{"id":"bamlanivimab","rwe":[{"pmid":"41112342","year":"2025","title":"Effectiveness and Safety of Outpatient Monoclonal Antibody Use for the Treatment of COVID-19 in Children and Adolescents: Single Center Study.","finding":"","journal":"The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG","studyType":"Clinical Study"},{"pmid":"40434113","year":"2025","title":"The pan-variant potential of light: 425 nm light inactivates SARS-CoV-2 variants of concern and non-cytotoxic doses reduce viral titers in human airway epithelial cells.","finding":"","journal":"mSphere","studyType":"Clinical Study"},{"pmid":"40279347","year":"2025","title":"Effectiveness of Anti-SARS-CoV-2 monoclonal antibodies in real-life: RNAemia and clinical outcomes in high-risk COVID-19 patients.","finding":"","journal":"PloS one","studyType":"Clinical Study"},{"pmid":"39995815","year":"2025","title":"Monoclonal Antibodies in Prevention and Early Treatment of COVID-19 in Lung Transplant Recipients: A Systematic Review and Perspective on the Role of Monoclonal Antibodies in the Future.","finding":"","journal":"Transplant international : official journal of the European Society for Organ Transplantation","studyType":"Clinical Study"},{"pmid":"39832460","year":"2025","title":"Innate and SARS-CoV-2 specific adaptive immune response kinetic in neutralizing monoclonal antibody successfully treated COVID-19 patients.","finding":"","journal":"International immunopharmacology","studyType":"Clinical Study"}],"tags":[{"label":"Monoclonal Antibody","category":"modality"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"COVID-19","category":"indication"},{"label":"Eli Lilly and Company","category":"company"},{"label":"Approved 2020s","category":"decade"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antiviral Agents","category":"pharmacology"}],"phase":"discontinued","safety":{"safetySignals":[{"llr":1090.443,"date":"","count":595,"signal":"Infusion related reaction","source":"DrugCentral FAERS","actionTaken":"Reported 595 times (LLR=1090)"},{"llr":954.22,"date":"","count":283,"signal":"COVID-19 pneumonia","source":"DrugCentral FAERS","actionTaken":"Reported 283 times (LLR=954)"},{"llr":859.504,"date":"","count":399,"signal":"Oxygen saturation decreased","source":"DrugCentral FAERS","actionTaken":"Reported 399 times (LLR=860)"},{"llr":699.559,"date":"","count":712,"signal":"Dyspnoea","source":"DrugCentral FAERS","actionTaken":"Reported 712 times (LLR=700)"},{"llr":664.67,"date":"","count":301,"signal":"Hypoxia","source":"DrugCentral FAERS","actionTaken":"Reported 301 times (LLR=665)"},{"llr":437.475,"date":"","count":274,"signal":"Chills","source":"DrugCentral FAERS","actionTaken":"Reported 274 times (LLR=437)"},{"llr":318.807,"date":"","count":181,"signal":"Flushing","source":"DrugCentral FAERS","actionTaken":"Reported 181 times (LLR=319)"},{"llr":307.318,"date":"","count":416,"signal":"Pyrexia","source":"DrugCentral FAERS","actionTaken":"Reported 416 times (LLR=307)"},{"llr":256.179,"date":"","count":184,"signal":"Chest discomfort","source":"DrugCentral FAERS","actionTaken":"Reported 184 times (LLR=256)"},{"llr":183.397,"date":"","count":241,"signal":"Cough","source":"DrugCentral FAERS","actionTaken":"Reported 241 times (LLR=183)"},{"llr":152.601,"date":"","count":190,"signal":"Chest pain","source":"DrugCentral FAERS","actionTaken":"Reported 190 times (LLR=153)"},{"llr":134.303,"date":"","count":86,"signal":"Acute respiratory failure","source":"DrugCentral FAERS","actionTaken":"Reported 86 times (LLR=134)"},{"llr":124.573,"date":"","count":134,"signal":"Tachycardia","source":"DrugCentral FAERS","actionTaken":"Reported 134 times (LLR=125)"},{"llr":119.085,"date":"","count":132,"signal":"Respiratory failure","source":"DrugCentral FAERS","actionTaken":"Reported 132 times (LLR=119)"},{"llr":116.219,"date":"","count":43,"signal":"Fibrin D dimer increased","source":"DrugCentral FAERS","actionTaken":"Reported 43 times (LLR=116)"}],"commonSideEffects":[{"effect":"death","drugRate":"reported","severity":"serious"},{"effect":"life-threatening adverse event","drugRate":"reported","severity":"serious"},{"effect":"inpatient hospitalization or prolongation of existing hospitalization","drugRate":"reported","severity":"serious"},{"effect":"persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions","drugRate":"reported","severity":"serious"},{"effect":"congenital anomaly/birth defect","drugRate":"reported","severity":"serious"},{"effect":"medical or surgical intervention to prevent death, life-threatening event, hospitalization, disability, or congenital anomaly","drugRate":"reported","severity":"serious"}],"specialPopulations":{"Pregnancy":"There are insufficient data to evaluate drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bamlanivimab and etesevimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.","Geriatric use":"Of the 1141 patients receiving bamlanivimab and etesevimab in BLAZE-1, 30% were 65 years of age and older and 10% were 75 years of age and older. Based on population PK analyses, there is no difference in PK of bamlanivimab or etesevimab in geriatric patients compared to younger patients.","Paediatric use":"Bamlanivimab and etesevimab administered together are authorized for the treatment of mild to moderate COVID-19 and post-exposure prophylaxis for prevention of COVID-19 in pediatric patients, including neonates."}},"trials":[],"aliases":[],"company":"Eli Lilly and Company","patents":[],"pricing":[],"allNames":"ly-cov555","offLabel":[],"synonyms":["bamlanivimab","LY-CoV555","LY3819253"],"timeline":[{"date":"2020-11-11","type":"positive","source":"DrugCentral","milestone":"FDA approval (Eli Lilly and Company)"}],"aiSummary":"Ly-Cov555, also known as Bamlanivimab, is a monoclonal antibody treatment developed by Eli Lilly and Company. It was approved by the FDA in 2020 for the treatment of COVID-19. As a small molecule modality, its exact mechanism of action is not well understood, but it is believed to work by binding to the SARS-CoV-2 virus and preventing it from entering host cells. Ly-Cov555 is a patented treatment, and its commercial status is maintained by Eli Lilly and Company. Key safety considerations include potential allergic reactions and the risk of antibody-dependent enhancement.","brandName":"Ly-Cov555","ecosystem":[{"indication":"COVID-19","otherDrugs":[{"name":"casirivimab","slug":"casirivimab","company":"Regeneron Pharmaceuticals, Inc."},{"name":"etesevimab","slug":"etesevimab","company":"Eli Lilly and Company"},{"name":"imdevimab","slug":"imdevimab","company":"Regeneron Pharmaceuticals, Inc."},{"name":"nirmatrelvir","slug":"nirmatrelvir","company":"Pfizer, Inc."}],"globalPrevalence":null}],"mechanism":{"novelty":"Follow-on","modality":"Monoclonal Antibody","explanation":"Bamlanivimab is recombinant neutralizing human IgG1 monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. Bamlanivimab binds the spike protein with dissociation constant KD 0.071 nM and blocks spike protein attachment to the human ACE2 receptor with an IC50 value of 0.17 nM (0.025 ug/mL).Etesevimab is recombinant neutralizing human IgG1 mAb to the spike protein of SARS-CoV-2, with amino acid substitutions in the Fc region (L234A, L235A) to reduce effector function. Etesevimab binds the spike protein with dissociation constant KD 6.45 nM and blocks spike protein attachment to the human ACE2 receptor with an IC50 value of 0.32 nM (0.046 ug/mL).Bamlanivimab and etesevimab bind to different but overlapping epitopes in the receptor binding domain (RBD) of the S-protein. Using both antibodies together is expected to reduce the risk of viral resistance.","oneSentence":"Ly-Cov555 works by binding to the SARS-CoV-2 virus and preventing it from entering host cells.","technicalDetail":"Ly-Cov555 is a monoclonal antibody that targets the SARS-CoV-2 spike protein, preventing the virus from binding to and entering host cells through the angiotensin-converting enzyme 2 (ACE2) receptor."},"commercial":{"launchDate":"2020","_launchSource":"DrugCentral (FDA 2020-11-11, Eli Lilly and Company)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5453","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BAMLANIVIMAB","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BAMLANIVIMAB","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T08:57:02.182855","biosimilars":[],"competitors":[{"drugName":"casirivimab","drugSlug":"casirivimab","fdaApproval":"2020-11-21","relationship":"same-target"},{"drugName":"chloroquine","drugSlug":"chloroquine","fdaApproval":"1949-10-31","patentStatus":"Unknown","relationship":"same-target"},{"drugName":"clioquinol","drugSlug":"clioquinol","fdaApproval":"","relationship":"same-target"},{"drugName":"clofazimine","drugSlug":"clofazimine","fdaApproval":"1986-12-15","patentStatus":"Unknown","relationship":"same-target"},{"drugName":"etesevimab","drugSlug":"etesevimab","fdaApproval":"2020-11-09","relationship":"same-target"},{"drugName":"heparin","drugSlug":"heparin","fdaApproval":"1939-02-09","patentStatus":"Unknown","relationship":"same-target"},{"drugName":"imdevimab","drugSlug":"imdevimab","fdaApproval":"2020-11-21","relationship":"same-target"}],"genericName":"bamlanivimab","indications":{"approved":[{"name":"COVID-19","source":"DrugCentral","snomedId":840539006,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"casirivimab","brandName":"casirivimab","genericName":"casirivimab","approvalYear":"2020","relationship":"same-target"},{"drugId":"chloroquine","brandName":"chloroquine","genericName":"chloroquine","approvalYear":"1949","relationship":"same-target"},{"drugId":"clioquinol","brandName":"clioquinol","genericName":"clioquinol","approvalYear":"","relationship":"same-target"},{"drugId":"clofazimine","brandName":"clofazimine","genericName":"clofazimine","approvalYear":"1986","relationship":"same-target"},{"drugId":"etesevimab","brandName":"etesevimab","genericName":"etesevimab","approvalYear":"2020","relationship":"same-target"},{"drugId":"heparin","brandName":"heparin","genericName":"heparin","approvalYear":"1939","relationship":"same-target"},{"drugId":"imdevimab","brandName":"imdevimab","genericName":"imdevimab","approvalYear":"2020","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT04885452","phase":"","title":"Prevention of COVID-19 Complications in High-risk Subjects Infected by SARS-CoV-2 and Eligible for Treatment Under a Cohort ATU ('Autorisation Temporaire d'Utilisation') OR or Authorisation for Early Access (AAP). A Prospectvie Cohort.","status":"COMPLETED","sponsor":"ANRS, Emerging Infectious Diseases","startDate":"2021-09-21","conditions":["SARS-CoV Infection","Covid19"],"enrollment":756,"completionDate":"2023-12-18"},{"nctId":"NCT05268601","phase":"","title":"COVID-19 and Disease Progression to the Severe Form: a Study on the Use of Monoclonal Antibodies Against SARS-CoV-2","status":"COMPLETED","sponsor":"University of Milano Bicocca","startDate":"2021-10-14","conditions":["COVID-19"],"enrollment":251,"completionDate":"2023-12-22"},{"nctId":"NCT04790240","phase":"PHASE1,PHASE2","title":"Medical Herbs Inhibit Inflammation Directing T Cells to Kill the COVID-19 Virus (COVID)","status":"RECRUITING","sponsor":"All Natural Medicine Clinic, LLC","startDate":"2025-01-01","conditions":["Covid19 Virus Infection"],"enrollment":100,"completionDate":"2027-05-30"},{"nctId":"NCT04518410","phase":"PHASE2,PHASE3","title":"ACTIV-2: A Study for Outpatients With COVID-19","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2020-08-19","conditions":["Coronavirus","Covid19"],"enrollment":4044,"completionDate":"2023-06-20"},{"nctId":"NCT04427501","phase":"PHASE2,PHASE3","title":"A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2020-06-17","conditions":["COVID-19"],"enrollment":3307,"completionDate":"2023-02-21"},{"nctId":"NCT05780268","phase":"PHASE3","title":"LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2020-08-05","conditions":["COVID-19"],"enrollment":314,"completionDate":"2021-02-01"},{"nctId":"NCT04603651","phase":"","title":"Expanded Access Program to Provide Bamlanivimab (LY3819253) for the Treatment of COVID-19","status":"NO_LONGER_AVAILABLE","sponsor":"Eli Lilly and Company","startDate":"","conditions":["COVID-19"],"enrollment":0,"completionDate":""},{"nctId":"NCT04501978","phase":"PHASE3","title":"ACTIV-3: Therapeutics for Inpatients With COVID-19","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2020-08-04","conditions":["Covid19"],"enrollment":2753,"completionDate":"2023-07-14"},{"nctId":"NCT04790786","phase":"PHASE4","title":"UPMC OPTIMISE-C19 Trial, a COVID-19 Study","status":"TERMINATED","sponsor":"Erin McCreary","startDate":"2021-03-10","conditions":["Covid19"],"enrollment":4571,"completionDate":"2022-06-16"},{"nctId":"NCT04748588","phase":"PHASE4","title":"Treatment of Nosocomial COVID-19","status":"TERMINATED","sponsor":"University of Calgary","startDate":"2021-02-12","conditions":["Covid19","Nosocomial Infection","SARS-CoV2 Infection"],"enrollment":46,"completionDate":"2022-01-31"},{"nctId":"NCT05205759","phase":"PHASE3","title":"Non-inferiority Trial on Monoclonal Antibodies in COVID-19","status":"TERMINATED","sponsor":"Azienda Ospedaliera Universitaria Integrata Verona","startDate":"2021-12-09","conditions":["COVID-19"],"enrollment":319,"completionDate":"2022-04-05"},{"nctId":"NCT05439044","phase":"","title":"A Real-World Study of Anti-SARS-CoV-2 Monoclonal Antibodies","status":"UNKNOWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2020-03-01","conditions":["Immunocompromised Patients"],"enrollment":4000,"completionDate":"2022-12-31"},{"nctId":"NCT04634409","phase":"PHASE2","title":"A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2020-10-29","conditions":["COVID-19"],"enrollment":1755,"completionDate":"2021-10-18"},{"nctId":"NCT04840459","phase":"PHASE2","title":"Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting","status":"UNKNOWN","sponsor":"Sohail Rao","startDate":"2020-11-20","conditions":["Covid19"],"enrollment":1000,"completionDate":"2023-01-31"},{"nctId":"NCT04656691","phase":"PHASE4","title":"At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19","status":"TERMINATED","sponsor":"Daniel Griffin","startDate":"2021-01-04","conditions":["Covid19"],"enrollment":139,"completionDate":"2021-04-18"},{"nctId":"NCT04497987","phase":"PHASE3","title":"A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2020-08-02","conditions":["COVID-19","SARS-CoV2"],"enrollment":1180,"completionDate":"2021-05-20"},{"nctId":"NCT04537910","phase":"PHASE1","title":"A Study of LY3819253 (LY-CoV555) in Healthy 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