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| Withdrawn | EU (EMA) | Bamlanivimab and etesevimab for COVID-19 | — | 2021-10-29 | europa.eu ↗ |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 · a red edge is where a trial was stopped
| 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 | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT04501978 | Aug 2020 → Apr 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT04497987 | Aug 2020 → Jan 2021 | COVID-19 | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| 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 | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT04790240 Comparator | Jan 2025 → Dec 2026 expected | COVID-19 | All Natural Medicine Clinic, LLC | Recruiting | No outcome recorded |
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 ↗ |