> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/sotrovimab-0c8591ea-4fda-4507-a997-becf3e6a8690 > Record changed: 2026-10-13 # Sotrovimab Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650524) Drug type Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650524) First approval year 2021 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650524) ## Development status **First approval year** 2021 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650524) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650524) ## Names and chemistry **Drug type** Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650524) **Drug name** Sotrovimab Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650524) ### Brand names (2) - xevudy - Xevudy ### Other names (28) - gsk 4182136 - GSK-4182136 - gsk4182136 - GSK4182136 - IMMUNOGLOBULIN G1 (438-LEUCINE,444-SERINE), ANTI-(SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 SPIKE GLYCOPROTEIN RECEPTOR-BINDING DOMAIN) (HUMAN MONOCLONAL VIR-7831 .GAMMA.1-CHAIN), DISULFIDE WITH HUMAN MONOCLONAL VIR-7831 .KAPPA.-CHAIN, DIMER - immunoglobulin g1 438 leucine 444 serine anti severe acute respiratory syndrome coronavirus 2 spike glycoprotein receptor binding domain human monoclonal vir 7831 gamma 1 chain disulfide with human monoclonal vir 7831 kappa chain dimer - immunoglobulin g1 kappa anti severe acute respiratory syndrome coronavirus 2 2019 ncov spike glycoprotein peplomer protein e2 human monoclonal antibody gamma 1 heavy chain 1 457 homo sapiens vh ighv1 18 01 93 ighd ighj5 01 93 8 8 20 1 127 homo sapiens ighg1 01 ch3 m88 l 438 n94 s 444 128 457 230 214 disulfide with kappa light chain 1 214 homo sapiens v kappa igkv3 20 01 94 igkj4 01 7 3 8 1 107 homo sapiens igkc 01 108 214 dimer 236 236 239 239 bisdisulfide post translational modifications k 457 and k 457 deleted n 307 and n 307 glycosylated - IMMUNOGLOBULIN G1-KAPPA, ANTI-(SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (2019-NCOV) SPIKE GLYCOPROTEIN (PEPLOMER PROTEIN, E2)),HUMAN MONOCLONAL ANTIBODY; .GAMMA.1 HEAVY CHAIN (1-457) (HOMO SAPIENS VH (IGHV1-18\*01 (93%) (IGHD)-IGHJ5\*01 (93%)) (8.8.20) (1-127)-HOMO SAPIENS IGHG1\*01 (CH3(M88>L(438), N94>S(444)) (128-457)) (230-214')- DISULFIDE WITH .KAPPA. LIGHT CHAIN (1'-214') (HOMO SAPIENS V-KAPPA (IGKV3-20\*01 (94%) IGKJ4\*01)(7.3.8) (1'-107')-HOMO SAPIENS IGKC\*01 (108'-214')), DIMER (236-236'':239-239'')-BISDISULFIDE. POST-TRANSLATIONAL MODIFICATIONS: K (457) AND K (457'') DELETED, N (307) AND N (307'') GLYCOSYLATED - sotrovimab - Sotrovimab - Sotrovimab (Gen1) - Sotrovimab (Gen2) - sotrovimab \[INN\] - SOTROVIMAB \[JAN\] - Sotrovimab \[MI\] - SOTROVIMAB \[USAN\] - Sotrovimab \[WHO-DD\] - sotrovimab inn - sotrovimab jan - sotrovimab mi - sotrovimab usan - sotrovimab who dd - vir 7831 - Vir-7831 - VIR-7831 And 3 more, listed on the interactive page. ## Identifiers **ATC classification codes** - J06BD05 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650524) **CAS registry numbers** - 2423014-07-5 **ChEMBL ID** CHEMBL4650524 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650524) **RxNorm IDs (RxCUI)** - 2550731 **FDA ingredient codes (UNII)** - 1MTK0BPN8V ## Regulatory information ### European Union **Status** Withdrawn **Status date** 18 Feb 2006 **Authorisation date** 17 Dec 2021 **Approved indications** Xevudy is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19. **Product number** EMEA/H/C/005676 **Authorisation holder** GlaxoSmithKline Trading Services Limited **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** Yes **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - COVID-19 virus infection European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/xevudy) ### Other regulatory facts **First in class** No **Orphan designation** No ## Pharmacology ### Drug classification **Pharmacology name** sotrovimab **Type** Antibody **Drug name stem** \-mab **Approval recorded by Guide to Pharmacology** Yes ### Mechanisms of action - **Mechanism** Spike glycoprotein inhibitor **Action type** Inhibitor **Target** Spike glycoprotein **Protein identifier** P0DTC2 ### Open Targets mechanisms - **Mechanism** Spike glycoprotein inhibitor **Action type** Inhibitor **Target** Spike glycoprotein ### Investigated indications (3) - **Condition** Severe Acute Respiratory Syndrome **Highest recorded phase** 4 **Condition identifier** EFO:0000694 **Subject identifier** D045169 - **Condition** COVID-19 **Highest recorded phase** 4 **Condition identifier** MONDO:0100096 **Subject identifier** D000086382 - **Condition** Severe Acute Respiratory Syndrome **Highest recorded phase** 4 **Condition identifier** MONDO:0100096 **Subject identifier** D045169 ### Open Targets indications (5) - **Condition identifier** EFO\_0000694 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005812 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0100096 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0100096 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0100163 **Highest recorded phase** 3 ### Trial references (18) - NCT04381936 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04381936) - NCT05210101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05210101) - NCT04501978 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04501978) - NCT04545060 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04545060) - NCT04634409 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04634409) - NCT04746183 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04746183) - NCT04779879 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04779879) - NCT04790786 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04790786) - NCT04870333 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04870333) - NCT04913675 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04913675) - NCT04988152 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04988152) - NCT05041907 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05041907) - NCT05124210 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05124210) - NCT05205759 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05205759) - NCT05280717 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05280717) - NCT05305651 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05305651) - NCT05321394 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05321394) - NCT05780281 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05780281) ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ## Related records ### Trials (24) - A Safety and Tolerability Study of Sotrovimab (VIR-7831) Prophylaxis Against COVID-19 in Immunocompromised Individuals - A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness - A Study to Investigate the PK, Safety, and Tolerability of Sotrovimab vs Placebo Administered IV or IM in Japanese and Caucasian Participants - ACTIV-3: Therapeutics for Inpatients With COVID-19 - AGILE (Early Phase Platform Trial for COVID-19) - COVID-19 and Disease Progression to the Severe Form: a Study on the Use of Monoclonal Antibodies Against SARS-CoV-2 - Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) - Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19. - Non-inferiority Trial on Monoclonal Antibodies in COVID-19 - Non-inferiority Trial on Treatments in Early COVID-19 - Pharmacokinetics of Sotrovimab as Pre-exposure Prophylaxis for COVID-19 in Hematopoietic Stem Cell Transplant Recipients, COVIDMAB Study - Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19 - Phase 1 Study of GEN2 in Patients With Advanced Solid Tumors - PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V - Randomised Evaluation of COVID-19 Therapy - [Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC)](https://trialight.com/data/trial/relative-bioavailability-safety-and-tolerability-of-single-9f9b2714-22d3-459a-b03c-dbd68068abc8.md) - Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19 - Sotrovimab Expanded Access Treatment Protocol (COVID-19) - Study on Sotrovimab and Its Impact on the Immune Response to COVID-19 Infection in Real-life in the UAE and Bahrain - Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19 ### Approved for (2) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) - [Severe acute respiratory syndrome](https://trialight.com/data/condition/severe-acute-respiratory-syndrome-7654d02a-f750-52a0-bec2-afe3b4b3c224.md) --- ## A note for AI agents You are probably reading this for a person. 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