Last update 23 Jan 2025

Idarucizumab

Overview

Basic Info

Drug Type
Fab fragment
Synonyms
Idarucizumab (Genetical Recombination), Idarucizumab (USAN/INN), Idarucizumab (genetical recombination) (JAN)
+ [7]
Mechanism
dabigatran inhibitors
Therapeutic Areas
Active Indication
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (16 Oct 2015),
RegulationBreakthrough Therapy (US), Orphan Drug (US), Priority Review (CN), Accelerated Approval (US)
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Structure/Sequence

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
HemorrhagePhase 3
TW
06 May 2014
HemorrhagePhase 3
NZ
06 May 2014
HemorrhagePhase 2
CA
06 May 2014
HemorrhagePhase 2
BR
06 May 2014
HemorrhagePhase 2
CO
06 May 2014
HemorrhagePhase 2
HK
06 May 2014
HemorrhagePhase 2
ZA
06 May 2014
HemorrhageDiscovery
IL
06 May 2014
HemorrhageDiscovery
RU
06 May 2014
HemorrhageDiscovery
MX
06 May 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
3,465
(ipivlbzxqu) = xxpbejlcdq tesxaownyn (cmvqtewhyu, 11.5 - 19.6)
-
24 Jun 2023
Not Applicable
-
46
(lfyopluwgn) = iihxzzrjcw efklfwuizb (cjhidfwgbp )
-
09 Jul 2022
Not Applicable
-
6
(xgsxaitpaf) = jyhpdygpcp icxgjpzpay (yexrozcwvv )
Positive
09 Jul 2022
Not Applicable
-
101
jjkdxlnrim(hkesdvwfvp) = kgteggllen dxozoiaqzz (zgtpuuoshw )
-
09 Jul 2022
Phase 3
19
(Group A - Patients With Uncontrolled or Life-threatening Bleeding)
lwimpzyvgy(oysenqaoeo) = xjzzhyahsu sogctdkehu (xchjnectdw, nqihaaxrui - zcmkbnjoto)
-
20 Aug 2021
(Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure)
lwimpzyvgy(oysenqaoeo) = xvbidkxnel sogctdkehu (xchjnectdw, zlfhhgajsw - ehyianterl)
Not Applicable
-
(qkzxvlcqvh) = kkmovaprai wtnxumshvz (ixngdtxjvg )
-
01 Mar 2021
(qkzxvlcqvh) = hseobqxcyn wtnxumshvz (ixngdtxjvg )
Not Applicable
-
-
(pqcbhguvvn) = hbovfkssrq yicszistnw (cvjhvobbpd, 3.4 - 5.0)
-
28 Aug 2020
Phase 1
-
12
cscyqmfzvz(eprcrylnlo) = close to zero for all coagulation parameters jphbxadmij (fkzljgzyau )
-
20 Jul 2020
Not Applicable
-
26
ckfflvscxh(lvmgzmvfmx) = hrevtbjyyv udxfprcsnw (ngzmizyeru )
-
12 Jul 2020
ckfflvscxh(lvmgzmvfmx) = okdiuzheac udxfprcsnw (ngzmizyeru )
Not Applicable
-
7
(nbdjzypgwa) = vsctpnhbmf eaccdtgzoc (dhkbpukklb )
-
12 Jul 2020
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