Drugs / Sotrovimab
last change Feb 2026 re-read 9 days ago

Sotrovimab

also known as VIR-7831 · GSK4182136 · SOT · Xevudy

Monoclonal antibody

Developed for
COVID-19 · nosocomial infection · pneumonia
Investigated by
GlaxoSmithKline · Vir Biotechnology, Inc. · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Cardiothoracic Surgical Trials Network · Eli Lilly and Company · International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
+34 more · Kirby Institute · Medical Research Council · National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Allergy and Infectious Diseases (NIAID) · Prevention and Early Treatment of Acute Lung Injury · US Department of Veterans Affairs · University of Copenhagen · University of Minnesota · Washington D.C. Veterans Affairs Medical Center · AbCellera Biologics Inc. · Addenbrookes Charitable Trust · Agenzia Italiana del Farmaco · AstraZeneca · Azienda Ospedaliera Universitaria Integrata Verona · Azienda Sanitaria-Universitaria Integrata di Udine · Brii Biosciences Limited · Cambridge University Hospitals NHS Foundation Trust · Dana-Farber Cancer Institute · Erin McCreary · Fred Hutchinson Cancer Center · Kidney Research UK (KRUK) · LifeArc · Massachusetts General Hospital · Molecular Partners AG · National Institute for Health Research, United Kingdom · National Marrow Donor Program · Pfizer · Shanghai Junshi Bioscience Co., Ltd. · Sophia Koo, M.D. · Sunnybrook Research Institute · UNION therapeutics · University of Calgary · University of Oxford · University of Pittsburgh

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed COVID-19 2 milestones
Filed US (FDA) — COVID-19 —

“An Emergency Use Authorization (EUA) application for sotrovimab has been submitted to the US Food and Drug Administration (FDA).” vir.bio ↗

Filed EU (EMA) Xevudy COVID-19 —

“GSK and Vir also recently submitted the Marketing Authorization Application (MAA) to the European Medicines Agency for Xevudy (sotrovimab)” vir.bio ↗

“GSK and Vir also recently submitted the Marketing Authorisation Application (MAA) to the European Medicines Agency for Xevudy (sotrovimab)” gsk.com ↗

“GSK and Vir also recently submitted the Marketing Authorization Application to the European Medicines Agency for Xevudy” vir.bio ↗

“GSK and Vir also recently submitted the Marketing Authorisation Application to the European Medicines Agency for Xevudy” gsk.com ↗

“GSK and Vir also recently submitted the Marketing Authorization Application to the European Medicines Agency for Xevudy” vir.bio ↗

Approved Indication not stated 1 milestone
Approved EU (EMA) Xevudy — 2026-02-18 europa.eu ↗

Trials 16

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT05280717 Mar 2022 → Apr 2023 COVID-19 Vir Biotechnology, Inc. Terminated No outcome recorded
Phase 1 NCT05135650 Jan → Oct 2022 COVID-19, cancer, hematopoietic and lymphoid cell neoplasm Fred Hutchinson Cancer Center Terminated No outcome recorded
Phase 1 NCT04988152 Jul → Sep 2021 COVID-19 Vir Biotechnology, Inc. Completed No outcome recorded
Phase 24 trials
Phase 2 NCT05210101 Feb 2022 → Feb 2023 COVID-19 Sophia Koo, M.D. Completed No outcome recorded
Phase 2 NCT05124210 Dec 2021 → Jun 2023 COVID-19 GlaxoSmithKline Terminated No outcome recorded
Phase 2 NCT05041907 Sep 2021 → Jan 2027 expected COVID-19 University of Oxford Recruiting Mixed
Phase 2 NCT04634409 Oct 2020 → Jul 2021 COVID-19 Eli Lilly and Company Completed Mixed
Phase 2/32 trials · 1 met primary · 1 missed
Phase 2/3 NCT04870333 Feb 2021 → Apr 2025 COVID-19 Cambridge University Hospitals NHS Foundation Trust Completed Missed primary
Phase 2/3 NCT04545060 Aug 2020 → Apr 2021 COVID-19 Vir Biotechnology, Inc. Completed Met primary
Phase 34 trials · 1 met primary · 1 missed
Phase 3 NCT05205759 Dec 2021 → Feb 2022 COVID-19 Azienda Ospedaliera Universitaria Integrata Verona Terminated No outcome recorded
Phase 3 NCT04913675 Jun 2021 → Jul 2022 COVID-19 Vir Biotechnology, Inc. Terminated Met primary
Phase 3 NCT05780281 Dec 2020 → Jun 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 Missed primary
Phase 42 trials · 1 missed
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 not stated1 trial
— NCT05235347 — COVID-19 Vir Biotechnology, Inc. No longer available No outcome recorded
Comparator or background therapy6 trials
Phase 1/2 NCT04746183 Comparator Jul 2020 → Mar 2027 expected COVID-19 University of Liverpool Recruiting Missed primary
Phase 2 NCT04779879 Comparator Feb → Aug 2021 COVID-19 Vir Biotechnology, Inc. Completed No outcome recorded
Phase 3 NCT05271929 Background Apr 2022 → Jan 2024 COVID-19 German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen Terminated Met primary Stop: Enrollment
Phase 3 NCT05321394 Comparator Mar 2022 → Oct 2023 COVID-19 Azienda Ospedaliera Universitaria Integrata Verona Completed No outcome recorded
Phase 3 NCT04381936 Comparator Mar 2020 → Sep 2028 expected pneumonia University of Oxford Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 41

DateIssuerRelease
2023-02-22 Vir Biotechnology, Inc. Regulatory Vir Biotechnology Announces Positive Final Draft Guidance on Sotrovimab from the UK’s National Institute for Health and Care Excellence (NICE) vir.bio ↗
2022-03-25 Vir Biotechnology, Inc. Regulatory US Food and Drug Administration Revises Emergency Use Authorization for Sotrovimab Due to Omicron BA.2 Subvariant vir.bio ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the US Food and Drug Administration has amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab, an investigational monoclonal antibody.
2022-02-10 Vir Biotechnology, Inc. Results Data Suggest Sotrovimab Retains Neutralizing Activity Against Omicron Subvariant BA.2 vir.bio ↗
Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that preclinical data suggest that sotrovimab, an investigational monoclonal antibody authorized for emergency use in the United States and developed in conjunction with GlaxoSmithKline, retains neutralizing activity against the BA.2 subvariant of Omicron.
2022-01-13 Vir Biotechnology, Inc. Regulatory GSK and Vir Submit Emergency Use Authorization Application to FDA for Intramuscular Administration of Sotrovimab for the Early Treatment of COVID-19 vir.bio ↗
2021-12-31 Vir Biotechnology, Inc. Results Vir Biotechnology Announces New Research Describing the Structural Basis of SARS-CoV-2 Omicron Immune Evasion and Receptor Engagement vir.bio ↗
Further, these data add to the growing body of evidence from recent pseudo- and live virus neutralization findings1,2 demonstrating that sotrovimab retains activity against the Omicron variant, as well as all tested variants of concern3.
2021-12-17 GlaxoSmithKline Regulatory Xevudy (sotrovimab) granted marketing authorisation by the European Commission for the early treatment of COVID-19 gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the European Commission (EC) has granted marketing authorisation to Xevudy (sotrovimab) for the early treatment of COVID-19.
2021-12-17 Vir Biotechnology, Inc. Regulatory Xevudy (Sotrovimab) Granted Marketing Authorization by the European Commission for the Early Treatment of COVID-19 vir.bio ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the European Commission (EC) has granted marketing authorization to Xevudy (sotrovimab) for the early treatment of COVID-19.
2021-12-14 Vir Biotechnology, Inc. Results Preclinical Data Highlight the Significant Antigenic Shift of the Omicron SARS-CoV-2 Variant and its Effect on the Neutralizing Activity of Monoclonal Antibodies, Convalescent Antibodies and Vaccine-Elicited Antibodies vir.bio ↗
Data demonstrate that sotrovimab and five other preclinical mAbs, developed by Vir in conjunction with GlaxoSmithKline, retained their in vitro neutralizing activity against Omicron.
2021-12-07 GlaxoSmithKline Results Preclinical studies demonstrate sotrovimab retains activity against the full combination of mutations in the spike protein of the Omicron SARS-CoV-2 variant gsk.com ↗
2021-12-07 Vir Biotechnology, Inc. Results Vir Biotechnology to Host a Call on Sotrovimab’s Retained Activity Against the Omicron SARS-CoV-2 Variant vir.bio ↗
Vir Biotechnology, Inc. (Nasdaq: VIR) announced that Management will host a conference call at 8:30 am ET, Tuesday, December 7, 2021, to discuss new data that demonstrates sotrovimab retains activity against the full combination of mutations in the spike protein of the Omicron SARS-CoV-2 variant.
2021-12-07 Vir Biotechnology, Inc. Results Preclinical Studies Demonstrate Sotrovimab Retains Activity Against the Full Combination of Mutations in the Spike Protein of the Omicron SARS-CoV-2 Variant vir.bio ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced an update to preclinical data on bioRxiv1, a preprint server, demonstrating that sotrovimab, an investigational monoclonal antibody, retains in vitro activity against the full known Omicron spike protein, the new SARS-CoV-2 variant (B.1.1.529).
2021-12-02 GlaxoSmithKline Results Preclinical data demonstrate sotrovimab retains activity against key Omicron mutations, new SARS-CoV-2 variant gsk.com ↗

All press releases naming this drug 55 releases

DateIssuerRelease

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 24 sources stand behind the page.

FieldValueCited text
Known as sotrovimab “Casirivimab/imdesimab 1200mg/1200mg OR sotrovimab 500mg OR bamlanivimab 700mg IV x1.” NCT04748588 ↗
17

“Sotrovimab (Xevudy)” NCT05271929 ↗

NCT04545060 ↗

NCT05041907 ↗

NCT04870333 ↗

NCT05305651 ↗

NCT05124210 ↗

NCT04913675 ↗

NCT05210101 ↗

NCT05235347 ↗

NCT04381936 ↗

Show 7 more sources

Known as GSK4182136 “Sotrovimab, VIR-7831, GSK4182136 Sterile solution for intravenous infusion, 62.5 mg/mL, intravenous infusion” NCT04870333 ↗
Known as SOT “500 mg of intravenous sotrovimab (SOT)” PMID 39343244 ↗ Sep 2024
Known as VIR-7831 “This is a phase 2 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 (Sotrovimab) Generation 1 (Gen1) or VIR-7831 (Sotrovimab) Generation 2...” NCT04779879 ↗
6

“Sotrovimab, VIR-7831, GSK4182136 Sterile solution for intravenous infusion, 62.5 mg/mL, intravenous infusion” NCT04870333 ↗

“VIR-7831 (sotrovimab) given by intravenous infusion (single dose)” NCT04545060 ↗

NCT05780281 ↗

NCT04634409 ↗

NCT04746183 ↗

NCT04501978 ↗

Known as Xevudy “Sotrovimab (Xevudy)” NCT05271929 ↗
Action Inhibit “neutralising monoclonal antibody” PMID 40886716 ↗ Aug 2025
Modality Monoclonal antibody “neutralising monoclonal antibody” PMID 40886716 ↗ Aug 2025
Route Intravenous “by intravenous infusion” NCT04381936 ↗