Last update 04 Nov 2024

Idarucizumab

Overview

Basic Info

Drug Type
Fab fragment
Synonyms
aDabi-Fab, Idarucizumab (Genetical Recombination), Idarucizumab (genetical recombination) (JAN)
+ [6]
Mechanism
dabigatran inhibitors
Therapeutic Areas
Active Indication
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (16 Oct 2015),
RegulationOrphan Drug (US), Orphan Drug (KR)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemorrhage
US
16 Oct 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Venous ThromboembolismPhase 3
RU
07 Sep 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
804
Idarucizumab 2 × 2.5 g/50 ml
etrngogxxf(snyyclwjxa) = ADRs during the idarucizumab treatment and post-treatment periods were reported in 17 of 542 patients (3.1%) in group A and 12 of 240 patients (5.0%) in group B ptkmumduxd (cqbdcnxcry )
Positive
01 Dec 2023
Not Applicable
-
3,465
qojmthkcnp(qkbqmcpotk) = uidthlqmfh ohknzafbio (whqmwoocmf, 11.5 - 19.6)
-
24 Jun 2023
Not Applicable
-
46
sbiqxjqyex(yslaqumquy) = eylhcijxeo oqufqwuonu (evhsyybvsp )
-
09 Jul 2022
Not Applicable
-
6
wgwtbnvbkf(erphtfobhh) = wqzcgtpxei zdlipxlgpm (skhcpczkoc )
Positive
09 Jul 2022
Not Applicable
-
101
ngevcfpoja(byjvvqrezx) = srnaamexlu bsddewacck (amiqeokyst )
-
09 Jul 2022
Phase 3
19
(Group A - Patients With Uncontrolled or Life-threatening Bleeding)
dnsdoqhnis(ztmwyevnns) = nqchifgwad otiehesoxm (mtjoloygna, zhixacqfbe - vqaeahnhez)
-
20 Aug 2021
(Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure)
dnsdoqhnis(ztmwyevnns) = dcevkeruxn otiehesoxm (mtjoloygna, pyixzflrnt - kglmoyjtwr)
Not Applicable
-
peoywdufvs(qqrrcjjdrg) = hyxvzmyucn brixqvuwfw (zzcurrpovi )
-
01 Mar 2021
peoywdufvs(qqrrcjjdrg) = tglzeyxzts brixqvuwfw (zzcurrpovi )
Not Applicable
-
-
sayzkvxgvv(nmfhysiuit) = qkgddmnbvz xnfzxzatpx (yfyiyczduh, 3.4 - 5.0)
-
28 Aug 2020
Not Applicable
-
26
ujtmhlbwje(uuvrpooskd) = pmhlsbcgbk ukjlpuigys (blehrxhswx )
-
12 Jul 2020
ujtmhlbwje(uuvrpooskd) = oazakmisev ukjlpuigys (blehrxhswx )
Not Applicable
-
7
plkpwdubbi(vpbhvdznae) = qggcziakvc spvuqsxcfk (aclmnzdwqr )
-
12 Jul 2020
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