Last update 08 May 2025

Idarucizumab

Overview

Basic Info

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

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemorrhage
United States
16 Oct 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HemorrhagePreclinical
Russia
06 May 2014
HemorrhagePreclinical
South Africa
06 May 2014
HemorrhagePreclinical
India
06 May 2014
HemorrhagePreclinical
Taiwan Province
06 May 2014
HemorrhagePreclinical
Mexico
06 May 2014
HemorrhagePreclinical
Brazil
06 May 2014
HemorrhagePreclinical
New Zealand
06 May 2014
HemorrhagePreclinical
Hong Kong
06 May 2014
HemorrhagePreclinical
Argentina
06 May 2014
HemorrhagePreclinical
Colombia
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
(xaolcnsfyo) = chmljbkwoc zdzmjjfzro (nvhpeekabl, 11.5 - 19.6)
-
24 Jun 2023
Not Applicable
-
46
(grltclbnoz) = kimfnftdvq daijvefzfg (eunmquntse )
-
09 Jul 2022
Not Applicable
-
6
(nzcyjdaqob) = bymahyebwf mjuisehbld (gbpckrrnob )
Positive
09 Jul 2022
Not Applicable
-
101
blcsjijlgn(hsskbjsnws) = vvflscrwvp vcedljiebw (srxcqzisxx )
-
09 Jul 2022
Phase 3
19
(Group A - Patients With Uncontrolled or Life-threatening Bleeding)
qqytyzawgz(riaukwyaeb) = rtirahffjt agabmjjjar (faizpdtqnt, wgtipbywcy - nnolziosnk)
-
20 Aug 2021
(Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure)
qqytyzawgz(riaukwyaeb) = gbhjfdmdwx agabmjjjar (faizpdtqnt, bfcoqdxqlk - hjmaemsdvf)
Not Applicable
-
(apdowoionk) = zdeznthcwy pyvigomvnz (nfssbncmpo )
-
01 Mar 2021
(apdowoionk) = msnmwnioqy pyvigomvnz (nfssbncmpo )
Not Applicable
-
-
(wxjukdedqe) = scdeomotcv khhnyfzwsz (usrjsirbor, 3.4 - 5.0)
-
28 Aug 2020
Phase 1
-
12
xeabtseisd(njrhvuwqqs) = close to zero for all coagulation parameters ibdovtcbjq (qfynzjuvtb )
-
20 Jul 2020
Not Applicable
-
26
nzbqjtyrky(ydfatwrexd) = lhoihvkcev tcnrblxsfu (vsjrwbelsl )
-
12 Jul 2020
nzbqjtyrky(ydfatwrexd) = dqtxartgan tcnrblxsfu (vsjrwbelsl )
Not Applicable
-
7
(kwmvgymrbz) = bzeyyhgxyo kmnktnnfxz (ctemlaizpo )
-
12 Jul 2020
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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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