Drugs / Bamlanivimab
Bamlanivimab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Bamlanivimab and etesevimab for COVID-19 | — | 2021-10-29 | europa.eu ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04537910 | Sep → Dec 2020 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04411628 | May → Aug 2020 | COVID-19 | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04701658 | Feb → Jun 2021 | COVID-19 | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT04840459 | Nov 2020 → Dec 2022 | COVID-19 | Sohail Rao | Unknown | No outcome recorded |
| Phase 2 | NCT04634409 | Oct 2020 → Jul 2021 | COVID-19 | Eli Lilly and Company | Completed | Mixed |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT04518410 | Aug 2020 → Apr 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/3 | NCT04427501 | Jun 2020 → Feb 2023 | COVID-19 | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 34 trials · 1 met primary · 2 missed | ||||||
| Phase 3 | NCT05205759 | Dec 2021 → Feb 2022 | COVID-19 | Azienda Ospedaliera Universitaria Integrata Verona | Terminated | No outcome recorded |
| Phase 3 | NCT05780268 | Aug 2020 → Feb 2021 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 3 | NCT04501978 | Aug 2020 → Apr 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 3 | NCT04497987 | Aug 2020 → Jan 2021 | COVID-19 | Eli Lilly and Company | Completed | Met primary |
| Phase 44 trials · 1 missed | ||||||
| Phase 4 | NCT04796402 | Mar → Jun 2021 | COVID-19 | Fraser Health | Unknown | No outcome recorded |
| Phase 4 | NCT04790786 | Mar 2021 → Jun 2022 | COVID-19 | Erin McCreary | Terminated | Missed primary |
| Phase 4 | NCT04748588 | Feb 2021 → Jan 2022 | COVID-19, nosocomial infection | University of Calgary | Terminated | No outcome recorded |
| Phase 4 | NCT04656691 | Jan → Apr 2021 | COVID-19 | Daniel Griffin | Terminated | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04603651 | — | COVID-19 | Eli Lilly and Company | No longer available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT04790240 Comparator | Jan 2025 → Dec 2026 expected | COVID-19 | All Natural Medicine Clinic, LLC | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 30
| Date | Issuer | Release |
|---|---|---|
| 2021-12-03 | AbCellera Biologics Inc. | Regulatory AbCellera-Discovered Bamlanivimab Together with Etesevimab Authorized as the First and Only Antibody Therapy for Emergency Use in COVID-19 Patients Under the Age of 12 abcellera.com ↗
AbCellera (Nasdaq: ABCL) today announced the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab administered together to include pediatric patients under the age of 12, including neonates (infants <1 year old). |
| 2021-12-03 | Eli Lilly and Company | Regulatory Lilly's bamlanivimab with etesevimab authorized as the first and only neutralizing antibody therapy for emergency use in COVID-19 patients under the age of 12 lilly.com ↗
The U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab administered together to include certain high-risk pediatric patients from birth to <12 years old, Eli Lilly and Company (NYSE: LLY) announced today. |
| 2021-09-16 | AbCellera Biologics Inc. | Regulatory Emergency Use Authorization of AbCellera-Discovered Bamlanivimab Administered with Etesevimab Expanded by the FDA to Include Post-Exposure Prophylaxis for the Prevention of COVID-19 abcellera.com ↗
AbCellera (Nasdaq: ABCL) today announced the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg administered with etesevimab (LY-CoV016) 1400 mg to include post-exposure prophylaxis (PEP) to prevent SARS-CoV-2 infection or symptomatic COVID-19. |
| 2021-09-16 | Eli Lilly and Company | Regulatory Emergency Use Authorization for Lilly's bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19 lilly.com ↗
This authorization follows the national reopening of distribution earlier this month. |
| 2021-05-26 | GlaxoSmithKline | Results GSK and Vir Biotechnology announce sotrovimab (VIR-7831) receives Emergency Use Authorization from the US FDA for treatment of mild-to-moderate COVID-19 in high-risk adults and paediatric patients gsk.com ↗
An interim analysis found that bamlanivimab (700 mg) co-administered with sotrovimab (500 mg) demonstrated a 70% relative reduction in patients with persistently high viral load at day 7 compared to placebo, meeting the primary endpoint. |
| 2021-05-21 | Vir Biotechnology, Inc. | Results CORRECTION -- EMA Issues Positive Scientific Opinion on GSK and Vir Biotechnology’s Sotrovimab For the Early Treatment of COVID-19 vir.bio ↗
An interim analysis found that bamlanivimab (700 mg) co-administered with sotrovimab (500 mg) demonstrated a 70% relative reduction of patients with persistently high viral load at day 7 compared to placebo, meeting the primary endpoint. |
| 2021-04-16 | Eli Lilly and Company | Regulatory Lilly requests revocation of emergency use authorization for bamlanivimab alone to complete transition to bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S. lilly.com ↗
Eli Lilly and Company (NYSE: LLY) has requested the U.S. Food and Drug Administration (FDA) revoke the Emergency Use Authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg alone. |
| 2021-04-05 | AbCellera Biologics Inc. | Results Published Peer-Reviewed Data Demonstrate Bamlanivimab’s High Potency Against SARS-CoV-2 and Support its Use as a Foundational Antibody Therapy to Treat and Prevent COVID-19 abcellera.com ↗
Bamlanivimab (LY-CoV555) has greater affinity and potency relative to other RBD-binding and ACE2-blocking antibodies tested in this study |
| 2021-03-29 | GlaxoSmithKline | Results Lilly, Vir Biotechnology and GSK announce positive topline data from the phase 2 BLAZE-4 trial evaluating bamlanivimab with VIR-7831 in low-risk adults with COVID-19 gsk.com ↗
In combination, the two monoclonal antibodies demonstrated a 70% relative reduction in persistently high viral load at day 7 compared to placebo. |
| 2021-03-29 | Vir Biotechnology, Inc. | Results Lilly, Vir Biotechnology and GSK Announce Positive Topline Data from the Phase 2 BLAZE-4 Trial Evaluating Bamlanivimab with VIR-7831 in Low-Risk Adults with COVID-19 vir.bio ↗
In combination, the two monoclonal antibodies demonstrated a 70% relative reduction in persistently high viral load at day 7 compared to placebo |
| 2021-03-29 | Eli Lilly and Company | Results Lilly, Vir Biotechnology and GSK Announce Positive Topline Data from the Phase 2 BLAZE-4 Trial Evaluating Bamlanivimab with VIR-7831 in Low-Risk Adults with COVID-19 lilly.com ↗
In addition, bamlanivimab administered with VIR-7831 demonstrated a statistically significant reduction compared to placebo in the key virologic secondary endpoints of mean change from baseline to days 3, 5 and 7 in SARS-CoV-2 viral load. |
| 2021-03-10 | AbCellera Biologics Inc. | Results AbCellera-Discovered Bamlanivimab Together with Etesevimab Reduced Hospitalizations and Prevented Death in Phase 3 Trial for Early COVID-19 abcellera.com ↗
Patients who received bamlanivimab and etesevimab together had an 87% reduction in hospitalizations and death; no patients died who received the therapy |
| 2021-03-10 | Eli Lilly and Company | Results Lilly's bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19 lilly.com ↗
There were four events in patients taking bamlanivimab with etesevimab and 15 events in patients taking placebo, representing an 87 percent risk reduction (p<0.0001). |
| 2021-03-05 | AbCellera Biologics Inc. | Regulatory EMA Advises Use of AbCellera-Discovered Bamlanivimab, Alone or Together with Etesevimab, to Treat Confirmed COVID-19 Patients abcellera.com ↗
AbCellera (Nasdaq: ABCL) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab. |
| 2021-03-05 | Eli Lilly and Company | Regulatory EMA issues advice on Lilly's bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab. |
| 2021-02-09 | AbCellera Biologics Inc. | Regulatory AbCellera-Discovered Antibody, Bamlanivimab, Administered with Etesevimab Receives FDA Emergency Use Authorization for COVID-19 abcellera.com ↗ |
| 2021-02-09 | Eli Lilly and Company | Regulatory Lilly's bamlanivimab (LY-CoV555) administered with etesevimab (LY-CoV016) receives FDA emergency use authorization for COVID-19 lilly.com ↗
The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for investigational bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together, Eli Lilly and Company (NYSE: LLY) announced today. |
| 2021-02-01 | Vir Biotechnology, Inc. | Results Vir Biotechnology Announces New Data Highlighting the Importance of Targeting Conserved Regions of the SARS-CoV-2 Spike Protein in the Development of Therapeutics vir.bio ↗
When tested across four clinical-stage antibodies – S309 (the precursor of VIR-7831), LY-CoV555, REGN10933 and REGN10987 – S309, which targets a non-RBM epitope, LY-CoV555 and REGN10933 were capable of neutralizing the N439K variant. |
| 2021-01-26 | AbCellera Biologics Inc. | Results AbCellera-Discovered Antibody, Bamlanivimab, Administered with Etesevimab Reduced Risk of COVID-19 Hospitalizations and Death by 70% abcellera.com ↗
Bamlanivimab and etesevimab together reduced COVID-19 events by 70% versus placebo (p=0.0004); |
| 2021-01-26 | Eli Lilly and Company | Results New data show treatment with Lilly's neutralizing antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) together reduced risk of COVID-19 hospitalizations and death by 70 percent lilly.com ↗
Bamlanivimab and etesevimab together also demonstrated statistically significant improvements on all key secondary endpoints, providing strong evidence that the therapy reduced viral load and accelerated symptom resolution. |
| 2021-01-21 | AbCellera Biologics Inc. | Results AbCellera-Discovered Antibody Prevented COVID-19 in Nursing Homes and Reduced Risks by up to 80% for Residents abcellera.com ↗
Bamlanivimab reduced the risk of contracting COVID-19 by up to 80% in residents versus placebo (odds ratio 0.20; p=0.00026); |
| 2021-01-21 | Eli Lilly and Company | Results Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 percent for residents lilly.com ↗
Bamlanivimab (LY-CoV555) significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities, Eli Lilly and Company (NYSE: LLY) announced. |
| 2020-11-20 | AbCellera Biologics Inc. | Regulatory AbCellera-Discovered Antibody Granted Interim Authorization by Health Canada as a Treatment for COVID-19 abcellera.com ↗
Bamlanivimab is authorized for treatment of recently diagnosed, mild to moderate COVID-19 in high-risk patients |
| 2020-11-20 | Eli Lilly and Company | Regulatory Lilly's neutralizing antibody bamlanivimab (LY-CoV555) receives interim authorization from Health Canada as a treatment for COVID-19 lilly.com ↗
This authorization, the second authorization around the world for bamlanivimab, is based on data from BLAZE-1, a randomized, double-blind placebo-controlled phase 2 study in patients with recently diagnosed, mild to moderate COVID-19. |
| 2020-11-09 | Eli Lilly and Company | Regulatory Lilly's neutralizing antibody bamlanivimab (LY-CoV555) receives FDA emergency use authorization for the treatment of recently diagnosed COVID-19 lilly.com ↗
The U.S. Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for Eli Lilly and Company's (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. |
| 2020-11-06 | Vir Biotechnology, Inc. | Results Vir Biotechnology Publishes New Research Characterizing Variation in the SARS-CoV-2 Spike Protein and Virulence of a Prevalent Immune Evasion Variant, N439K vir.bio ↗
When tested across four clinical-stage antibodies – S309 (the precursor of VIR-7831), LY-CoV555, REGN10933 and REGN10987 – S309, which targets a non-RBM epitope, LY-CoV555 and REGN10933 were capable of neutralizing the N439K variant. |
| 2020-10-28 | Eli Lilly and Company | Results Data for Lilly's bamlanivimab (LY-CoV555) in COVID-19 outpatients published in New England Journal of Medicine lilly.com ↗
These data show bamlanivimab may be effective in treating COVID-19 by reducing viral load, symptoms and the risk of hospitalization in outpatients. |
| 2020-10-07 | Eli Lilly and Company | Results Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs lilly.com ↗
Data from a new interim analysis of the BLAZE-1 clinical trial showed that combination therapy with two of Lilly's SARS-CoV-2 neutralizing antibodies reduced viral load, symptoms and COVID-related hospitalization and ER visits. |
| 2020-09-16 | AbCellera Biologics Inc. | Results Interim Data Reported for AbCellera-Discovered COVID-19 Antibody in Phase 2 Clinical Trials abcellera.com ↗
Interim data suggests that LY-CoV555 has a direct antiviral effect and may reduce COVID-related hospitalizations |
| 2020-09-16 | Eli Lilly and Company | Results Lilly announces proof of concept data for neutralizing antibody LY-CoV555 in the COVID-19 outpatient setting lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced rate of hospitalization for patients treated with LY-CoV555. |
All press releases naming this drug 43 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bamlanivimab | “remdesivir (Veklury), Colchicine, anti-SARS-CoV-2 monoclonal antibodies, bamlanivimab, Casirivimab \& Imdevimab.” NCT04790240 ↗11“Casirivimab/imdesimab 1200mg/1200mg OR sotrovimab 500mg OR bamlanivimab 700mg IV x1.” NCT04748588 ↗ |
| Known as | LY-CoV555 | “A Pragmatic Eight Week Phase IV Study of Bamlanivimab/LY-CoV555 for Emergency Passive Immunity Against COVID-19” NCT04796402 ↗1“LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)” NCT05780268 ↗ |
| Known as | LY3819253 | “If positive for COVID-19, a one-time at-home infusion of Bamlanivimab (LY3819253) will be provided by Optum Infusion.” NCT04656691 ↗ |
| Modality | Monoclonal antibody | “a neutralizing monoclonal-antibody combination agent (2800 mg of bamlanivimab and 2800 mg of etesevimab, administered together)” PMID 34260849 ↗ Jul 2021 |
| Route | Intravenous | “Administered IV.” NCT04411628 ↗ |