{"id":"alisporivir","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT01215643","NCT01500772","NCT02094443","NCT02173574","NCT02753699","NCT01446250","NCT04608214","NCT01860326","NCT02465203","NCT00854802","NCT01318694","NCT01970904","NCT01183169","NCT00537407","NCT01975337"],"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2010","type":"neutral","milestone":"Phase 2 Initiated","description":"A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-r — Chronic Hepatitis C"},{"date":"2011","type":"neutral","milestone":"Phase 1 Initiated","description":"Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impa — Hepatic Insufficiency"},{"date":"2012","type":"negative","milestone":"Phase 3 Initiated","description":"Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepa — Hepatitis C. Trial terminated early."}],"aiSummary":"Alisporivir is an investigational antiviral targeting hepatitis C virus (HCV) replication. It was studied in Phase 2 trials for chronic HCV genotype infections, often in combination with ribavirin or pegylated interferon. A key differentiator is its evaluation in patients who cannot tolerate interferon-based regimens.","brandName":"ALISPORIVIR","companyId":"unknown","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"Recombinant protein","drugClass":"","explanation":"Alisporivir is being studied as a treatment for chronic hepatitis C virus infection. It works by targeting the virus's ability to replicate inside liver cells. The drug has been tested in people with different hepatitis C genotypes, often alongside other antiviral medications like ribavirin or pegylated interferon. Researchers are particularly interested in using it for patients who cannot take interferon-based treatments due to side effects or other health reasons.","oneSentence":"Alisporivir is an experimental hepatitis C drug tested in small Phase 2 trials for patients with chronic HCV infection.","technicalDetail":"Alisporivir is an investigational antiviral agent that inhibits hepatitis C virus replication. It has been evaluated in Phase 2 clinical trials for chronic HCV genotype infections, typically in combination with ribavirin or pegylated interferon-alpha. The drug's mechanism involves targeting viral replication pathways, though specific molecular targets are not detailed in the provided text."},"commercial":null,"references":[],"biosimilars":[],"companyName":"","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"}],"genericName":"ALISPORIVIR","indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT01215643","phase":"Phase 2","title":"A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a P","status":"COMPLETED","sponsor":"Debiopharm International SA","isPivotal":false,"enrollment":340,"indication":"Hepatitis C, Chronic Pain","completionDate":"2012-05"},{"nctId":"NCT01500772","phase":"Phase 3","title":"A Multicenter, Single-arm Trial Evaluating the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-IFNα2a/RBV) in Protease Inhibitor Treatment Fai","status":"TERMINATED","sponsor":"Debiopharm International SA","isPivotal":true,"enrollment":6,"indication":"Hepatitis C","completionDate":"2012-05"},{"nctId":"NCT02094443","phase":"Phase 2","title":"A Multicenter, Open-label, Randomized, 2-arm, Phase II Trial of Pharmacodynamics, Pharmacokinetics and Safety of Two Dose Regimens of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chroni","status":"COMPLETED","sponsor":"Debiopharm International SA","isPivotal":false,"enrollment":52,"indication":"Hepatitis C, Liver Disease","completionDate":"2015-04"},{"nctId":"NCT02173574","phase":"Phase 1","title":"An Open-label, Two Part Investigation of the Pharmacokinetics, Safety, and Tolerability of Alisporivir and EDP239 When Co-administered to Healthy Adult Subjects","status":"COMPLETED","sponsor":"Enanta Pharmaceuticals, Inc","isPivotal":false,"enrollment":42,"indication":"Hepatitis C Virus","completionDate":"2014-11"},{"nctId":"NCT02753699","phase":"Phase 3","title":"A Multi-centre Long Term Follow-up Study to Assess the Durability of Sustained Virologic Response in Alisporivir-treated Chronic Hepatitis C Patients","status":"COMPLETED","sponsor":"Debiopharm International SA","isPivotal":true,"enrollment":723,"indication":"Hepatitis C","completionDate":"2015-05"},{"nctId":"NCT01446250","phase":"Phase 3","title":"A Randomized, Open Label Trial of the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-INFα2a/RBV) and Boceprevir in Combination With Peg-INFα2","status":"TERMINATED","sponsor":"Debiopharm International SA","isPivotal":true,"enrollment":8,"indication":"Hepatitis C","completionDate":"2013-05"},{"nctId":"NCT04608214","phase":"Phase 2","title":"Evaluation of the Efficacy, Safety and Tolerability of Alisporivir for the Treatment of Hospitalised Patients With Infections Due to SARS-CoV-2 (COVID-19). A Randomised, Open-label, Proof of Concept, ","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","isPivotal":false,"enrollment":26,"indication":"SARS-CoV-2","completionDate":"2022-04-13"},{"nctId":"NCT01860326","phase":"Phase 1","title":"An Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Single Oral Doses of DEB025 in Subjects With Mild and Moderate Hepatic Impairment Compared to Matched Healthy Subjects ","status":"COMPLETED","sponsor":"Debiopharm International SA","isPivotal":false,"enrollment":32,"indication":"Hepatic Insufficiency","completionDate":"2011-09"},{"nctId":"NCT02465203","phase":"Phase 3","title":"A Multi-centre 3-year Follow-up Study to Assess the Viral Activity in Patients Who Failed to Achieve Sustained Virologic Response in Novartis-sponsored Alisporivir-studies for Chronic Hepatitis C Pati","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","isPivotal":true,"enrollment":105,"indication":"Hepatitis C, Chronic","completionDate":"2014-01-23"},{"nctId":"NCT00854802","phase":"NA","title":"A Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Phase II Study on the Efficacy and Safety of Debio 025 Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hep","status":"COMPLETED","sponsor":"Debiopharm International SA","isPivotal":false,"enrollment":290,"indication":"Chronic Hepatitis C","completionDate":"2010-09"},{"nctId":"NCT01318694","phase":"Phase 3","title":"A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFNα2a and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve Patients","status":"COMPLETED","sponsor":"Debiopharm International SA","isPivotal":true,"enrollment":1081,"indication":"Hepatitis C","completionDate":"2013-08"},{"nctId":"NCT01970904","phase":"NA","title":"A Multicenter, Open-label, Randomized, 3-arm, Phase II Profiling Trial of Pharmacokinetics, Pharmacodynamics and Safety of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis","status":"COMPLETED","sponsor":"Debiopharm International SA","isPivotal":false,"enrollment":147,"indication":"Hepatitis C, Liver Disease","completionDate":"2015-03"},{"nctId":"NCT01183169","phase":"Phase 2","title":"A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype ","status":"COMPLETED","sponsor":"Debiopharm International SA","isPivotal":false,"enrollment":459,"indication":"Hepatitis C","completionDate":"2013-05"},{"nctId":"NCT00537407","phase":"Phase 2","title":"An Open-label, Randomized, 5-arm, Parallel-group Study of the Effects on Viral Kinetics, Safety and Pharmacokinetics of Different Dosing Regimens of Debio 025 in Combination With Peginterferon Alpha-2","status":"COMPLETED","sponsor":"Debiopharm International SA","isPivotal":false,"enrollment":50,"indication":"Chronic Hepatitis C","completionDate":"2010-04"},{"nctId":"NCT01975337","phase":"Phase 1","title":"An Open-label Study to Evaluate the Pharmacokinetics and Safety of a Single Oral Dose of Alisporivir (DEB025) in Subjects With End Stage Renal Disease on Hemodialysis Compared to Matched Healthy Subje","status":"COMPLETED","sponsor":"Debiopharm International SA","isPivotal":false,"enrollment":16,"indication":"Kidney Failure, Chronic","completionDate":"2014-02"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Infectious Disease"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Recombinant protein","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}