{"id":"krystexxa","rwe":[{"pmid":"40698233","year":"2025","title":"Infectious Complications in a Patient Receiving Immunomodulatory Therapy for Gout.","finding":"","journal":"Cureus","studyType":"Clinical Study"},{"pmid":"37991214","year":"2024","title":"A singlicate immunogenicity method to detect anti-polyethylene glycol antibodies: pre- and post-dose of PEGylated therapies.","finding":"","journal":"Bioanalysis","studyType":"Clinical Study"},{"pmid":"34406723","year":"2006","title":"Pegloticase.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"37937020","year":"2023","title":"Gout Treatment and Clinical Considerations: The Role of Pegloticase, Colchicine, and Febuxostat.","finding":"","journal":"Cureus","studyType":"Clinical Study"},{"pmid":"37871112","year":"2023","title":"Comparison table: Some drugs for gout.","finding":"","journal":"The Medical letter on drugs and therapeutics","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Active","category":"status"},{"label":"Selecta Biosciences, Inc.","category":"company"}],"phase":"marketed","safety":{"commonSideEffects":[{"effect":"Gout flare","drugRate":"","severity":"common","organSystem":""},{"effect":"Asthenia","drugRate":"","severity":"common","organSystem":""},{"effect":"Malaise","drugRate":"","severity":"common","organSystem":""},{"effect":"Peripheral swelling","drugRate":"","severity":"common","organSystem":""}],"seriousAdverseEvents":[{"effect":"Anaphylaxis","drugRate":"","severity":"serious"},{"effect":"Infusion Reactions","drugRate":"","severity":"serious"}]},"trials":[],"aliases":["Pegloticase"],"company":"Selecta Biosciences, Inc.","patents":[],"pricing":[],"allNames":["krystexxa®"],"offLabel":[],"synonyms":[],"timeline":[],"approvals":[],"ecosystem":[],"mechanism":{"modality":"Small Molecule","explanation":"Unfortunately, without more information, it's difficult to explain how Krystexxa works in plain English. However, in general, small molecule drugs like Krystexxa are designed to interact with specific proteins or enzymes in the body to produce a therapeutic effect. This can help to either block or enhance the activity of these proteins to treat a range of conditions.","oneSentence":"Krystexxa works by targeting a specific biological pathway to treat a particular condition.","technicalDetail":"As a small molecule drug, Krystexxa is likely to interact with specific receptors or enzymes in the body to produce its therapeutic effect. However, without more information on its target or mechanism of action, it's difficult to provide a detailed technical explanation of how it works."},"commercial":{"revenueYear":2024,"annualRevenue":900,"revenueSource":"Verified: Amgen 10-K","revenueCurrency":"USD","revenueConfidence":"verified"},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=krystexxa%C2%AE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=krystexxa®","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-31T10:28:28.432922","biosimilars":[],"competitors":[],"genericName":"krystexxa®","indications":{"approved":[{"name":"Gout","diseaseId":"gout","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06229145","phase":"PHASE4","title":"A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout","status":"ACTIVE_NOT_RECRUITING","sponsor":"Amgen","startDate":"2024-03-18","conditions":["Gout"],"enrollment":262,"completionDate":"2026-03-12"},{"nctId":"NCT04762498","phase":"PHASE4","title":"A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)","status":"COMPLETED","sponsor":"Amgen","startDate":"2021-01-26","conditions":["Uncontrolled Gout","Chronic Gout"],"enrollment":50,"completionDate":"2023-12-20"},{"nctId":"NCT03635957","phase":"PHASE4","title":"Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout","status":"COMPLETED","sponsor":"Amgen","startDate":"2018-09-26","conditions":["Gout"],"enrollment":14,"completionDate":"2020-10-26"},{"nctId":"NCT03994731","phase":"PHASE4","title":"Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout","status":"COMPLETED","sponsor":"Amgen","startDate":"2019-06-13","conditions":["Gout"],"enrollment":152,"completionDate":"2022-04-11"},{"nctId":"NCT03905512","phase":"PHASE2","title":"A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy","status":"COMPLETED","sponsor":"Selecta Biosciences, Inc.","startDate":"2019-05-07","conditions":["Chronic Gout"],"enrollment":170,"completionDate":"2020-08-05"},{"nctId":"NCT01466166","phase":"","title":"Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout","status":"COMPLETED","sponsor":"Horizon Pharma Rheumatology LLC","startDate":"2011-11-15","conditions":["Refractory Chronic Gout"],"enrollment":188,"completionDate":"2017-06-30"},{"nctId":"NCT01739660","phase":"PHASE1","title":"Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis","status":"COMPLETED","sponsor":"Savient Pharmaceuticals","startDate":"2012-12","conditions":["Chronic Kidney Disease Stage 5"],"enrollment":12,"completionDate":"2013-04"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"formularyStatus":[],"_enricherVersion":"v2-openfda","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"Selecta Biosciences, Inc.","relationship":"Original Developer"}],"publicationCount":15,"therapeuticAreas":["Other"],"_revenueScrapedAt":"2026-04-08 13:58:54.335757+00","biosimilarFilings":[],"originalDeveloper":"Selecta Biosciences, Inc.","recentPublications":[{"date":"2025 Jun","pmid":"40698233","title":"Infectious Complications in a Patient Receiving Immunomodulatory Therapy for Gout.","journal":"Cureus"},{"date":"2024 Jan","pmid":"37991214","title":"A singlicate immunogenicity method to detect anti-polyethylene glycol antibodies: pre- and post-dose of PEGylated therapies.","journal":"Bioanalysis"},{"date":"2006","pmid":"34406723","title":"Pegloticase.","journal":""},{"date":"2023 Oct","pmid":"37937020","title":"Gout Treatment and Clinical Considerations: The Role of Pegloticase, Colchicine, and Febuxostat.","journal":"Cureus"},{"date":"2023 Oct 30","pmid":"37871112","title":"Comparison table: Some drugs for gout.","journal":"The Medical letter on drugs and therapeutics"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","brandName":"KRYSTEXXA®","companyName":"Selecta Biosciences, Inc.","companyId":"selecta-biosciences-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Krystexxa is a small molecule drug developed by Selecta Biosciences, Inc. However, due to the lack of available information, its target, drug class, and approved indications are unknown. The commercial status of Krystexxa is also unclear, as it is not stated whether it is patented or has generic manufacturers. As a result, key safety considerations and its half-life, bioavailability, and off-patent status cannot be determined. Further research is necessary to provide a comprehensive summary of Krystexxa.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":6,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}