Drugs / Etesevimab
Etesevimab
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| Withdrawn | EU (EMA) | Bamlanivimab and etesevimab for COVID-19 | — | 2021-10-29 | europa.eu ↗ |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 9 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04611789 | Nov 2020 → Feb 2021 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04441931 | Jun → Oct 2020 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04441918 | Jun → Dec 2020 | COVID-19 | Shanghai Junshi Bioscience Co., Ltd. | Unknown | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04931238 | Jan → Dec 2021 | COVID-19 | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04634409 | Oct 2020 → Jul 2021 | COVID-19 | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04427501 | Jun 2020 → Feb 2023 | COVID-19 | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05205759 | Dec 2021 → Feb 2022 | COVID-19 | Azienda Ospedaliera Universitaria Integrata Verona | Terminated | No outcome recorded |
| Phase 3 | NCT04497987 | Aug 2020 → Jan 2021 | COVID-19 | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04790786 | Mar 2021 → Jun 2022 | COVID-19 | Erin McCreary | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05167279 Comparator | Dec 2021 → Dec 2022 | COVID-19 | Shanghai Junshi Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04780321 Comparator | Oct 2020 → Aug 2021 | COVID-19 | Shanghai Junshi Bioscience Co., Ltd. | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Etesevimab | “This study is the first to report the tolerability, safety, pharmacokinetics (PK), and immunogenicity of a recombinant human anti-SARS-CoV-2 monoclonal antibody, etesevimab...” PMID 33972256 ↗ Jul 2021 |
| Known as | Anti-sars-cov-2 antibody js016 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650488 ↗ |
| Known as | CB6 | “This study is the first to report the tolerability, safety, pharmacokinetics (PK), and immunogenicity of a recombinant human anti-SARS-CoV-2 monoclonal antibody, etesevimab...” PMID 33972256 ↗ Jul 2021 |
| Known as | JS016 | “intravenous Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody (JS016)” NCT04780321 ↗ |
| Known as | LY-CoV016 | “This study is the first to report the tolerability, safety, pharmacokinetics (PK), and immunogenicity of a recombinant human anti-SARS-CoV-2 monoclonal antibody, etesevimab...” PMID 33972256 ↗ Jul 2021 |
| Known as | LY3832479 | “This study is the first to report the tolerability, safety, pharmacokinetics (PK), and immunogenicity of a recombinant human anti-SARS-CoV-2 monoclonal antibody, etesevimab...” PMID 33972256 ↗ Jul 2021 |
| Known as | NP-005 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650488 ↗ |
| Action | Inhibit | “JS016 showed neutralizing and therapeutic effects” PMID 35191746 ↗ Mar 2022 |
| 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” NCT04427501 ↗ |