Sipavibart
Highest phase reached
Phase 2
Drug type
Antibody
- Listing at source
- Listed
- Highest phase reached
- Phase 2
- Drug type
- Antibody
- Drug name
- Sipavibart
- azd 3152
- AZD-3152
- azd3152
- Azd3152
- AZD3152
- AZD3152 (Cohort 1)
- AZD3152 (Cohort 2)
- AZD3152 (Cohort 3)
- AZD3152 (Parent study Main Cohort)
- AZD3152 (Sub-study)
- Biological: AZD3152
- Gamma1 heavy chain Homo sapiens (1-455) [VH (Homo sapiens IGHV3-9*01 (94.9%) -(IGHD) -IGHJ1*01 (90.9%) L123>T (120), CDR-IMGT [8.8.18] (26-33.51-58.97-114)) (1-125) -Homo sapiens IGHG1*03, G1m3, nG1m1 CH1 R120, CH3 E12, M14, IGHG1v39 CH2 F1.3, E1.2, S116, IGHG1v21 CH2 Y15.1, T16, E18 (CH1 R120 (222) (126-223), hinge 1-15 (224-238), CH2 L1.3>F (242), L1.2>E (243), M15.1>Y (260), S16>T (262), T18>E (264), P116>S (339) (239-348), CH3 E12 (364), M14 (366) (349-453), CHS (454-455)) (126-455)], (228-214')-disulfide with lambda light chain Homo sapiens (1'-215') [V- LAMBDA (Homo sapiens IGLV2-8*04 (94.8%) -IGLJ2*01 (100%), CDR-IMGT [9.3.9] (26-34.52-54.91-99)) (1'-109') -Homo sapiens IGLC2*01 (100%) (110'-215')]; dimer (234-234'':237-237'')-bisdisulfide, produced in Chinese hamster ovary (CHO) cells, derived from the cell line CHO-K1, glycoform alfa
- gamma1 heavy chain homo sapiens 1 455 vh homo sapiens ighv3 9 01 94 9 ighd ighj1 01 90 9 l123 t 120 cdr imgt 8 8 18 26 33 51 58 97 114 1 125 homo sapiens ighg1 03 g1m3 ng1m1 ch1 r120 ch3 e12 m14 ighg1v39 ch2 f1 3 e1 2 s116 ighg1v21 ch2 y15 1 t16 e18 ch1 r120 222 126 223 hinge 1 15 224 238 ch2 l1 3 f 242 l1 2 e 243 m15 1 y 260 s16 t 262 t18 e 264 p116 s 339 239 348 ch3 e12 364 m14 366 349 453 chs 454 455 126 455 228 214 disulfide with lambda light chain homo sapiens 1 215 v lambda homo sapiens iglv2 8 04 94 8 iglj2 01 100 cdr imgt 9 3 9 26 34 52 54 91 99 1 109 homo sapiens iglc2 01 100 110 215 dimer 234 234 237 237 bisdisulfide produced in chinese hamster ovary cho cells derived from the cell line cho k1 glycoform alfa
- immunoglobulin g1 lambda anti homo sapiens severe acute respiratory syndrome coronavirus 2 sars cov 2 spike s protein receptor binding domain rbd homo sapiens monoclonal antibody
- Immunoglobulin G1-lambda, anti-[Homo sapiens severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein, receptor binding domain (RBD)], Homo sapiens monoclonal antibody
- rq043
- RQ043
- sipavibart
- Sipavibart
- sipavibart [INN]
- SIPAVIBART [USAN]
- Sipavibart [WHO-DD]
- sipavibart inn
- sipavibart usan
- sipavibart who dd
- ATC classification codes
- J06BD09
Sources for recorded values
- CAS registry numbers
- 2768288-97-5
- ChEMBL ID
- CHEMBL5315011
- FDA ingredient codes (UNII)
- 977D2P9YYW
- Status
- Authorised
- Status date
- 20 Jan 2025
- Authorisation date
- 20 Jan 2025
- Approved indications
- Kavigale is indicated for the pre-exposure prophylaxis of COVID-19 in adults and adolescents 12 years of age and older weighing at least 40 kg and who are immunocompromised due to a medical condition or receipt of immunosuppressive treatments.Kavigale should be used in accordance with official recommendations where available and based on information on the activity of sipavibart against presently circulating viral variants (see sections 4.4 and 5.1).
- Product number
- EMEA/H/C/006291
- Authorisation holder
- AstraZeneca AB
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- COVID-19 virus infection
European medicines record
- First in class
- No
- Orphan designation
- No
- Pharmacology name
- sipavibart
- Type
- Antibody
- Drug name stem
- -bart
- Approval recorded by Guide to Pharmacology
- Yes
- Condition
- Virus Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000763
- Subject identifier
- D014777
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0100096
- Subject identifier
- D045169
- Condition identifier
- EFO_0000763
- Condition identifier
- MONDO_0005108
- Condition identifier
- MONDO_0100096
- NCT05648110
- NCT05872958
- NCT05932641
- NCT06057064
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Glycosylation sites (N)
- Sequence
- 305 $ 305''
- Component
- Heavy chain
- Type
- Protein
- Sequence
- EVQLVESGGGLVQPGRSLRLSCAASGFPFDDYAIHWVRLAPGKGLEWVSSISWDSGSIGYADSVKGRFTISRDNAKNSLYLQMNSLRAEDTALYYCAKGAFPGYSSGWYYGLEVWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPEFEGGPSVFLFPPKPKDTLYITREPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPASIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Light chain
- Type
- Protein
- Sequence
- QSVVTQPPSASGSLGQSVTISCTGTSSDVGGYNYVSWYQQHPGKAPKLMIFEVSKRPSGVPDRFSGSKSGNTASLTVSGLQAEDEADYYCSSYAGNKGVFGGGTKLTVLGQPKAAPSVTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS
- Component
- Disulfide bridges
- Sequence
- 22'-90' $ 22'''-90''' $ 22-96 $ 22''-96'' $ 137'-196' $ 137'''-196''' $ 152-208 $ 152''-208'' $ 228-214' $ 228''-214''' $ 234-234'' $ 237-237'' $ 269-329 $ 269''-329'' $ 375-433 $ 375''-433''
Related records
Trials (7)
- Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response Study
- Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
- Mechanisms and Treatment of Post-amputation Neuropathic Pain
- Parent Study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA Sub-study)
- SARS-CoV-2 Specific Monoclonal Antibody for Post-COVID-19 Conditions (Long COVID)
- Study of AZD3152 Intramuscular Injection or Intravenous Infusion in Healthy Japanese Adult Participants
- Study Will Assess the Safety, Neutralizing Activity and Efficacy of AZD3152 in Adults With Conditions Increasing Risk of Inadequate Protective Immune Response After Vaccination and Thus Are at High Risk of Developing Severe COVID-19
In development for (2)
- COVID-19 Phase 2
- Viral infectious disease Phase 2