X-linked hypophosphatemia.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:51:10.496Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"X-linked hypophosphatemia (XLH) in children and adults"}]},"trialDetails":[{"nctId":"NCT03651505","phase":"","title":"X-linked Hypophosphatemia Disease Monitoring Program","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ultragenyx Pharmaceutical Inc","startDate":"2018-07-16","conditions":"X-linked Hypophosphatemia, Hypophosphatemic Rickets","enrollment":782},{"nctId":"NCT03775187","phase":"","title":"Expanded Access to Burosumab","status":"AVAILABLE","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"","conditions":"X-linked Hypophosphatemia, Tumor-Induced Osteomalacia","enrollment":""},{"nctId":"NCT04188964","phase":"PHASE1, PHASE2","title":"Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Patients Less Than 1 Year of Age","status":"COMPLETED","sponsor":"Kyowa Kirin Pharmaceutical Development Ltd","startDate":"2020-02-26","conditions":"X-linked Hypophosphatemia (XLH)","enrollment":16},{"nctId":"NCT02915705","phase":"PHASE3","title":"Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With XLH","status":"COMPLETED","sponsor":"Kyowa Kirin, Inc.","startDate":"2016-09-08","conditions":"X-Linked Hypophosphatemia","enrollment":61},{"nctId":"NCT05357573","phase":"PHASE4","title":"Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With TIO","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2022-09-07","conditions":"Tumor-Induced Osteomalacia (TIO)","enrollment":9},{"nctId":"NCT04842032","phase":"PHASE4","title":"Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLH","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2021-11-01","conditions":"X-linked Hypophosphatemia (XLH)","enrollment":28},{"nctId":"NCT04842019","phase":"PHASE4","title":"Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With XLH","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2021-09-28","conditions":"X-linked Hypophosphatemia (XLH)","enrollment":18},{"nctId":"NCT02537431","phase":"PHASE3","title":"Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)","status":"COMPLETED","sponsor":"Kyowa Kirin, Inc.","startDate":"2015-12-23","conditions":"X-linked Hypophosphatemia","enrollment":14},{"nctId":"NCT01340482","phase":"PHASE1, PHASE2","title":"A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2011-04","conditions":"X-linked Hypophosphatemia","enrollment":29},{"nctId":"NCT01571596","phase":"PHASE1, PHASE2","title":"An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2012-02","conditions":"X-linked Hypophosphatemia","enrollment":23},{"nctId":"NCT02526160","phase":"PHASE3","title":"Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)","status":"COMPLETED","sponsor":"Kyowa Kirin, Inc.","startDate":"2015-10-22","conditions":"X-linked Hypophosphatemia","enrollment":134},{"nctId":"NCT00830674","phase":"PHASE1","title":"A Study of KRN23 in X-linked Hypophosphatemia","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2008-12","conditions":"X-linked Hypophosphatemia","enrollment":42},{"nctId":"NCT02163577","phase":"PHASE2","title":"Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH)","status":"COMPLETED","sponsor":"Kyowa Kirin, Inc.","startDate":"2014-07-02","conditions":"X-linked Hypophosphatemia","enrollment":52},{"nctId":"NCT02312687","phase":"PHASE2","title":"Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH)","status":"COMPLETED","sponsor":"Kyowa Kirin, Inc.","startDate":"2015-01-30","conditions":"X-Linked Hypophosphatemia","enrollment":20},{"nctId":"NCT02304367","phase":"PHASE2","title":"Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)","status":"COMPLETED","sponsor":"Kyowa Kirin, Inc.","startDate":"2015-03-24","conditions":"Tumor Induced Osteomalacia (TIO), Epidermal Nevus Syndrome (ENS)","enrollment":17},{"nctId":"NCT02750618","phase":"PHASE2","title":"Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)","status":"COMPLETED","sponsor":"Kyowa Kirin, Inc.","startDate":"2016-05-05","conditions":"X-Linked Hypophosphatemia","enrollment":13},{"nctId":"NCT04695860","phase":"PHASE3","title":"Anti-FGF23 (Burosumab) in Adult Patients With XLH","status":"COMPLETED","sponsor":"Wuerzburg University Hospital","startDate":"2021-01-07","conditions":"X-linked Hypophosphatemia","enrollment":36},{"nctId":"NCT04320316","phase":"PHASE4","title":"A Trial to Assess the Safety and Efficacy of KRN23 in Epidermal Nevus Syndrome (ENS)","status":"COMPLETED","sponsor":"University of Alabama at Birmingham","startDate":"2020-07-31","conditions":"Epidermal Nevus Syndrome","enrollment":1},{"nctId":"NCT02722798","phase":"PHASE2","title":"A Study of KRN23 in Subjects With Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2016-04","conditions":"Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome","enrollment":14},{"nctId":"NCT03233126","phase":"PHASE3","title":"A Study of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2017-07-06","conditions":"X-linked Hypophosphatemic Rickets/Osteomalacia","enrollment":16},{"nctId":"NCT04308096","phase":"PHASE3","title":"A Study of KRN23 in Adult and Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2018-01-09","conditions":"XLH","enrollment":27},{"nctId":"NCT03920072","phase":"PHASE3","title":"Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH","status":"COMPLETED","sponsor":"Kyowa Kirin Pharmaceutical Development Ltd","startDate":"2019-03-07","conditions":"X-linked Hypophosphatemia","enrollment":35},{"nctId":"NCT03581591","phase":"PHASE3","title":"Open Label Trial Assessing Safety and Efficacy of Burosumab (KRN23), in a Patient With ENS and Hypophosphatemic Rickets","status":"COMPLETED","sponsor":"Redwood Dermatology Sciences","startDate":"2018-01-31","conditions":"Hypophosphatemia, Hypophosphatemic Rickets, Pain, Chronic","enrollment":1},{"nctId":"NCT02181764","phase":"PHASE1","title":"A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2014-07","conditions":"X-linked Hypophosphatemic Rickets/Osteomalacia","enrollment":15}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":21,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Burosumab","Crysvita","burosumab","Crysvita®"],"phase":"marketed","status":"active","brandName":"KRN23","genericName":"KRN23","companyName":"Kyowa Kirin Co., Ltd.","companyId":"kyowa-kirin-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"KRN23 is a monoclonal antibody that inhibits fibroblast growth factor 23 (FGF23), restoring phosphate reabsorption and vitamin D metabolism in patients with X-linked hypophosphatemia. Used for X-linked hypophosphatemia (XLH) in children and adults.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":5,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}