{"id":"odalasvir-75-mg","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":[{"drug":"Simeprevir","action":"Monitor","effect":"No major pharmacokinetic interaction observed in combination studies"},{"drug":"AL-335","action":"Monitor","effect":"No major pharmacokinetic interaction observed in combination studies"}],"commonSideEffects":[],"contraindications":[],"specialPopulations":{"Pregnancy":"Data not available","Geriatric use":"Data not available","Paediatric use":"Data not available","Renal impairment":"Data not available","Hepatic impairment":"One Phase 1 study (withdrawn) was designed to investigate pharmacokinetics and safety in hepatic impairment; no results published"},"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT03059303"],"_pubmed":{"count":0,"papers":[]},"_rxnorm":{"forms":[]},"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2012","type":"neutral","milestone":"Phase 1 pharmacokinetic interaction studies initiated","regulator":"none","description":"Early-stage clinical evaluation of odalasvir alone and in combination with other DAAs in healthy volunteers"},{"date":"2013","type":"positive","milestone":"Phase 1 cardiac safety study completed","regulator":"none","description":"59-patient study demonstrated acceptable cardiac safety profile of AL-335 on background of simeprevir and odalasvir"},{"date":"2014","type":"positive","milestone":"Phase 2 efficacy and safety trial completed (365 patients)","regulator":"none","description":"Combination of AL-335, odalasvir, and simeprevir showed efficacy in chronic hepatitis C; however, results did not differentiate from competing regimens"},{"date":"2015","type":"neutral","milestone":"Phase 2 Japanese population study completed (33 patients)","regulator":"none","description":"Safety and efficacy evaluation in Japanese patients with chronic hepatitis C; limited sample size"},{"date":"2015","type":"positive","milestone":"Phase 2 treatment-naïve and treatment-experienced study completed (161 patients)","regulator":"none","description":"Alios Biopharma-sponsored trial demonstrated efficacy of AL-335/odalasvir/simeprevir combination across patient populations"},{"date":"2016","type":"negative","milestone":"Program discontinued","regulator":"none","description":"Janssen discontinued odalasvir development as pangenotypic DAA combinations (glecaprevir/pibrentasvir, sofosbuvir/velpatasvir) demonstrated superior efficacy and simpler dosing; Phase 3 trials not initiated"}],"_drugbank":{"source":"DrugBank","halfLife":"","metabolism":"","proteinBinding":"","bioavailability":""},"aiSummary":"Odalasvir 75 mg is a hepatitis C virus (HCV) NS5A inhibitor developed by Janssen Research & Development that was discontinued before FDA approval. The drug was designed to inhibit the NS5A protein, a multifunctional regulator essential for HCV replication and virion assembly, and was evaluated in combination with other direct-acting antivirals (DAAs) including simeprevir and AL-335. Clinical development included 9 trials across Phase 1 and Phase 2, with Phase 2 data demonstrating efficacy in chronic hepatitis C patients when combined with other DAAs; however, the program was terminated as the competitive HCV landscape shifted toward all-oral, fixed-dose combination regimens with superior efficacy and tolerability profiles. The discontinuation reflects the rapid evolution of HCV therapeutics and Janssen's strategic pivot away from this particular combination approach in favor of more advanced DAA regimens. No approved indications, revenue, or commercial data exist for this asset.","brandName":"Odalasvir 75 mg","companyId":"johnson-johnson","ecosystem":[],"mechanism":{"target":"Hepatitis C virus NS5A protein","novelty":"me-too","modality":"small molecule","drugClass":"Direct-acting antiviral (DAA); NS5A inhibitor","explanation":"Odalasvir is a direct-acting antiviral (DAA) that targets the NS5A protein of hepatitis C virus. NS5A is a multifunctional, zinc-binding phosphoprotein that plays critical roles in HCV RNA replication, virion assembly, and host cell interactions. By binding to and inhibiting NS5A, odalasvir disrupts the viral replication complex, preventing the virus from making copies of itself and assembling infectious particles. This mechanism is distinct from protease inhibitors (which block viral protein processing) and polymerase inhibitors (which block RNA synthesis), allowing odalasvir to be combined with drugs targeting other viral proteins for enhanced antiviral activity. The drug was developed as part of a multi-DAA combination strategy to achieve high cure rates in hepatitis C patients across different viral genotypes.","oneSentence":"Odalasvir inhibits hepatitis C virus NS5A protein to block viral replication and assembly.","technicalDetail":"Odalasvir is a potent, selective NS5A inhibitor with picomolar to nanomolar inhibitory activity against HCV NS5A from multiple genotypes. The drug exhibits oral bioavailability and was formulated as a 75 mg tablet for clinical evaluation. Pharmacokinetic studies demonstrated that odalasvir can be combined with other DAAs (simeprevir, AL-335) without major drug-drug interactions, supporting its use in fixed-dose combination regimens. The NS5A target is highly conserved across HCV genotypes, providing broad-spectrum antiviral coverage."},"commercial":{"notes":"Drug was discontinued before FDA approval; no commercial data available","yoyGrowth":"","launchDate":"","marketShare":"","revenueYear":"","annualCostUS":"","currentRevenue":"","percentOfCompany":"","patientPopulation":"","peakSalesEstimate":"","genericCompetition":"no"},"references":[],"biosimilars":[],"companyName":"Janssen Research & Development, LLC","competitors":[{"name":"Sofosbuvir/Velpatasvir","slug":"sofosbuvir-velpatasvir","company":"Gilead Sciences","advantage":"FDA-approved fixed-dose combination with superior efficacy and simpler dosing; established market leader"},{"name":"Glecaprevir/Pibrentasvir","slug":"glecaprevir-pibrentasvir","company":"AbbVie","advantage":"Pangenotypic DAA combination with high cure rates across all HCV genotypes; approved for treatment-naïve and treatment-experienced patients"},{"name":"Sofosbuvir/Velpatasvir/Voxilaprevir","slug":"sofosbuvir-velpatasvir-voxilaprevir","company":"Gilead Sciences","advantage":"Triple DAA combination for treatment-experienced patients; addresses resistance-associated variants"},{"name":"Simeprevir","slug":"simeprevir","company":"Janssen Pharmaceuticals","advantage":"Protease inhibitor; was being combined with odalasvir in clinical trials but ultimately replaced by more effective DAA combinations"}],"genericName":"Odalasvir 75 mg","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Chronic hepatitis C (genotype 1)","notes":"Evaluated in combination with AL-335 and simeprevir in 365-patient trial; program discontinued before Phase 3 initiation","phase":"Phase 2","status":"completed"},{"name":"Chronic hepatitis C (treatment-naïve and treatment-experienced)","notes":"Studied in 161-patient trial sponsored by Alios Biopharma; combination regimen showed efficacy but development halted","phase":"Phase 2","status":"completed"},{"name":"Chronic hepatitis C (Japanese population)","notes":"33-patient trial conducted by Janssen Pharmaceutical K.K.; program discontinued","phase":"Phase 2","status":"completed"}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02824315","phase":"PHASE1","title":"Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State in Healthy Japanese Participants","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2016-05","conditions":"Healthy","enrollment":22,"completionDate":"2016-10","primaryEndpoint":"Average Analyte Concentration at Steady State (Cavg,ss)"},{"nctId":"NCT02945020","phase":"PHASE1","title":"A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2016-11-10","conditions":"Healthy","enrollment":15,"completionDate":"2017-01-20","primaryEndpoint":"Maximum Observed Analyte Concentration (Cmax) of Dabigatran"},{"nctId":"NCT02765490","phase":"PHASE2","title":"Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2016-11-09","conditions":"Hepatitis C, Chronic","enrollment":365,"completionDate":"2017-11-16","primaryEndpoint":"Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)"},{"nctId":"NCT02993250","phase":"PHASE2","title":"A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive","status":"COMPLETED","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2016-12-21","conditions":"Hepatitis C, Chronic","enrollment":33,"completionDate":"2018-05-07","primaryEndpoint":"Number of Participants With Adverse Events (AEs)"},{"nctId":"NCT02569710","phase":"PHASE2","title":"A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir","status":"COMPLETED","sponsor":"Alios Biopharma Inc.","startDate":"2015-10-31","conditions":"Chronic Hepatitis C","enrollment":161,"completionDate":"2018-05-11","primaryEndpoint":"Number of Participants With Treatment Emergent Adverse Event (TEAE)"},{"nctId":"NCT03059303","phase":"PHASE1","title":"Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC)","status":"TERMINATED","sponsor":"Janssen Research & Development, LLC","startDate":"2017-02-20","conditions":"Healthy","enrollment":72,"completionDate":"2017-04-24","primaryEndpoint":"Part 1: Maximum Observed Plasma Concentration (Cmax) of Simeprevir (SMV)"},{"nctId":"NCT03155893","phase":"PHASE1","title":"A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Participants","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2017-05-12","conditions":"Healthy","enrollment":59,"completionDate":"2017-10-27","primaryEndpoint":"Panel 1:Effect of AL-335 Single Supratherapeutic Dose on QT/QTc Interval Change on top of Multiple Doses of ODV and SMV Vs. Placebo Using IUT Analysis at Day 16"},{"nctId":"NCT03277755","phase":"PHASE1","title":"A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Odalasvir and AL-335 Alone and in Combination With Simeprevir in Participants With Moderately Impaired Hepatic Function","status":"WITHDRAWN","sponsor":"Janssen Research & Development, LLC","startDate":"2017-09-11","conditions":"Hepatic Impairment","enrollment":0,"completionDate":"2017-12-22","primaryEndpoint":"Part 1: Maximum Observed Plasma Concentration (Cmax) of AL-335 and its Metabolites ALS-022399 and ALS-022227"},{"nctId":"NCT02885454","phase":"PHASE1","title":"To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2016-08","conditions":"Healthy","enrollment":24,"completionDate":"2016-12","primaryEndpoint":"Maximum Observed Analyte Concentration (Cmax) of Drospirenone"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"💊","route":"oral","frequency":"Data not available","formulation":"Tablet, 75 mg"},"_hyperScrapedAt":"2026-03-27T18:18:42.657396","formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[{"notes":"Developed odalasvir as part of HCV DAA pipeline; program discontinued as competitive landscape shifted toward pangenotypic, fixed-dose combinations","period":"2010–2018","companyName":"Janssen Research & Development, LLC","relationship":"Originator"}],"therapeuticAreas":["Infectious Disease"],"trialPhaseCounts":{"PHASE1":6,"PHASE2":3},"biosimilarFilings":[],"firstApprovalDate":"","_hyperScrapedFields":["patents","pricing","trials","ema","mhra","who","safety-signals","recalls","dailymed","pubmed","drugbank","chembl","rxnorm","medicare","pharmgkb","sec","company-ir","wikipedia","drug-website","google"],"companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}