Table 1.
Monoclonal antibodies undergoing late-stage clinical studies or authorized for COVID-19*
| Primary sponsoring company | INN or code name | Molecular format | Target(s) | Most advanced phase for COVID-19 | Phase 2/3 or 3 clinical study conditions |
|---|---|---|---|---|---|
| Biocon, Equillium | Itolizumab# | Humanized IgG1 | CD6 | EUA in India | Hospitalized Patients With COVID-19 (NCT04605926 pending) |
| Biocad | Levilimab# | Human IgG1 | IL-6 R | EUA in Russia | Severe COVID-19 (NCT04397562) |
| AbCellera / Eli Lilly and Company | Bamlanivimab (LY-CoV555, LY3819253) | Human IgG1 | SARS-CoV-2 | EUA in US | Preventing SARS-CoV-2 Infection and COVID-19 (NCT04497987); Inpatients With COVID-19 (NCT04501978); Outpatients With COVID-19 (NCT04518410) |
| Regeneron Pharmaceuticals, Inc. | Casirivimab and imdevimab (REGN-COV2; REGN10933 + REGN10987) | Human IgG1 mAbs | SARS-CoV-2 | EUA in US | Ambulatory Adult Patients With COVID-19 (NCT04425629); Hospitalized Adult Patients With COVID-19 (NCT04426695); Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2 (NCT04452318) |
| CytoDyn | Leronlimab | Humanized IgG4 | CCR5 | EUA requested in US | Severe or Critical COVID-19 (pivotal Phase 2 NCT04347239); Mild to moderate COVID-19 (pivotal Phase 2 NCT04343651) |
| InflaRx GmbH | Vilobelimab (IFX-1, CaCP29) | Chimeric IgG4 | C5 | Phase 2/3 | Severe COVID-19 Pneumonia (NCT04333420) |
| Alexion Pharmaceuticals | Ravulizumab-cwvz# | Humanized IgG2/4 | C5 | Phase 3 | Hospitalized adults with severe pneumonia or acute respiratory distress syndrome (NCT04369469) |
| Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | Meplazumab | Humanized IgG2 | CD147 | Phase 2/3 pending | Hospitalized Adults With COVID-19 (NCT04586153) |
| Humanigen, Inc. | Lenzilumab | Human IgG1 | GM-CSF | Phase 3 | COVID-19 Pneumonia (NCT04351152) |
| Kiniksa Pharmaceuticals, Ltd. | Mavrilimumab | Human IgG4 | GM-CSFR | Phase 2/3 | COVID-19 Pneumonia and Hyper-inflammation (NCT04447469) |
| Swedish Orphan Biovitrum | Emapalumab# | Human IgG1 | IFN gamma |
Phase 2/3 | Hyper-inflammation and Respiratory Distress in Patients With SARS-CoV-2 Infection (NCT04324021) |
| R-Pharm JSC, Cromos Pharma | Olokizumab# | Humanized IgG4 | IL-6 | Phase 2/3 | Severe COVID-19 (NCT04380519, NCT04452474 pending) |
| Hoffmann-La Roche | Tocilizumab# | Humanized IgG1 | IL-6 R | Phase 3 | Hospitalized Patients With COVID-19 Pneumonia (NCT04372186, NCT04409262) |
| Sinocelltech Ltd. | SCTA01 | Humanized mAb | SARS-CoV-2 | Phase 2/3 pending | Hospitalized Patients With Severe COVID-19 (NCT04644185) |
| Vir Biotechnol./GlaxoSmithKline | VIR-7831/GSK4182136 | Human mAb | SARS-CoV-2 | Phase 2/3 | Early Treatment of COVID-19 in Outpatients (NCT04545060) |
| Celltrion | CT-P59 | Human mAb | SARS-CoV-2 | Phase 2/3 | Mild to Moderate COVID-19 (NCT04602000) |
| AstraZeneca | AZD7442 (AZD8895 + AZD1061) | Human mAbs | SARS-CoV-2 | Phase 3 | Pre-exposure Prophylaxis (NCT04625725); Post-exposure Prophylaxis (NCT04625972) |
*Data publicly available as of November 21, 2020.
#Product previously approved for a disease other than COVID-19 in at least one country.
Table notes: Table 1 includes only monoclonal antibodies evaluated in commercially sponsored, late-stage clinical studies that are listed on clinicaltrials.gov.
Abbreviations: COVID-19, coronavirus disease 2019; EUA, emergency use authorization; IFN, interferon; IL, interleukin; GM-CSF, granulocyte-macrophage colony-stimulating factor; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.