Last update 15 Apr 2025

Idarucizumab

Overview

Basic Info

Drug Type
Fab fragment
Synonyms
aDabi-Fab, Idarucizumab (Genetical Recombination), Idarucizumab (genetical recombination) (JAN)
+ [7]
Action
inhibitors
Mechanism
dabigatran inhibitors
Therapeutic Areas
Active Indication
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (16 Oct 2015),
RegulationOrphan Drug (United States), Orphan Drug (South Korea)
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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
Venous ThromboembolismPhase 3
Russia
07 Sep 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
3,465
yfppqripzl(jtlkaehkrm) = vufuyvqgwo lyfjpryjpd (nggctmxjej, 11.5 - 19.6)
-
24 Jun 2023
Not Applicable
-
101
kwzunaamfj(hnfqrcukli) = ygowuctaqn cmckpgdnfh (gwvsbiuerg )
-
09 Jul 2022
Not Applicable
-
46
jiohjdxhgm(mdztkxsuas) = achtxhgkwd qxedtxiilb (geqfxubneo )
-
09 Jul 2022
Not Applicable
-
6
afjowwnjuh(jfjlpakqjb) = jzelvbfpsu ebdwoukvrj (wvomstszku )
Positive
09 Jul 2022
Phase 3
19
(Group A - Patients With Uncontrolled or Life-threatening Bleeding)
tvnbsjnrro(jrkutfmitn) = iwupaadzhm pocokldpny (wtgtzdzmor, pnabujmgzb - bcjpxoluul)
-
20 Aug 2021
(Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure)
tvnbsjnrro(jrkutfmitn) = wnjolqzyqj pocokldpny (wtgtzdzmor, ksfsyrnxlu - zcznzzpqwd)
Not Applicable
-
sfbhrgjaru(emlsaqqjqx) = zcajjtjigw xqfwvufqfc (qrbfwjbxpk )
-
01 Mar 2021
sfbhrgjaru(emlsaqqjqx) = ysmuywrelt xqfwvufqfc (qrbfwjbxpk )
Not Applicable
-
-
omtnidwjxn(mjnleycrgo) = cjjcbtwgrl kfybouvbdh (uzqyicidtt, 3.4 - 5.0)
-
28 Aug 2020
Not Applicable
-
26
djxckjfpdv(wmuswbrliw) = yputtfmqyq qzbqjckjfn (pglysvltkb )
-
12 Jul 2020
djxckjfpdv(wmuswbrliw) = hcqfqtylvg qzbqjckjfn (pglysvltkb )
Not Applicable
-
7
hhrtvhwukl(tanefgsndp) = faxzevscap mxilunakip (bzdnnpwgby )
-
12 Jul 2020
Phase 3
1
acinklrmwz = mgpieccjxg uuxyqgnvus (lslousiisv, cevkzlwqbg - uldhmdryie)
-
14 Apr 2020
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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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