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))

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) is in 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 is 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.

Summary of Clinical Use

Sotrovimab (VIR-7831) is in 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 is 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.

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)