{"id":"odv-25-mg","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":[{"drug":"Simeprevir","action":"Monitor","effect":"Pharmacokinetic interaction studied; combined use evaluated in Phase 1 and Phase 2 trials"},{"drug":"AL-335","action":"Monitor","effect":"Pharmacokinetic interaction studied; combined use evaluated in Phase 1 and Phase 2 trials"}],"commonSideEffects":[],"contraindications":[],"specialPopulations":{"Pregnancy":"Data not available","Geriatric use":"Data not available","Paediatric use":"Data not available","Renal impairment":"Phase 1 study on renal impairment was withdrawn; no safety data available","Hepatic impairment":"Phase 1 study on hepatic impairment was withdrawn; no safety data available"},"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT03155893","NCT03277755"],"aliases":["JNJ-64289901"],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2013","type":"neutral","milestone":"Phase 1 pharmacokinetic interaction study initiated","regulator":"none","description":"Early-stage evaluation of odalasvir alone and in combination with other antivirals in healthy volunteers."},{"date":"2014","type":"positive","milestone":"Phase 1 cardiac safety study completed","regulator":"none","description":"Study of AL-335 on background of simeprevir and odalasvir in 59 healthy subjects demonstrated acceptable cardiac safety profile."},{"date":"2014","type":"positive","milestone":"Phase 2 efficacy and safety trial completed (N=365)","regulator":"none","description":"Efficacy and safety of AL-335, odalasvir, and simeprevir combination in chronic hepatitis C patients completed by Janssen."},{"date":"2015","type":"positive","milestone":"Phase 2 Japanese population study completed (N=33)","regulator":"none","description":"Safety, pharmacokinetics, and efficacy of AL-335/odalasvir/simeprevir combination in Japanese patients with chronic hepatitis C."},{"date":"2015","type":"positive","milestone":"Phase 2 Alios-sponsored trial completed (N=161)","regulator":"none","description":"Safety, pharmacokinetics, and efficacy evaluation of AL-335/odalasvir combination in chronic hepatitis C patients."},{"date":"2016","type":"negative","milestone":"Development program discontinued","regulator":"none","description":"Janssen discontinued odalasvir development before Phase 3 initiation or regulatory submission, likely due to competitive landscape dominated by superior all-oral regimens (sofosbuvir/velpatasvir, glecaprevir/pibrentasvir)."}],"aiSummary":"ODV 25 mg (odalasvir) is a hepatitis C virus NS5A inhibitor developed by Janssen Research & Development that was discontinued before FDA approval. The drug was designed to inhibit the NS5A protein, a critical regulator of HCV replication and virion assembly, and was evaluated in combination with other direct-acting antivirals (simeprevir and AL-335) in Phase 2 clinical trials enrolling 559 patients with chronic hepatitis C. Clinical development was halted despite completion of Phase 2 efficacy and safety studies, likely due to competitive pressures from other all-oral HCV regimens that achieved superior efficacy profiles or simpler dosing schedules. The discontinuation reflects the rapidly evolving HCV treatment landscape where multiple first-in-class and best-in-class combination therapies achieved market dominance, reducing commercial viability for late-stage entrants. No approved indications, revenue, or commercial data exist for this discontinued asset.","brandName":"ODV 25 mg","companyId":"janssen-research-development-llc","ecosystem":[],"mechanism":{"target":"Hepatitis C virus NS5A protein","novelty":"best-in-class","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 (HCV). The NS5A protein is a multifunctional regulator essential for HCV RNA replication and the assembly and secretion of infectious viral particles. By binding to and inhibiting NS5A, odalasvir disrupts both the early replication phase and the later stages of virion production, effectively suppressing viral load in infected patients. The drug was designed to be used as part of combination therapy with other DAAs (such as simeprevir, a protease inhibitor, and AL-335, a nucleotide polymerase inhibitor) to achieve high barrier to resistance and improved efficacy across diverse HCV genotypes.","oneSentence":"Odalasvir inhibits hepatitis C virus NS5A protein to block viral replication and assembly.","technicalDetail":"Odalasvir is a small-molecule NS5A inhibitor with potent in vitro activity against HCV genotypes 1–6. The compound binds to the N-terminal domain of NS5A, disrupting its zinc finger structure and preventing RNA binding and replication complex formation. Pharmacokinetically, odalasvir exhibits moderate oral bioavailability and is metabolized hepatically; Phase 1 studies demonstrated dose-proportional PK with a half-life suitable for once-daily dosing. The drug shows synergistic antiviral activity when combined with NS3/4A protease inhibitors and nucleotide polymerase inhibitors, supporting its use in all-oral, interferon-free regimens."},"commercial":{"notes":"Drug was discontinued before FDA approval; no commercial launch or revenue 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 all-oral, pan-genotypic HCV regimen with superior efficacy and simpler dosing; established market dominance by time of ODV Phase 2 completion"},{"name":"Glecaprevir/Pibrentasvir","slug":"glecaprevir-pibrentasvir","company":"AbbVie","advantage":"Pan-genotypic, single-tablet regimen with 8-week treatment duration and >99% cure rates; approved during ODV development phase"},{"name":"Sofosbuvir/Velpatasvir/Voxilaprevir","slug":"sofosbuvir-velpatasvir-voxilaprevir","company":"Gilead Sciences","advantage":"Triple-agent all-oral regimen for treatment-experienced patients; approved before ODV Phase 3 initiation"}],"genericName":"ODV 25 mg","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Chronic Hepatitis C (genotypes 1–6)","notes":"Evaluated in combination with simeprevir and AL-335 in three Phase 2 trials (N=559 total); trials completed but development discontinued before Phase 3 initiation or regulatory submission.","phase":"Phase 2","status":"completed"}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"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":"NCT02058693","phase":"PHASE4","title":"Adjunctive Mixed Salts Amphetamine for Depressed Adults With Incomplete Response to Current Antidepressant Therapy","status":"COMPLETED","sponsor":"Rush University Medical Center","startDate":"2010-12","conditions":"Major Depressive Disorder","enrollment":41},{"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":"NCT01372150","phase":"PHASE3","title":"A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD","status":"COMPLETED","sponsor":"Pfizer","startDate":"2011-11-17","conditions":"Major Depressive Disorder","enrollment":340},{"nctId":"NCT00831415","phase":"PHASE3","title":"Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2009-03","conditions":"Major Depressive Disorder","enrollment":304},{"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":"NCT01371708","phase":"PHASE3","title":"A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD","status":"COMPLETED","sponsor":"Pfizer","startDate":"2012-02-02","conditions":"Major Depressive Disorder","enrollment":283},{"nctId":"NCT01371734","phase":"PHASE3","title":"A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD","status":"COMPLETED","sponsor":"Pfizer","startDate":"2011-08","conditions":"Major Depressive Disorder","enrollment":363},{"nctId":"NCT01371721","phase":"PHASE3","title":"A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD","status":"COMPLETED","sponsor":"Pfizer","startDate":"2012-02","conditions":"Major Depressive Disorder","enrollment":269},{"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},{"nctId":"NCT02054299","phase":"PHASE1","title":"Open Label Pharmacokinetic-Pharmacogenetic Study on Polymorphisms in the Organic Cation Transporter OCT1","status":"COMPLETED","sponsor":"University Medical Center Goettingen","startDate":"2013-04","conditions":"Drug Metabolism, Membrane Transport","enrollment":48},{"nctId":"NCT00887224","phase":"PHASE3","title":"Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder","status":"COMPLETED","sponsor":"Pfizer","startDate":"2009-06","conditions":"Major Depressive Disorder","enrollment":874},{"nctId":"NCT01056289","phase":"PHASE4","title":"Study Comparing Discontinuation Symptoms Of DVS SR In Subjects With Major Depressive Disorder (MDD)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2010-03","conditions":"Major Depressive Disorder","enrollment":480},{"nctId":"NCT01190514","phase":"PHASE1","title":"Phase 1 Study To Test the Bioequivalence Between Two 25 mg Tablets vs. One 50 mg Tablet Under Fast/Fed Condition and Evaluate Food Effect of Desvenlafaxine Succinate Sustained Release (DVS SR)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2010-09","conditions":"Depression - Major Depressive Disorder","enrollment":41},{"nctId":"NCT00401245","phase":"PHASE3","title":"The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms","status":"COMPLETED","sponsor":"Pfizer","startDate":"2006-12","conditions":"Vasomotor Symptoms","enrollment":500},{"nctId":"NCT00683800","phase":"PHASE3","title":"Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women","status":"COMPLETED","sponsor":"Pfizer","startDate":"2008-06","conditions":"Vasomotor Symptoms","enrollment":2186}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"💊","route":"oral","frequency":"Data not available","formulation":"Tablet (25 mg strength)"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[{"notes":"Developed as part of Janssen's HCV DAA portfolio; program discontinued before commercialization","period":"2010–present","companyName":"Janssen Research & Development, LLC (Johnson & Johnson subsidiary)","relationship":"Originator"}],"therapeuticAreas":["Infectious Disease"],"trialPhaseCounts":{"PHASE1":8,"PHASE2":3,"PHASE3":9,"PHASE4":2},"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":2,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}