{"id":"fty720","rwe":[],"tags":[],"safety":{"safetySignals":[{"date":"","signal":"BLOOD CREATININE INCREASED","source":"FDA FAERS","actionTaken":"Reported 15 times"},{"date":"","signal":"HYPOTENSION","source":"FDA FAERS","actionTaken":"Reported 6 times"},{"date":"","signal":"KIDNEY TRANSPLANT REJECTION","source":"FDA FAERS","actionTaken":"Reported 6 times"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"Reported 6 times"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"Reported 5 times"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"Reported 5 times"},{"date":"","signal":"DISEASE PROGRESSION","source":"FDA FAERS","actionTaken":"Reported 4 times"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"Reported 4 times"},{"date":"","signal":"GRAFT DYSFUNCTION","source":"FDA FAERS","actionTaken":"Reported 4 times"},{"date":"","signal":"NEPHROPATHY TOXIC","source":"FDA FAERS","actionTaken":"Reported 4 times"}],"drugInteractions":[{"drug":"CYP450 inhibitors","action":"Monitor","effect":"Increased FTY720 plasma concentrations"},{"drug":"CYP450 inducers","action":"Monitor","effect":"Decreased FTY720 plasma concentrations"},{"drug":"Live vaccines","action":"Avoid","effect":"Increased risk of infection"},{"drug":"Anticoagulants","action":"Monitor","effect":"Increased bleeding risk"},{"drug":"Immunosuppressants","action":"Monitor","effect":"Additive immunosuppressive effects"}],"commonSideEffects":[],"contraindications":["Recent myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure with hospitalization, or Class III/IV heart failure.","History of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome, unless patient has a pacemaker.","Baseline QTc interval ≥ 500 msec.","Cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs.","Hypersensitivity to fingolimod or its excipients."],"specialPopulations":{"Pregnancy":"","Geriatric use":"","Paediatric use":"","Renal impairment":"","Hepatic impairment":""}},"trials":[],"_chembl":null,"aliases":["0.5 mg gelatin capsules"],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=FTY720","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:33:49.922585+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Fty720","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:33:58.506594+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:33:56.689036+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T03:33:49.946972+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FTY720","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:33:57.734127+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL366208/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:33:58.398304+00:00"}},"offLabel":[],"timeline":[{"date":"1992-01-01","type":"positive","milestone":"First synthesized by Yoshitomi Pharmaceuticals","regulator":"none"},{"date":"2005-07-01","type":"positive","milestone":"Phase 1 clinical trials initiated","regulator":"none"},{"date":"2006-01-01","type":"positive","milestone":"Phase 2 clinical trials initiated","regulator":"none"},{"date":"2008-01-01","type":"positive","milestone":"Phase 3 clinical trials initiated","regulator":"none"},{"date":"2010-09-21","type":"positive","milestone":"FDA approval for multiple sclerosis","regulator":"FDA"},{"date":"2011-01-19","type":"positive","milestone":"EMA approval for multiple sclerosis","regulator":"EMA"},{"date":"2015-01-01","type":"negative","milestone":"US Patent and Trademark Office invalidates Novartis's patent claims","regulator":"none"},{"date":"2017-04-01","type":"negative","milestone":"Federal Circuit upholds patent office decision","regulator":"none"},{"date":"2020-01-01","type":"negative","milestone":"Court of Appeal questions validity of last remaining orange book patent","regulator":"none"},{"date":"2022-10-01","type":"negative","milestone":"Supreme Court declines to block generic versions of Gilenya","regulator":"none"},{"date":"2023-04-01","type":"negative","milestone":"U.S. Supreme Court declines to hear Novartis's request to revive key patent","regulator":"none"}],"_dailymed":null,"aiSummary":"Fingolimod (FTY720/Gilenya) is Novartis's marketed sphingosine-1-phosphate receptor modulator for relapsing forms of multiple sclerosis. The drug reduces clinical exacerbations and delays disability progression by sequestering lymphocytes in lymph nodes, preventing autoimmune attack on the central nervous system. With 100 clinical trials and 2,047 publications, fingolimod represents a significant advancement in MS treatment, reducing relapse rates by approximately 50% over two years. As a first-in-class oral immunomodulator, it established a new therapeutic paradigm for MS management and maintains strong commercial relevance in the competitive MS market.","ecosystem":[],"mechanism":{"target":"Sphingosine-1-phosphate receptors (S1P1, S1P3, S1P4, S1P5)","novelty":"first-in-class","modality":"small molecule","drugClass":"Sphingosine-1-phosphate receptor modulator; Immunomodulator","explanation":"","oneSentence":"","technicalDetail":"Fingolimod is a prodrug phosphorylated by sphingosine kinase-2 to its active form, which acts as a high-affinity agonist at S1P1, S1P3, S1P4, and S1P5 receptors. S1P1 receptor activation on lymphocytes triggers receptor internalization and degradation, functionally antagonizing S1P-mediated egress signals. This results in a 40-60% reduction in circulating lymphocytes within hours, with maximal effect at 4-6 weeks. The mechanism is reversible; lymphocyte counts normalize within 1-2 months after drug discontinuation."},"_scrapedAt":"2026-03-27T23:30:18.643Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"title":"Fingolimod","extract":"Fingolimod, sold under the brand name Gilenya, is an immunomodulating medication, used for the treatment of multiple sclerosis. Fingolimod is a sphingosine-1-phosphate receptor modulator, which sequesters lymphocytes in lymph nodes, preventing them from contributing to an autoimmune reaction. It has been reported to reduce the rate of relapses in relapsing-remitting multiple sclerosis by approximately one-half over a two-year period.","wiki_history":"==History==\nFirst synthesized in 1992 by Yoshitomi Pharmaceuticals, fingolimod was derived from an immunosuppressive natural product, myriocin (ISP-I)  through chemical modification.  Myriocin was isolated from the culture broth a type of entomopathogenic fungus (Isaria sinclairii) that was an eternal youth nostrum in traditional Chinese medicine. Showing positive results in both in vitro (mixed lymphocyte reaction) and in vivo screening (prolonging rat skin graft survival time), myriocin was modified through a series of steps to yield fingolimod, code named at the time FTY720. A recent review highlights the synthetic methods, mode of action and potential applications of this molecule.\nStructure activity relationship (SAR) studies on myriocin homologs and partially synthetic derivatives showed that the configuration at the carbon bearing the 3-hydroxy group or the 14-ketone, the 6-double bond, and the 4-hydroxy group were not important for its activity and simplification of the structure of ISP-I was done in an attempt to reduce toxicity and improve drug ability. In April 2011 Novartis said that the drug would be available in Canadian pharmacies. In March 2011, the European Medicines Agency approved the drug for use in the European Union.\n\nIn 2016, a systematic review concluded that treatment of people relapsing-remitting multiple sclerosis is effective in reducing the probability of acute inflammatory relapses, with potentially little or no effect on disability progression, ","wiki_medical_uses":"==Medical uses==\nFingolimod is used in the treatment of the relapsing form of multiple sclerosis.<!-- ","wiki_society_and_culture":"== Society and culture ==\n=== Legal status ===\nIn 2015, after a challenge at the US Patent and Trademark Office by a generic competitor, the patent office quashed Novartis's patent claims stating they were obvious. Novartis appealed and the federal circuit upheld the patent office decision in April 2017, leaving a high likelihood of generics coming to market by 2019.\n\nIn January 2020, a panel of judges at the Court of Appeal for the Federal Circuit called into question the validity of the last remaining orange book patent protecting Gilenya.\n\nIn October 2022, the Supreme Court turned down a request by Novartis to block the launch of generic versions of Gilenya in the United States.\n\nIn April 2023, the U.S. Supreme Court declined to hear Novartis's request to revive a key patent on Gilenya that had been invalidated by a lower court."},"commercial":{"annualCostUS":"$48,000/yr","peakSalesEstimate":"Not publicly reported"},"references":[],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:34:00.264290+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Interferons","company":"Various","advantage":"Approved for MS, targets immunomodulation"},{"name":"Glatiramer Acetate","company":"Various","advantage":"Approved for MS, targets immunomodulation"},{"name":"Fumarates","company":"Various","advantage":"Approved for MS, targets immunomodulation"},{"name":"Cladribine","company":"Various","advantage":"Approved for MS, targets immunomodulation"},{"name":"Teriflunomide","company":"Sanofi","advantage":"Approved for MS, targets immunomodulation"},{"name":"Siponimod","company":"Novartis","advantage":"Approved for MS, targets S1P receptors"},{"name":"Ozanimod","company":"Bristol Myers Squibb","advantage":"Approved for MS, targets S1P receptors"},{"name":"Ponesimod","company":"Janssen","advantage":"Approved for MS, targets S1P receptors"},{"name":"Monoclonal Antibodies (targeting ITGA4, CD20, CD52)","company":"Various","advantage":"Approved for MS, targets specific immune cells"}],"indications":{"approved":[{"name":"Treatment of relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07483632","phase":"PHASE3","title":"A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)","status":"NOT_YET_RECRUITING","sponsor":"Biogen","startDate":"2026-11-16","conditions":"Relapsing Forms of Multiple Sclerosis","enrollment":185},{"nctId":"NCT04480853","phase":"PHASE4","title":"Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 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Rouen","startDate":"2020-07-13","conditions":"Multiple Sclerosis","enrollment":77},{"nctId":"NCT06408259","phase":"PHASE3","title":"Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis","status":"RECRUITING","sponsor":"Celgene","startDate":"2025-04-08","conditions":"Multiple Sclerosis, Relapsing-Remitting","enrollment":194},{"nctId":"NCT05123703","phase":"PHASE3","title":"A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2022-05-19","conditions":"Relapsing-Remitting Multiple Sclerosis","enrollment":188},{"nctId":"NCT04667949","phase":"PHASE4","title":"Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2021-02-20","conditions":"Relapsing Multiple Sclerosis (RMS)","enrollment":98},{"nctId":"NCT01892722","phase":"PHASE3","title":"Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2013-07-26","conditions":"Multiple Sclerosis","enrollment":240},{"nctId":"NCT04353492","phase":"PHASE3","title":"An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2020-07-14","conditions":"Relapsing Multiple Sclerosis","enrollment":562},{"nctId":"NCT05688436","phase":"","title":"A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of 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Inc.","startDate":"2025-06-01","conditions":"Relapsing Remitting Multiple Sclerosis","enrollment":140},{"nctId":"NCT03193866","phase":"","title":"COMparison Between All immunoTherapies for Multiple Sclerosis.","status":"COMPLETED","sponsor":"Karolinska Institutet","startDate":"2017-06-02","conditions":"Relapsing-remitting Multiple Sclerosis","enrollment":3526},{"nctId":"NCT05285878","phase":"PHASE2","title":"Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation","status":"ENROLLING_BY_INVITATION","sponsor":"The Methodist Hospital Research Institute","startDate":"2022-07-28","conditions":"Interstitial Fibrosis, Kidney Transplant; Complications, Kidney Transplant Rejection","enrollment":20},{"nctId":"NCT05269888","phase":"","title":"Covid-19 Vaccine Immune Response in Multiple Sclerosis","status":"ACTIVE_NOT_RECRUITING","sponsor":"University Hospitals of North Midlands NHS Trust","startDate":"2022-02-16","conditions":"Multiple Sclerosis","enrollment":240},{"nctId":"NCT04088630","phase":"EARLY_PHASE1","title":"Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage","status":"COMPLETED","sponsor":"Wake Forest University Health Sciences","startDate":"2020-08-07","conditions":"Intracerebral Hemorrhage, Cerebral Edema, Stroke Hemorrhagic","enrollment":28},{"nctId":"NCT01285479","phase":"","title":"The Gilenya Pregnancy Registry","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2011-10-15","conditions":"Multiple Sclerosis","enrollment":312},{"nctId":"NCT06705608","phase":"","title":"Examining the Risk of Skin Cancer in Multiple Sclerosis Patients Using Fingolimod: a Population-Based Study","status":"COMPLETED","sponsor":"University of British Columbia","startDate":"2003-01-01","conditions":"Multiple Sclerosis, Skin Cancer, Skin Cancer Melanoma","enrollment":4000},{"nctId":"NCT05718947","phase":"","title":"Ultra-high-field Brain MRI in Multiple Sclerosis","status":"COMPLETED","sponsor":"Zuyderland Medisch Centrum","startDate":"2023-09-12","conditions":"Multiple Sclerosis","enrollment":10},{"nctId":"NCT05423769","phase":"","title":"Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt","status":"COMPLETED","sponsor":"Hikma Pharmaceuticals LLC","startDate":"2022-01-19","conditions":"Relapsing-Remitting Multiple Sclerosis","enrollment":30},{"nctId":"NCT03623243","phase":"PHASE3","title":"Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2019-02-14","conditions":"Multiple Sclerosis, Relapsing Multiple Sclerosis, Advancing Multiple Sclerosis","enrollment":185},{"nctId":"NCT04472975","phase":"","title":"Prescription Drug Safety and Effectiveness in Multiple Sclerosis","status":"COMPLETED","sponsor":"University of British Columbia","startDate":"1996-01-01","conditions":"Multiple Sclerosis","enrollment":35000},{"nctId":"NCT03399981","phase":"","title":"Tysabri Observational Cohort Study - Multiple Sclerosis (MS) Registries","status":"COMPLETED","sponsor":"Biogen","startDate":"2017-06-01","conditions":"Progressive Multifocal Leukoencephalopathy","enrollment":80327},{"nctId":"NCT05060354","phase":"","title":"COVID-19 Vaccine Response in Treated MS Patients","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2021-06-01","conditions":"Multiple Sclerosis, Healthy","enrollment":159},{"nctId":"NCT05112484","phase":"","title":"Therapeutic Monitoring of Drugs Used in the Treatment of Multiple Sclerosis","status":"NOT_YET_RECRUITING","sponsor":"University Hospital Ostrava","startDate":"2024-06","conditions":"Multiple Sclerosis","enrollment":600},{"nctId":"NCT06087965","phase":"PHASE1, PHASE2","title":"Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage","status":"UNKNOWN","sponsor":"Tang-Du Hospital","startDate":"2023-10-11","conditions":"Intracerebral Hemorrhage","enrollment":40},{"nctId":"NCT03943498","phase":"EARLY_PHASE1","title":"Fingolimod in Treating Patients With Chemotherapy-Induced Neuropathy","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2019-05-24","conditions":"Chemotherapy-Induced Peripheral Neuropathy, Numbness, Pain","enrollment":2},{"nctId":"NCT03941743","phase":"PHASE1","title":"Fingolimod in Preventing Paclitaxel-Associated Neuropathy in Patients With Breast Cancer","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2019-12-12","conditions":"Breast Carcinoma","enrollment":2},{"nctId":"NCT04675762","phase":"PHASE2","title":"Combinating Fingolimod With Alteplase Bridging With Thrombectomy in Acute Ischemic Stroke","status":"UNKNOWN","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2021-01-15","conditions":"Stroke, Inflammation","enrollment":118},{"nctId":"NCT04796584","phase":"","title":"Efficacy of COVID-19 Vaccination in Patients With Multiple Sclerosis Treated With Immune Modulating Medication","status":"TERMINATED","sponsor":"Providence Health & Services","startDate":"2022-07-11","conditions":"Multiple Sclerosis","enrollment":20},{"nctId":"NCT05762003","phase":"","title":"Czech Pharmaco-epidemiological Study on Disease Modifying Drugs","status":"COMPLETED","sponsor":"IMPULS Endowment Fund","startDate":"2019-01-01","conditions":"Multiple Sclerosis","enrollment":17478},{"nctId":"NCT05684016","phase":"NA","title":"Assessment of Deep Gray Matter Anatomic Changes in RRMS Patients Treated With Gilenya® With and Without Cognitive Impairment Over a 2 Year Period Using NeuroQuant, NeuroQuarc and ANAM","status":"COMPLETED","sponsor":"George Washington University","startDate":"2013-12","conditions":"Multiple Sclerosis, 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Sclerosis","enrollment":157},{"nctId":"NCT01442194","phase":"","title":"Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2011-08-01","conditions":"Multiple Sclerosis","enrollment":3076},{"nctId":"NCT05145621","phase":"PHASE1","title":"Oral Bio-equivalence Study","status":"COMPLETED","sponsor":"Alembic Pharmaceuticals Ltd.","startDate":"2015-10-29","conditions":"Bioequivalence, Safety","enrollment":26},{"nctId":"NCT05141669","phase":"","title":"Impact of Fingolimod Adherence on Outcomes","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2020-05-18","conditions":"Multiple Sclerosis","enrollment":694},{"nctId":"NCT03257358","phase":"PHASE4","title":"A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2017-09-19","conditions":"Relapsing Multiple Sclerosis","enrollment":382},{"nctId":"NCT03243721","phase":"NA","title":"Gilenya's Impact on Cognitive Function and Thalamic Volumes","status":"COMPLETED","sponsor":"The Cleveland Clinic","startDate":"2017-10-20","conditions":"Multiple Sclerosis","enrollment":20},{"nctId":"NCT01647880","phase":"PHASE2, PHASE3","title":"MOdification of VIsual Outcomes After Optic Neuritis in CIS or MS by Gilenya (MOVING Study)","status":"TERMINATED","sponsor":"Charite University, Berlin, Germany","startDate":"2013-07","conditions":"Multiple Sclerosis","enrollment":15},{"nctId":"NCT01790269","phase":"","title":"Monitoring Natural Killer Cells in Multiple Sclerosis Patients Treated With Fingolimod","status":"TERMINATED","sponsor":"Charite University, Berlin, Germany","startDate":"2013-09","conditions":"Relapsing-Remitting Multiple Sclerosis","enrollment":21},{"nctId":"NCT02956200","phase":"PHASE2","title":"Combinating Fingolimod With Alteplase Bridging With Mechanical Thrombectomy in Acute Ischemic Stroke","status":"WITHDRAWN","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2016-11","conditions":"Stroke, Inflammation","enrollment":0},{"nctId":"NCT01201356","phase":"PHASE3","title":"Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2010-09-13","conditions":"Relapsing Forms of Multiple Sclerosis","enrollment":4125},{"nctId":"NCT02232061","phase":"PHASE4","title":"Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2014-09-29","conditions":"Multiple Sclerosis","enrollment":6},{"nctId":"NCT04718064","phase":"NA","title":"Revascularization Pretreated With Fingolimod in Acute Stroke","status":"UNKNOWN","sponsor":"The Affiliated Hospital of 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