Bamlanivimab

Overview

Bamlanivimab (LY-CoV555, also known as LY3819253), is a synthetic monoclonal antibody (mAb) derived from one of the first blood samples in the United States from a patient who recovered from COVID-19. Bamlanivimab is a neutralizing IgG1κ mAb directed against the SARS-CoV-2 spike (S) protein, which is described to block viral entry into human cells. AbCellera initially discovered bamlanivimab in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), and subsequently further developed it in collaboration with Eli Lilly and Company. Bamlanivimab consists of two identical light chains of 214 amino acids and two identical heavy chains of 455 amino acids each; the Fc region is unmodified. Bamlanivimab is produced in Chinese Hamster Ovary (CHO) cells. Based on phase 2 clinical trial (BLAZE-1) interim results, bamlanivimab was granted Emergency Use Authorization (EUA) by the FDA on November 10, 2020. It is set to enter phase 3 clinical trials. Under the EUA granted in February 2021, bamlanivimab is used in combination with etesevimab to treat mild to moderate COVID-19 in adults and pediatric patients who are at high risk for progressing to severe COVID-19: this EUA later expanded in December 2021 to include all younger children at high risk, including newborns. The EUA currently allows bamlanivimab and etesevimab for post-exposure prophylaxis of COVID-19 in adults and children.

Indication

Bamlanivimab is not currently approved for any indication by the FDA. Bamlanivimab is authorized under an Emergency Use Authorization (EUA) for the treatment of mild to moderate COVID-19 in patients aged 12 years and older weighing at least 40 kg who are at high risk for progressing to severe COVID-19 and/or hospitalization due to COVID-19. Patients should have confirmed COVID-19, with identification of SARS-CoV-2 viral load by an approved test. Under this EUA, bamlanivimab is not authorized in patients who are hospitalized due to COVID-19, who require oxygen due to COVID-19, or in patients on oxygen therapy for non-COVID-19-related comorbidity who require an increased oxygen flow rate due to COVID-19. Bamlanivimab in combination with etesevimab is used to treat mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients, including neonates, with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. This combination regimen is also used for post-exposure prophylaxis of COVID-19 in unvaccinated or immunocompromised adults and pediatric individuals, including neonates, who are at high risk of progression to severe COVID-19, including hospitalization or death.

Associated Conditions

Mild, moderate Novel Coronavirus Infectious Disease (COVID-19)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
COVID-19 and Disease Progression to the Severe Form: a Study on the Use of Monoclonal Antibodies Against SARS-CoV-2	2022/03/07	NCT05268601	N/A	Completed	University of Milano Bicocca
Non-inferiority Trial on Monoclonal Antibodies in COVID-19	2022/01/25	NCT05205759	Phase 3	Terminated	Azienda Ospedaliera Universitaria Integrata Verona
A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)	2021/01/08	NCT04701658	Phase 2	Completed	Eli Lilly and Company
At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19	2020/12/07	NCT04656691	Phase 4	Terminated	Daniel Griffin
A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness	2020/11/18	NCT04634409	Phase 2	Completed	Eli Lilly and Company
Expanded Access Program to Provide Bamlanivimab (LY3819253) for the Treatment of COVID-19	2020/10/27	NCT04603651	N/A	NO_LONGER_AVAILABLE	Eli Lilly and Company
A Study of LY3819253 (LY-CoV555) in Healthy Participants	2020/09/03	NCT04537910	Phase 1	Completed	Eli Lilly and Company
ACTIV-2: A Study for Outpatients With COVID-19	2020/08/19	NCT04518410	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
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	2020/08/04	NCT04497987	Phase 3	Completed	Eli Lilly and Company
A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness	2020/06/11	NCT04427501	Phase 2	Completed	Eli Lilly and Company

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Bamlanivimab	Eli Lilly and Company	0002-7910	INTRAVENOUS	35 mg in 1 mL	5/14/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
BAMLANIVIMAB	eli lilly canada inc	02508176	Solution - Intravenous	700 MG / 20 ML	12/24/2020

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

U.S. Monoclonal Antibodies Market Projected to Reach $284.9 Billion by 2034, Growing at 13.1% CAGR

7 months ago

The U.S. monoclonal antibodies market is expected to grow from $94.09 billion in 2025 to $284.90 billion by 2034, driven by rising prevalence of chronic diseases and expanding therapeutic applications beyond oncology.

FDA Grants Emergency Authorization to Lilly's Bebtelovimab for COVID-19, Securing $720M Government Contract

8 months ago

• The FDA has granted emergency use authorization to Eli Lilly's bebtelovimab for treating mild-to-moderate COVID-19 in high-risk patients aged 12 and older. • The US government has placed a $720 million order for up to 600,000 doses of bebtelovimab, with initial deliveries expected by March end. • Clinical data shows bebtelovimab retains full neutralizing activity against the Omicron variant and its subvariants, offering a crucial treatment option as other antibody therapies lose effectiveness.

FDA Restricts Sotrovimab Use Due to Omicron BA.2 Variant Resistance

3 years ago

• The FDA has suspended the authorization of GlaxoSmithKline and Vir Biotechnology's sotrovimab in regions where the Omicron BA.2 subvariant is dominant, citing inefficacy. • Sotrovimab, a monoclonal antibody, was previously authorized for treating high-risk COVID-19 patients but shows reduced effectiveness against the BA.2 subvariant. • Eli Lilly's bebtelovimab remains an authorized monoclonal antibody treatment, while oral antivirals also offer alternatives against BA.2. • GSK and Vir are preparing data on a higher dose of sotrovimab for the Omicron BA.2 subvariant for review by regulatory bodies.

FDA Revokes Emergency Use Authorization for Bamlanivimab Monotherapy Against COVID-19

4 years ago

The FDA revoked the EUA for bamlanivimab monotherapy due to increasing SARS-CoV-2 variants resistant to the treatment, raising the risk of treatment failure.

FDA Authorizes Eli Lilly's Bamlanivimab for Early-Stage COVID-19 Treatment

5 years ago

• The FDA granted emergency use authorization (EUA) to Eli Lilly's bamlanivimab (LY-CoV555) for treating mild-to-moderate COVID-19 in adults and pediatric patients. • Bamlanivimab, a monoclonal antibody, is authorized for patients with positive SARS-CoV-2 test results who are at high risk of progressing to severe COVID-19 or hospitalization. • The drug should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset, according to Eli Lilly. • Bamlanivimab is not authorized for patients hospitalized due to COVID-19, as studies suggest it may not be beneficial and could potentially worsen outcomes in these cases.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access