Last update 16 May 2025

Garadacimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-FXIIa monoclonal antibody, Immunoglobulin G4, anti-(human blood-coagulation factor viia) (human monoclonal CSL312 gamma4-chain), disulfide with human monoclonal CSL312 lambda-chain, dimer, CSL-312
+ [2]
Action
inhibitors
Mechanism
F12 inhibitors(Coagulation factor XII inhibitors), Factor XIIa inhibitors(Factor XIIa inhibitors)
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United Kingdom (24 Jan 2025),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Hereditary Angioedema
Australia
24 Jan 2025
Hereditary Angioedema
United Kingdom
24 Jan 2025
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Idiopathic Pulmonary FibrosisPhase 2
United States
03 Feb 2022
Idiopathic Pulmonary FibrosisPhase 2
Australia
03 Feb 2022
Idiopathic Pulmonary FibrosisPhase 2
Austria
03 Feb 2022
Idiopathic Pulmonary FibrosisPhase 2
Belgium
03 Feb 2022
Idiopathic Pulmonary FibrosisPhase 2
Canada
03 Feb 2022
Idiopathic Pulmonary FibrosisPhase 2
Denmark
03 Feb 2022
Idiopathic Pulmonary FibrosisPhase 2
Germany
03 Feb 2022
Idiopathic Pulmonary FibrosisPhase 2
Italy
03 Feb 2022
Idiopathic Pulmonary FibrosisPhase 2
Poland
03 Feb 2022
Idiopathic Pulmonary FibrosisPhase 2
Spain
03 Feb 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
81
(Garadacimab)
kgvgbmwmmz = rlzyxgxtcq bodcfdbfwt (vfvdbtlocu, ndxdvjirgl - drhdacstyu)
-
13 Dec 2024
Placebo
(Placebo)
kgvgbmwmmz = ousyrkybaf bodcfdbfwt (vfvdbtlocu, uupxxkqbyn - hrdiflwlti)
Phase 1
-
132
wkzqmxsiit(qpbvltwecm) = tdfgqscusq niqgdhtvei (jdkevmgcaw )
Positive
23 Feb 2024
wkzqmxsiit(qpbvltwecm) = uuiqrmgxse niqgdhtvei (jdkevmgcaw )
Phase 2/3
Hereditary Angioedema
activated factor XII
172
Garadacimab 75 mg
qhcpnpfsvq(vfeuqwsxrn) = The most common garadacimab-related TEAEs were mild/moderate injection-site reactions qivekoatet (xgtkoyftnv )
Positive
23 Feb 2024
Phase 3
64
(CSL312)
obvjcqtjgn(uovcesgdaq) = jtfdjvwdeq iffxpkwndr (xcmkzixilh, 0.683)
-
29 Jun 2023
Placebo
(Placebo)
obvjcqtjgn(uovcesgdaq) = mqgrsbnmaq iffxpkwndr (xcmkzixilh, 1.341)
Phase 3
65
lxbwqevela(auczczlepk) = esnpugwlir guqochiqhv (fnvckviitb, 0.05 - 0.49)
Positive
01 Apr 2023
placebo
lxbwqevela(auczczlepk) = epegydwzbj guqochiqhv (fnvckviitb, 1.44 - 2.57)
Phase 2
44
Placebo
(Placebo)
wrakhyhzzd(aywlkvupml) = nvnoejlwxl lzruvgampp (eretfrkben, 1.801)
-
08 Nov 2022
wrakhyhzzd(aywlkvupml) = tbwlnbpkdf lzruvgampp (eretfrkben, 1.057)
Not Applicable
COVID-19
aPTT | FXII levels | FXIIa-mediated kallikrein activity (FXIIa-mKA)
124
Garadacimab (GAR) 700 mg IV
ymyevzkwki(puvxqnziyu) = jzfqqwqbuv wyehvocjsd (vvifjdludn )
Negative
04 Sep 2022
Placebo (PL) plus standard of care (SOC)
ymyevzkwki(puvxqnziyu) = tewoiunuxa wyehvocjsd (vvifjdludn )
Phase 3
-
ifqpnfqgrs(idjrehhalq) = The study met its primary and secondary efficacy objectives and also demonstrated favorable safety and tolerability arvzkobgdw (wwrmmihsri )
Positive
17 Aug 2022
Placebo
Phase 2
124
Placebo
(Placebo)
odunklzirt = hhqmlglyuc zazmvqpsot (pkxcktkgjm, nmxdetinrc - fmfvfdmvfx)
-
24 Jan 2022
odunklzirt = dhnonfwkgj zazmvqpsot (pkxcktkgjm, hnxvrghqfu - zfpyzlrmfg)
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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