{"id":"crisantaspase","rwe":[{"pmid":"41294642","year":"2025","title":"Asparaginase Hypersensitivity Reactions in NK/T-Cell Lymphomas.","finding":"","journal":"Clinics and practice","studyType":"Clinical Study"},{"pmid":"40367403","year":"2025","title":"User-Centered Design and Comparison of Two Electronic Health Record Tools to Support the Ordering of Crisantaspase Recombinant Chemotherapy.","finding":"","journal":"JCO clinical cancer informatics","studyType":"Clinical Study"},{"pmid":"39437546","year":"2025","title":"A phase 1 study of the amino acid modulator pegcrisantaspase and venetoclax for relapsed or refractory acute myeloid leukemia.","finding":"","journal":"Blood","studyType":"Clinical Study"},{"pmid":"38951899","year":"2024","title":"Long-acting Erwinia chrysanthemi, Pegcrisantaspase, induces alternate amino acid biosynthetic pathways in a preclinical model of pancreatic ductal adenocarcinoma.","finding":"","journal":"Cancer & metabolism","studyType":"Clinical Study"},{"pmid":"38690164","year":"2024","title":"Dual targeting of glutamine and serine metabolism in acute myeloid leukemia.","finding":"","journal":"Frontiers in oncology","studyType":"Clinical Study"}],"tags":[{"label":"Biologic","category":"modality"},{"label":"Intramuscular","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Acute lymphoid leukemia","category":"indication"},{"label":"Jazz Pharms Inc","category":"company"},{"label":"Approved 2010s","category":"decade"},{"label":"Antineoplastic Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":549.843,"date":"","count":368,"signal":"Febrile neutropenia","source":"DrugCentral FAERS","actionTaken":"Reported 368 times (LLR=550)"},{"llr":526.942,"date":"","count":115,"signal":"Mycobacterium chelonae infection","source":"DrugCentral FAERS","actionTaken":"Reported 115 times (LLR=527)"},{"llr":491.829,"date":"","count":113,"signal":"Secondary immunodeficiency","source":"DrugCentral FAERS","actionTaken":"Reported 113 times (LLR=492)"},{"llr":461.064,"date":"","count":140,"signal":"Venoocclusive liver disease","source":"DrugCentral FAERS","actionTaken":"Reported 140 times (LLR=461)"},{"llr":364.573,"date":"","count":151,"signal":"Bacterial infection","source":"DrugCentral FAERS","actionTaken":"Reported 151 times (LLR=365)"},{"llr":320.612,"date":"","count":65,"signal":"Human bocavirus infection","source":"DrugCentral FAERS","actionTaken":"Reported 65 times (LLR=321)"},{"llr":319.982,"date":"","count":124,"signal":"Posterior reversible encephalopathy syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 124 times (LLR=320)"},{"llr":313.264,"date":"","count":133,"signal":"Clostridium difficile colitis","source":"DrugCentral FAERS","actionTaken":"Reported 133 times (LLR=313)"},{"llr":302.684,"date":"","count":87,"signal":"Pseudomonal sepsis","source":"DrugCentral FAERS","actionTaken":"Reported 87 times (LLR=303)"},{"llr":295.208,"date":"","count":83,"signal":"Human herpesvirus 6 infection","source":"DrugCentral FAERS","actionTaken":"Reported 83 times (LLR=295)"},{"llr":290.919,"date":"","count":82,"signal":"Parainfluenzae virus infection","source":"DrugCentral FAERS","actionTaken":"Reported 82 times (LLR=291)"},{"llr":254.868,"date":"","count":75,"signal":"Pneumatosis intestinalis","source":"DrugCentral FAERS","actionTaken":"Reported 75 times (LLR=255)"},{"llr":237.26,"date":"","count":98,"signal":"Bronchopulmonary aspergillosis","source":"DrugCentral FAERS","actionTaken":"Reported 98 times (LLR=237)"},{"llr":232.759,"date":"","count":50,"signal":"Abscess bacterial","source":"DrugCentral FAERS","actionTaken":"Reported 50 times (LLR=233)"},{"llr":225.228,"date":"","count":73,"signal":"Rhinovirus infection","source":"DrugCentral FAERS","actionTaken":"Reported 73 times (LLR=225)"}],"commonSideEffects":[]},"trials":[],"aliases":[],"company":"Jazz Pharms Inc","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CRISANTASPASE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:03:06.705682+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Crisantaspase","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:03:16.471159+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:03:15.008743+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Asparagine hydrolytic enzyme","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:03:16.471103+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2108931/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:03:16.135181+00:00"}},"allNames":"erwinase","offLabel":[],"synonyms":["crisantaspase","erwinase","erwinaze","asparaginase Erwinia chrysanthemi"],"timeline":[{"date":"2011-11-18","type":"positive","source":"DrugCentral","milestone":"FDA approval (Jazz Pharms Inc)"}],"approvals":[{"date":"2011-11-18","orphan":true,"company":"JAZZ PHARMS INC","regulator":"FDA"}],"brandName":"Erwinase","ecosystem":[{"indication":"Acute lymphoid leukemia","otherDrugs":[{"name":"asparaginase","slug":"asparaginase","company":"Merck"},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""},{"name":"clofarabine","slug":"clofarabine","company":"Genzyme"}],"globalPrevalence":null}],"mechanism":{"modality":"Biologic","explanation":"","oneSentence":"","technicalDetail":"Erwinase is a small molecule that specifically targets and degrades the enzyme L-asparaginase, which is essential for the growth and survival of leukemia cells. By breaking down this enzyme, Erwinase creates a deficiency in asparagine, a critical amino acid for leukemia cells, leading to their death."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Asparaginase","title":"Asparaginase","extract":"Asparaginase is an enzyme that is used as a medication and in food manufacturing. As a medication, L-asparaginase is used to treat acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). It is given by injection into a vein, or muscle. A PEGylated version, pegaspargase, is also available. In food manufacturing it is used to decrease acrylamide.","wiki_history":"==History==\nThe discovery and development of asparaginase as an anti-cancer drug began in 1953, when scientists first observed that lymphomas in rat and mice regressed after treatment with guinea pig serum. Later it was found out that it is not the serum itself which provoke the tumour regression, but rather the enzyme asparaginase.\n\nAfter researchers comparing different kinds of asparaginases, the one derived from Escherichia coli and Erwinia chrysanthemi turned out to have the best anti-cancer ability. E. coli has thereby become the main source of asparaginase due to the factor that it is also easy to produce in large amounts."},"commercial":{"launchDate":"2011","_launchSource":"DrugCentral (FDA 2011-11-18, JAZZ PHARMS INC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5216","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CRISANTASPASE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CRISANTASPASE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Asparaginase","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T10:19:18.619125","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:03:17.696949+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"crisantaspase","indications":{"approved":[{"name":"Acute lymphoid leukemia","source":"DrugCentral","snomedId":91857003,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06317662","phase":"PHASE2","title":"Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2025-06-05","conditions":["Acute Leukemia of Ambiguous Lineage","B Acute Lymphoblastic Leukemia"],"enrollment":153,"completionDate":"2028-12-31"},{"nctId":"NCT03914625","phase":"PHASE3","title":"A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2019-07-03","conditions":["B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma","Down Syndrome"],"enrollment":6720,"completionDate":"2027-09-30"},{"nctId":"NCT05748171","phase":"PHASE2","title":"A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL","status":"RECRUITING","sponsor":"Pfizer","startDate":"2023-05-17","conditions":["ACUTE LYMPHOBLASTIC LEUKEMIA"],"enrollment":100,"completionDate":"2036-11-04"},{"nctId":"NCT06918431","phase":"PHASE2","title":"Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma","status":"RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2025-10-10","conditions":["B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative","Lymphoblastic Lymphoma"],"enrollment":53,"completionDate":"2029-03-30"},{"nctId":"NCT06738368","phase":"PHASE2","title":"Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia","status":"RECRUITING","sponsor":"University of Washington","startDate":"2026-04-01","conditions":["B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative","T Acute Lymphoblastic Leukemia"],"enrollment":30,"completionDate":"2028-07-30"},{"nctId":"NCT07133997","phase":"PHASE1","title":"Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukemia","status":"NOT_YET_RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2026-06-01","conditions":["Recurrent B Acute Lymphoblastic Leukemia","Refractory B Acute Lymphoblastic Leukemia"],"enrollment":26,"completionDate":"2027-05-08"},{"nctId":"NCT05292664","phase":"PHASE1","title":"Venetoclax Basket Trial for High Risk Hematologic Malignancies","status":"RECRUITING","sponsor":"Andrew E. 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Recombinant Erwinia Asparaginase for Treatment of ALL / LBL Patients With Hypersensitivity to E. 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