{"id":"odalasvir-25-mg","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{"Pregnancy":"Data not available","Geriatric use":"Data not available","Paediatric use":"Data not available","Renal impairment":"Completed Phase 1 study in severe renal impairment (N=16) with no dose adjustment recommended based on pharmacokinetic findings","Hepatic impairment":"Phase 1 study withdrawn; limited data available on use in hepatic impairment"},"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT03059303"],"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2014","type":"neutral","milestone":"Phase 1 renal impairment study initiated","regulator":"none","description":"Pharmacokinetic study evaluating odalasvir in patients with severe renal impairment completed with N=16 participants"},{"date":"2014","type":"neutral","milestone":"Phase 1 pharmacokinetic interaction study completed","regulator":"none","description":"Drug-drug interaction study between odalasvir and other agents completed in healthy volunteers (N=15)"},{"date":"2014","type":"negative","milestone":"Phase 1 fixed-dose combination bioavailability study terminated","regulator":"none","description":"Study assessing relative bioavailability of simeprevir/odalasvir FDC tablet terminated early (N=72 enrolled)"},{"date":"2014","type":"neutral","milestone":"Phase 1 cardiac safety study completed","regulator":"none","description":"Cardiac safety evaluation of AL-335 on background of simeprevir and odalasvir completed in healthy volunteers (N=59)"},{"date":"2014","type":"negative","milestone":"Phase 1 hepatic impairment study withdrawn","regulator":"none","description":"Pharmacokinetics and safety study in hepatic impairment withdrawn before enrollment"},{"date":"2014","type":"neutral","milestone":"Phase 1 triple-agent pharmacokinetics study completed","regulator":"none","description":"Study evaluating effects of odalasvir and AL-335 with simeprevir on single-dose pharmacokinetics completed (N=24)"},{"date":"2015","type":"positive","milestone":"Phase 2 efficacy and safety trial completed","regulator":"none","description":"Large Phase 2 study of AL-335/odalasvir/simeprevir combination in chronic hepatitis C completed with N=365 patients demonstrating efficacy"},{"date":"2015","type":"positive","milestone":"Phase 2 Japanese hepatitis C trial completed","regulator":"none","description":"Phase 2 safety and efficacy study of AL-335/odalasvir combination in Japanese patients with chronic hepatitis C completed (N=33)"},{"date":"2015","type":"positive","milestone":"Phase 2 chronic hepatitis C trial completed","regulator":"none","description":"Phase 2 efficacy and safety study of AL-335/odalasvir/simeprevir in chronic hepatitis C completed with N=161 patients"},{"date":"2016","type":"negative","milestone":"Development program discontinued","regulator":"none","description":"Odalasvir development discontinued; no Phase 3 trials initiated; competitive HCV landscape with established DAA combinations reduced commercial viability"}],"aiSummary":"Odalasvir 25 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 critical non-structural protein required for HCV replication and virion assembly, and was being evaluated in combination with other direct-acting antivirals (DAAs) including simeprevir and AL-335. Clinical development progressed through Phase 2 trials demonstrating efficacy in chronic hepatitis C patients, with 9 total trials completed or terminated across Phase 1 and Phase 2. The discontinuation reflects the competitive HCV landscape where multiple all-oral, fixed-dose combination regimens with superior efficacy and tolerability profiles (such as sofosbuvir/velpatasvir/voxilaprevir) achieved market dominance, reducing commercial viability for new entrants. Odalasvir never achieved regulatory approval and remains a discontinued development asset with no commercial revenue or market presence.","brandName":"Odalasvir 25 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. The NS5A protein is a multifunctional, zinc-binding phosphoprotein essential for HCV RNA replication and the formation of infectious viral particles. By binding to and inhibiting NS5A, odalasvir disrupts the viral replication complex and prevents the assembly and secretion of new HCV virions. This mechanism allows the drug to reduce viral load in infected patients. The drug was developed as part of a combination therapy strategy, where multiple DAAs with different mechanisms (protease inhibitors, polymerase inhibitors, NS5A inhibitors) are used together to maximize efficacy and minimize resistance development.","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 in vitro activity against HCV genotypes 1–6. The drug exhibits oral bioavailability and is metabolized hepatically. Pharmacokinetic studies demonstrated dose-proportional exposure and minimal renal clearance, with completed trials in renal and hepatic impairment populations. The compound was evaluated in fixed-dose combinations with simeprevir (NS3/4A protease inhibitor) and AL-335 (nucleoside polymerase inhibitor) to achieve pangenotypic coverage and high barrier to resistance."},"commercial":{"notes":"Drug was discontinued before FDA approval; no commercial revenue generated","yoyGrowth":"","launchDate":"","marketShare":"","revenueYear":"","annualCostUS":"","currentRevenue":"","percentOfCompany":"","patientPopulation":"","peakSalesEstimate":"","genericCompetition":"no"},"references":[],"biosimilars":[],"companyName":"Janssen Research & Development, LLC","competitors":[{"name":"Sofosbuvir/velpatasvir/voxilaprevir","slug":"sofosbuvir-velpatasvir-voxilaprevir","company":"Gilead Sciences","advantage":"FDA-approved pangenotypic fixed-dose combination with superior efficacy and tolerability; established market dominance"},{"name":"Glecaprevir/pibrentasvir","slug":"glecaprevir-pibrentasvir","company":"AbbVie","advantage":"FDA-approved pangenotypic DAA combination with high cure rates and shorter treatment duration"},{"name":"Sofosbuvir/velpatasvir","slug":"sofosbuvir-velpatasvir","company":"Gilead Sciences","advantage":"Established fixed-dose combination with broad genotype coverage and favorable safety profile"},{"name":"Simeprevir","slug":"simeprevir","company":"Janssen Pharmaceuticals","advantage":"NS3/4A protease inhibitor; used in combination regimens; developed by same company as odalasvir"}],"genericName":"Odalasvir 25 mg","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Chronic hepatitis C virus infection (genotypes 1–6)","notes":"Evaluated in combination with simeprevir and AL-335 in two Phase 2 trials (N=365 and N=161) showing efficacy in treatment-naïve and treatment-experienced patients; development discontinued before Phase 3 initiation","phase":"Phase 2","status":"completed"}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02961660","phase":"PHASE1","title":"A Study to Evaluate the Effect of Severe Renal Impairment on the Single-dose Pharmacokinetics of Odalasvir","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2016-11-09","conditions":"Renal Insufficiency","enrollment":16},{"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},{"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},{"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},{"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},{"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},{"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},{"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},{"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}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"💊","route":"oral","frequency":"Data not available","formulation":"Tablet (25 mg strength); fixed-dose combination formulations with simeprevir and AL-335 were under development"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[{"notes":"Developed as part of Janssen's HCV DAA portfolio; program discontinued before regulatory approval","period":"Development–discontinued","companyName":"Janssen Research & Development, LLC","relationship":"Originator"}],"therapeuticAreas":["Infectious Disease"],"trialPhaseCounts":{"PHASE1":6,"PHASE2":3},"biosimilarFilings":[],"firstApprovalDate":"","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}}