sotrovimab

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Ligands
sotrovimab

GtoPdb Ligand ID: 11333

Synonyms: GSK-4182136 | GSK4182136 | VIR-7831 | VIR7831 | Xevudy®

sotrovimab is an approved drug (UK & EMA (2021))

Compound class: Antibody

Comment: Sotrovimab (VIR-7831) is a monoclonal antibody that binds to a highly conserved epitope within the surface spike glycoprotein of sarbecoviruses. The parental antibody, from which sotrovimab was derived, was originally identified in the memory B cells of a patient who had recovered from SARS-CoV infection. Sotrovimab was progressed by GSK and Vir Biotechnology as a COVID-19 therapeutic [4]. Sotrovimab retains some activity against the omicron BA.1 (B.1.1.529) SARS-CoV-2 variant (bioRxiv preprint [1]), but it activity against the BA.2 omicron subvariant is lower [3].

No information available.

No information available.

Summary of Clinical Use
Sotrovimab (VIR-7831) was progressed to clinical evaluation for COVID-19. In March 2021, Vir Biotechnology and GlaxoSmithKline announced that they were stopping enrollment into their Phase 3 trial for efficacy, following an interim review revealed that sotrovimab reduced hospitalisation or death by 85%. As of October 2021, sotrovimab had been granted emergency use authorisations as a COVID-19 therapy, in markets including the United States. The UK's MHRA granted full approval for sotrovimab (Xevudy®) in October 2021. Under this authorisation it was indicated as a treatment for patients with mild to moderate COVID-19 who have at least one risk factor for developing severe disease. EMA approval was issued in December 2021, but this was withdrawn in early 2026.

Summary of Clinical Use

Sotrovimab (VIR-7831) was progressed to clinical evaluation for COVID-19. In March 2021, Vir Biotechnology and GlaxoSmithKline announced that they were stopping enrollment into their Phase 3 trial for efficacy, following an interim review revealed that sotrovimab reduced hospitalisation or death by 85%. As of October 2021, sotrovimab had been granted emergency use authorisations as a COVID-19 therapy, in markets including the United States. The UK's MHRA granted full approval for sotrovimab (Xevudy®) in October 2021. Under this authorisation it was indicated as a treatment for patients with mild to moderate COVID-19 who have at least one risk factor for developing severe disease. EMA approval was issued in December 2021, but this was withdrawn in early 2026.

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT04545060	VIR-7831 for the Early Treatment of COVID-19 in Outpatients	Phase 2/Phase 3 Interventional	Vir Biotechnology, Inc.	COMET-ICE study
NCT04913675	Intramuscular VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19	Phase 3 Interventional	Vir Biotechnology, Inc.
NCT04779879	Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19	Phase 2 Interventional	Vir Biotechnology, Inc.	COMET-PEAK study
NCT04501978	ACTIV-3: Therapeutics for Inpatients With COVID-19	Phase 3 Interventional	National Institute of Allergy and Infectious Diseases (NIAID)

External links
For extended ADME data see the following: Electronic Medicines Compendium (eMC) European Medicines Agency (EMA)

External links

For extended ADME data see the following:

Electronic Medicines Compendium (eMC)
European Medicines Agency (EMA)