{"id":"daclatasvir","rwe":[{"pmid":"41850218","year":"2026","title":"The effect of HFE gene mutation and iron overload on sustained virological response in Egyptian chronic hepatitis C patients treated with daclatasvir and sofosbuvir.","finding":"","journal":"The Korean journal of internal medicine","studyType":"Clinical Study"},{"pmid":"41781841","year":"2026","title":"Efficacy of Sofosbuvir and Daclatasvir Combination Treatment in Haemodialysis Patients with Chronic Hepatitis C.","finding":"","journal":"Journal of the College of Physicians and Surgeons--Pakistan : JCPSP","studyType":"Clinical Study"},{"pmid":"41706727","year":"2026","title":"Repurposing antiviral agents against mucormycosis.","finding":"","journal":"PloS one","studyType":"Clinical Study"},{"pmid":"41626039","year":"2026","title":"A Decade Long, Real-life Experience of Sofosbuvir-based Regimen Use for Hepatitis C Treatment in People With End-stage Renal Disease.","finding":"","journal":"Journal of clinical and experimental hepatology","studyType":"Clinical Study"},{"pmid":"41527035","year":"2026","title":"Chronic blood-borne viral hepatitis in a tertiary hospital in Al-Baha, Saudi Arabia: epidemiology, liver enzyme correlations, and treatment outcomes.","finding":"","journal":"BMC infectious diseases","studyType":"Clinical Study"}],"tags":[{"label":"Hepatitis C Virus NS5A Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Potassium voltage-gated channel subfamily H member 2","category":"target"},{"label":"KCNH2","category":"gene"},{"label":"J05AP07","category":"atc"},{"label":"LOE Approaching","category":"status"},{"label":"Chronic hepatitis C","category":"indication"},{"label":"Bristol-Myers Squibb","category":"company"},{"label":"Approved 2010s","category":"decade"}],"phase":"marketed","safety":{"safetySignals":[{"llr":1830.207,"date":"","count":388,"signal":"Hepatocellular carcinoma","source":"DrugCentral FAERS","actionTaken":"Reported 388 times (LLR=1830)"},{"llr":976.049,"date":"","count":251,"signal":"Hepatitis C","source":"DrugCentral FAERS","actionTaken":"Reported 251 times (LLR=976)"},{"llr":849.941,"date":"","count":154,"signal":"Genotype drug resistance test positive","source":"DrugCentral FAERS","actionTaken":"Reported 154 times (LLR=850)"},{"llr":440.362,"date":"","count":117,"signal":"Viral mutation identified","source":"DrugCentral FAERS","actionTaken":"Reported 117 times (LLR=440)"},{"llr":409.285,"date":"","count":120,"signal":"Virologic failure","source":"DrugCentral FAERS","actionTaken":"Reported 120 times (LLR=409)"},{"llr":393.227,"date":"","count":141,"signal":"Hepatic encephalopathy","source":"DrugCentral FAERS","actionTaken":"Reported 141 times (LLR=393)"},{"llr":384.113,"date":"","count":294,"signal":"Treatment failure","source":"DrugCentral FAERS","actionTaken":"Reported 294 times (LLR=384)"},{"llr":361.166,"date":"","count":190,"signal":"Ascites","source":"DrugCentral FAERS","actionTaken":"Reported 190 times (LLR=361)"},{"llr":345.66,"date":"","count":171,"signal":"Hepatic failure","source":"DrugCentral FAERS","actionTaken":"Reported 171 times (LLR=346)"},{"llr":284.865,"date":"","count":75,"signal":"Liver transplant","source":"DrugCentral FAERS","actionTaken":"Reported 75 times (LLR=285)"},{"llr":217.651,"date":"","count":68,"signal":"Hepatitis B reactivation","source":"DrugCentral FAERS","actionTaken":"Reported 68 times (LLR=218)"},{"llr":190.927,"date":"","count":97,"signal":"Hepatic cirrhosis","source":"DrugCentral FAERS","actionTaken":"Reported 97 times (LLR=191)"},{"llr":162.89,"date":"","count":78,"signal":"Hyperbilirubinaemia","source":"DrugCentral FAERS","actionTaken":"Reported 78 times (LLR=163)"},{"llr":147.353,"date":"","count":320,"signal":"Headache","source":"DrugCentral FAERS","actionTaken":"Reported 320 times (LLR=147)"},{"llr":146.019,"date":"","count":33,"signal":"Cryoglobulinaemia","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=146)"}],"commonSideEffects":[]},"trials":[],"aliases":[],"company":"Bristol-Myers Squibb","patents":[{"applNo":"N206843","source":"FDA Orange Book","status":"Active","expires":"Aug 8, 2027","useCode":"U-1725","territory":"US","drugProduct":false,"patentNumber":"8900566","drugSubstance":false},{"applNo":"N206843","source":"FDA Orange Book","status":"Active","expires":"Aug 11, 2027","useCode":"U-1724","territory":"US","drugProduct":true,"patentNumber":"8642025","drugSubstance":true},{"applNo":"N206843","source":"FDA Orange Book","status":"Active","expires":"Aug 8, 2027","useCode":"U-1725","territory":"US","drugProduct":false,"patentNumber":"9421192","drugSubstance":true},{"applNo":"N206843","source":"FDA Orange Book","status":"Active","expires":"Jun 13, 2031","useCode":"U-1724","territory":"US","drugProduct":true,"patentNumber":"8629171","drugSubstance":true},{"applNo":"N206843","source":"FDA Orange Book","status":"Active","expires":"Jul 24, 2029","useCode":"","territory":"US","drugProduct":false,"patentNumber":"8329159","drugSubstance":true}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DACLATASVIR","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:27:07.470884+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T03:27:07.470791+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Daclatasvir","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:27:15.395599+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:27:13.943553+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T03:27:07.545008+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DACLATASVIR","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:27:14.185856+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Nonstructural protein 5A inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:27:15.395536+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2303621/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:27:15.040381+00:00"}},"allNames":"daklinza","offLabel":[],"synonyms":["daclatasvir","daclatasvir dihydrochloride","daclatasvir hydrochloride","daklinza","BMS-790052-05","BMS-790052","daclatasvir HCl","daclatasivr"],"timeline":[{"date":"2014-06-27","type":"positive","source":"DrugCentral","milestone":"EMA approval"},{"date":"2015-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from BRISTOL MYERS SQUIBB to Bristol-Myers Squibb"},{"date":"2015-07-24","type":"positive","source":"DrugCentral","milestone":"FDA approval (Bristol Myers Squibb)"},{"date":"2027-08-08","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 9421192 expires"},{"date":"2029-07-24","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 8329159 expires"},{"date":"2031-06-13","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 8629171 expires"}],"aiSummary":"Daklinza (DACLATASVIR) is a small molecule Hepatitis C Virus NS5A Inhibitor developed by Bristol-Myers Squibb. It targets the potassium voltage-gated channel subfamily H member 2 and is used to treat chronic hepatitis C. Daklinza was FDA approved in 2015 and is still commercially available under patent. Key safety considerations include its potential interactions with other medications and the need for monitoring of liver function. Daklinza is not yet available as a generic medication.","approvals":[{"date":"2014-06-27","orphan":false,"company":"","regulator":"EMA"},{"date":"2015-07-24","orphan":false,"company":"BRISTOL MYERS SQUIBB","regulator":"FDA"}],"brandName":"Daklinza","ecosystem":[{"indication":"Chronic hepatitis C","otherDrugs":[{"name":"boceprevir","slug":"boceprevir","company":"Merck Sharp Dohme"},{"name":"dasabuvir","slug":"dasabuvir","company":"Abbvie Inc"},{"name":"elbasvir","slug":"elbasvir","company":"Merck Sharp Dohme"},{"name":"glecaprevir","slug":"glecaprevir","company":"Abbvie Inc"}],"globalPrevalence":58000000}],"mechanism":{"target":"Potassium voltage-gated channel subfamily H member 2","novelty":"Follow-on","targets":[{"gene":"KCNH2","source":"DrugCentral","target":"Potassium voltage-gated channel subfamily H member 2","protein":"Potassium voltage-gated channel subfamily H member 2"}],"moaClass":"Breast Cancer Resistance Protein Inhibitors","modality":"Small Molecule","drugClass":"Hepatitis C Virus NS5A Inhibitor","explanation":"","oneSentence":"","technicalDetail":"Daklinza (DACLATASVIR) is a potent inhibitor of the NS5A protein, which is essential for the replication and survival of the Hepatitis C virus. By binding to the NS5A protein, Daklinza prevents the virus from replicating and reduces viral load, allowing the body's immune system to clear the infection."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Daclatasvir","title":"Daclatasvir","extract":"Daclatasvir, sold under the brand name Daklinza, is an antiviral medication used in combination with other medications to treat hepatitis C (HCV). The other medications used in combination include sofosbuvir, ribavirin, and interferon, vary depending on the virus type and whether the person has cirrhosis. It is taken by mouth.","wiki_history":"==History==\n\n\nDaklinza was discovered by scientists at Bristol-Myers Squibb (BMS); the precursor was identified using phenotypic screening in which the GT-1b replicon system was implemented in Huh7 cells and bovine viral diarrhea virus also in Huh7 cells was used as a counterscreen for specificity. Bristol Myers Squibb also developed the drug, with the first Phase I trial publishing in 2010.\n\nIt was approved for use in Europe in August 2014, in the US in July 2015, and in India in December 2015; it was first in the class of NS5A inhibitors to reach the market.","wiki_society_and_culture":"==Society and culture==\nIt is on the World Health Organization's List of Essential Medicines.\n\nAs of January 2016, a twelve-week course cost around $63,000 in the US, around $39,000 in the UK, around $37,000 in France, and $525 in Egypt."},"commercial":{"launchDate":"2015","_launchSource":"DrugCentral (FDA 2015-07-24, BRISTOL MYERS SQUIBB)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4875","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=DACLATASVIR","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DACLATASVIR","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Daclatasvir","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T10:23:16.568978","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:27:16.624154+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"ribavirin","drugSlug":"ribavirin","fdaApproval":"1985-12-31","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"telaprevir","drugSlug":"telaprevir","fdaApproval":"2011-05-23","patentExpiry":"May 30, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"boceprevir","drugSlug":"boceprevir","fdaApproval":"2011-05-13","patentExpiry":"Nov 11, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"simeprevir","drugSlug":"simeprevir","fdaApproval":"2013-11-22","patentExpiry":"Sep 5, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"sofosbuvir","drugSlug":"sofosbuvir","fdaApproval":"2013-12-06","patentExpiry":"Sep 26, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"dasabuvir","drugSlug":"dasabuvir","fdaApproval":"2014-12-19","relationship":"same-class"},{"drugName":"elbasvir","drugSlug":"elbasvir","fdaApproval":"2016-01-28","relationship":"same-class"},{"drugName":"grazoprevir","drugSlug":"grazoprevir","fdaApproval":"2016-01-28","relationship":"same-class"},{"drugName":"ledipasvir","drugSlug":"ledipasvir","fdaApproval":"2014-10-10","relationship":"same-class"},{"drugName":"ombitasvir","drugSlug":"ombitasvir","fdaApproval":"2014-12-19","relationship":"same-class"},{"drugName":"paritaprevir","drugSlug":"paritaprevir","fdaApproval":"2014-12-19","relationship":"same-class"},{"drugName":"ritonavir","drugSlug":"ritonavir","fdaApproval":"1996-03-01","genericCount":6,"patentStatus":"Off-patent — generic 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Squibb","drugCategory":"loe-approaching","labelChanges":[],"relatedDrugs":[{"drugId":"ribavirin","brandName":"ribavirin","genericName":"ribavirin","approvalYear":"1985","relationship":"same-class"},{"drugId":"telaprevir","brandName":"telaprevir","genericName":"telaprevir","approvalYear":"2011","relationship":"same-class"},{"drugId":"boceprevir","brandName":"boceprevir","genericName":"boceprevir","approvalYear":"2011","relationship":"same-class"},{"drugId":"simeprevir","brandName":"simeprevir","genericName":"simeprevir","approvalYear":"2013","relationship":"same-class"},{"drugId":"sofosbuvir","brandName":"sofosbuvir","genericName":"sofosbuvir","approvalYear":"2013","relationship":"same-class"},{"drugId":"dasabuvir","brandName":"dasabuvir","genericName":"dasabuvir","approvalYear":"2014","relationship":"same-class"},{"drugId":"elbasvir","brandName":"elbasvir","genericName":"elbasvir","approvalYear":"2016","relationship":"same-class"},{"drugId":"grazoprevir","brandName":"grazoprevir","genericName":"grazoprevir","approvalYear":"2016","relationship":"same-class"},{"drugId":"ledipasvir","brandName":"ledipasvir","genericName":"ledipasvir","approvalYear":"2014","relationship":"same-class"},{"drugId":"ombitasvir","brandName":"ombitasvir","genericName":"ombitasvir","approvalYear":"2014","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT05992077","phase":"NA","title":"Study 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Infection"],"enrollment":1609,"completionDate":"2021-12-31"},{"nctId":"NCT02992457","phase":"PHASE4","title":"Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection","status":"COMPLETED","sponsor":"Tanta University","startDate":"2015-01","conditions":["Hepatitis C"],"enrollment":10000,"completionDate":"2019-12"},{"nctId":"NCT03612973","phase":"NA","title":"Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy","status":"COMPLETED","sponsor":"Assiut University","startDate":"2019-06-01","conditions":["Chronic Hepatitis c"],"enrollment":80,"completionDate":"2022-09-30"},{"nctId":"NCT01866930","phase":"PHASE3","title":"Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV","status":"TERMINATED","sponsor":"Bristol-Myers 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