Garadacimab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | Coagulation factor XIIa |
| Clinical data | |
| Trade names | Andembry |
| Other names | CSL-312, garadacimab-gxii |
| AHFS/Drugs.com | Andembry |
| License data |
|
| Routes of administration | Subcutaneous |
| Drug class | Bleeding suppressant |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6470H10004N1724O2022S42 |
| Molar mass | 145639.77 g·mol−1 |
Garadacimab, sold under the brand name Andembry, is a human monoclonal antibody used for the treatment of hereditary angioedema.[5][6] Garadacimab is a monoclonal antibody against the activated coagulation factor XIIa (FXIIa), with potential anti-inflammatory and anticoagulant activities.[8][9]
Garadacimab is a fully human, recombinant, IgG4 lambda monoclonal antibody that binds to the catalytic domain of activated factor XII (FXIIa).[6] FXIIa is the first factor activated in the contact system, which leads to the production of bradykinin.[6] The inhibition of FXIIa therefore prevents the activation of prekallikrein into kallikrein and the generation of bradykinin, which is associated with inflammation and swelling in attacks of hereditary angioedema.[6]
Garadacimab was authorized for medical use in the European Union in February 2025,[6][7] and approved in the United States in June 2025.[10][11]
- ^ https://www.tga.gov.au/resources/prescription-medicines-registrations/andembry-csl-behring-australia-pty-ltd Archived 17 April 2025 at the Wayback Machine
- ^ https://www.tga.gov.au/resources/artg/443611
- ^ https://www.tga.gov.au/resources/artg/428253 Archived 18 April 2025 at the Wayback Machine
- ^ "Andembry 200 mg Solution for injection in pre-filled pen". (emc). 11 March 2025. Archived from the original on 21 March 2025. Retrieved 12 March 2025.
- ^ a b "Andembry- garadacimab injection, solution". DailyMed. 19 June 2025. Retrieved 6 July 2025.
- ^ a b c d e f Cite error: The named reference
Andembry EPARwas invoked but never defined (see the help page). - ^ a b Cite error: The named reference
Andembry PIwas invoked but never defined (see the help page). - ^ "Garadacimab (Code C166633)". NCI Thesaurus. 25 November 2024. Archived from the original on 15 June 2024. Retrieved 13 December 2024. This article incorporates text from this source, which is in the public domain.
- ^ Cohn DM, Renné T (October 2024). "Targeting factor XIIa for therapeutic interference with hereditary angioedema". Journal of Internal Medicine. 296 (4): 311–326. doi:10.1111/joim.20008. PMID 39331688.
- ^ Cite error: The named reference
Novel Drug Approvals for 2025was invoked but never defined (see the help page). - ^ https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761367Orig1s000ltr.pdf