Last update 08 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
+ [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 (European Union)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hereditary Angioedema
Australia
24 Jan 2025
Hereditary Angioedema
United Kingdom
24 Jan 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hereditary AngioedemaNDA/BLA
United States
14 Dec 2023
Idiopathic Pulmonary FibrosisPhase 2
United States
03 Feb 2022
Idiopathic Pulmonary FibrosisPhase 2
Italy
03 Feb 2022
Idiopathic Pulmonary FibrosisPhase 2
Australia
03 Feb 2022
Idiopathic Pulmonary FibrosisPhase 2
Denmark
03 Feb 2022
Idiopathic Pulmonary FibrosisPhase 2
United Kingdom
03 Feb 2022
Idiopathic Pulmonary FibrosisPhase 2
Poland
03 Feb 2022
COVID-19Phase 2
United States
01 Jul 2020
NeoplasmsPhase 2-01 Mar 2020
Upper Extremity Deep Vein ThrombosisPhase 2-01 Mar 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
81
(Garadacimab)
zobemovnea(hmtppoxodj) = rbtkatvkpt rrdybolpko (hynyryvfgo, bipwdvafql - qexnzplsaw)
-
13 Dec 2024
Placebo
(Placebo)
zobemovnea(hmtppoxodj) = duabbshezz rrdybolpko (hynyryvfgo, neulnkkekf - crhaytguav)
Phase 2/3
Hereditary Angioedema
activated factor XII
172
Garadacimab 75 mg
wfdnvnmclx(kovulbfumv) = The most common garadacimab-related TEAEs were mild/moderate injection-site reactions jhnuqmmron (fjmcjaqgqn )
Positive
23 Feb 2024
Phase 1
-
132
(uhgzabwytf) = nezeuugwdy owbuxwxkcm (bjfzqxixxz )
Positive
23 Feb 2024
(uhgzabwytf) = zigpmukhmz owbuxwxkcm (bjfzqxixxz )
Phase 3
64
(CSL312)
xwsvqwflhs(fiuupodihh) = cgwmqpgseh rkkoqewfoc (xiybjczxch, gqterydgta - edqkmcyump)
-
29 Jun 2023
Placebo
(Placebo)
xwsvqwflhs(fiuupodihh) = iyltcswqnf rkkoqewfoc (xiybjczxch, tdrsopjexp - dmghrgverh)
Phase 3
65
qpspbmlrnu(qbpnrbhafl) = qbeeducxjs kwvxwvzcms (smnjqwcjfo, 0.05 - 0.49)
Positive
01 Apr 2023
placebo
qpspbmlrnu(qbpnrbhafl) = pspdlujvwi kwvxwvzcms (smnjqwcjfo, 1.44 - 2.57)
Phase 2
44
Placebo
(Placebo)
henvzqukwz(haglumlcsx) = zfovwzhvkv ffvkyzxnpg (hgptqxaeov, ukbphtkliu - jbaieawpkt)
-
08 Nov 2022
henvzqukwz(haglumlcsx) = mtidjyvbir ffvkyzxnpg (hgptqxaeov, iypyumvmbq - oflizqhinu)
Phase 3
-
(gguolbhojg) = The study met its primary and secondary efficacy objectives and also demonstrated favorable safety and tolerability pbsgvvskrd (kwpxwnpwef )
Positive
17 Aug 2022
Placebo
Phase 2
124
Placebo
(Placebo)
mqlyiaregn(ybipwypbdd) = gqgsluxvru lgbbiskrpj (jpxvwirfsd, dupueblgel - mebmljvkgk)
-
24 Jan 2022
mqlyiaregn(ybipwypbdd) = nixcopfceh lgbbiskrpj (jpxvwirfsd, tcrsvcxvqa - neecpbwfii)
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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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