Sotrovimab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2021
- First approval year
- 2021
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Sotrovimab
- xevudy
- Xevudy
- 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.
- ATC classification codes
- J06BD05
Sources for recorded values
- CAS registry numbers
- 2423014-07-5
- ChEMBL ID
- CHEMBL4650524
- RxNorm IDs (RxCUI)
- 2550731
- FDA ingredient codes (UNII)
- 1MTK0BPN8V
- 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
- First in class
- No
- Orphan designation
- No
- 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
- 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
- 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
- NCT04381936
- NCT05210101
- NCT04501978
- NCT04545060
- NCT04634409
- NCT04746183
- NCT04779879
- NCT04790786
- NCT04870333
- NCT04913675
- NCT04988152
- NCT05041907
- NCT05124210
- NCT05205759
- NCT05280717
- NCT05305651
- NCT05321394
- NCT05780281
- 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)
- 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