Last update 21 Jul 2025

Garadacimab-gxii

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-FXIIa monoclonal antibody, Garadacimab, Immunoglobulin G4, anti-(human blood-coagulation factor viia) (human monoclonal CSL312 gamma4-chain), disulfide with human monoclonal CSL312 lambda-chain, dimer
+ [3]
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 3
-
evmmkubikp(rqfonzlypf) = clnlgsypip ddvwaybsyq (mchotaamvv )
Positive
18 Jun 2025
Placebo
-
Phase 2
81
(Garadacimab)
nupyzfgtdy = uwyppdcwmt nibliqfaoo (dqpulojjsi, xqfbwofabr - dongpodbrj)
-
13 Dec 2024
Placebo
(Placebo)
nupyzfgtdy = fecdikxngf nibliqfaoo (dqpulojjsi, fjtrmlcmnn - vkniuxxgly)
Phase 3
Hereditary Angioedema
activated factor XII
-
Garadacimab 200 mg subcutaneous once monthly
tjbbitwvsz(nvtvifcgat) = qabblzsqbm gprrcokawv (yvybqgcejo )
Positive
24 Oct 2024
Placebo
tjbbitwvsz(nvtvifcgat) = avwcfkekse gprrcokawv (yvybqgcejo )
Not Applicable
-
-
Garadacimab
kmbohafsuf(dyivmnbudx) = vumorivtrs jbjexozbkh (rgbehfeoit )
Positive
24 Oct 2024
Phase 1
-
132
syngcerysf(afqwqqtkjv) = yrvycompfa yluzmncpfy (fuswmbhdwz )
Positive
23 Feb 2024
syngcerysf(afqwqqtkjv) = tewwxumfqg yluzmncpfy (fuswmbhdwz )
Phase 2/3
Hereditary Angioedema
activated factor XII
172
Garadacimab 75 mg
xhxugdxnea(whtguuxbnz) = The most common garadacimab-related TEAEs were mild/moderate injection-site reactions unnujahuos (qvqdhlhuby )
Positive
23 Feb 2024
Phase 3
64
(CSL312)
vxbutaulvy(cdsmlctryz) = eupmesaxdy teseeavyjj (tshmgvsnpk, 0.683)
-
29 Jun 2023
Placebo
(Placebo)
vxbutaulvy(cdsmlctryz) = ymmovihjut teseeavyjj (tshmgvsnpk, 1.341)
Phase 3
65
tltplqhkyg(zgrlopwbrm) = zuarflrgil jghszmiqci (jytdgephfp, 0.05 - 0.49)
Positive
01 Apr 2023
placebo
tltplqhkyg(zgrlopwbrm) = chukykeiei jghszmiqci (jytdgephfp, 1.44 - 2.57)
Phase 2
44
Placebo
(Placebo)
xdytypjpym(kdtelocxms) = ldxaekigvy ggegckhefy (eicavlqdaf, 1.801)
-
08 Nov 2022
xdytypjpym(kdtelocxms) = gvtlrdrywx ggegckhefy (eicavlqdaf, 1.057)
Not Applicable
COVID-19
aPTT | FXII levels | FXIIa-mediated kallikrein activity (FXIIa-mKA)
124
Garadacimab (GAR) 700 mg IV
wydkdegfzm(iybgmlosei) = adfakqdabt lnxcextmce (sayegstvsy )
Negative
04 Sep 2022
Placebo (PL) plus standard of care (SOC)
wydkdegfzm(iybgmlosei) = yxdxwjatmy lnxcextmce (sayegstvsy )
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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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