Last update 29 Nov 2024

Denecimig

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
Coagulation factor VIII mimetic antibody, FVIII mimetic antibody, MIM 8
+ [5]
Mechanism
F10 inhibitors(Coagulation factor X inhibitors), factor IXa inhibitors(Factor IXa inhibitors)
Active Indication
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hemophilia APhase 3
US
02 Dec 2021
Hemophilia APhase 3
CN
02 Dec 2021
Hemophilia APhase 3
JP
02 Dec 2021
Hemophilia APhase 3
AT
02 Dec 2021
Hemophilia APhase 3
BE
02 Dec 2021
Hemophilia APhase 3
CA
02 Dec 2021
Hemophilia APhase 3
CZ
02 Dec 2021
Hemophilia APhase 3
DK
02 Dec 2021
Hemophilia APhase 3
FR
02 Dec 2021
Hemophilia APhase 3
DE
02 Dec 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
254
Mim8 once-weekly prophylaxis
(no prior prophylaxis treatment)
pbonkkqlvv(hlctxlujud) = zdxrcymyyk rfshkiaymb (urpwphuxvh )
Positive
23 Jun 2024
Mim8 once-monthly prophylaxis
(no prior prophylaxis treatment)
pbonkkqlvv(hlctxlujud) = vsewndeneh rfshkiaymb (urpwphuxvh )
Phase 3
254
Mim8 once-weekly
ddumfcxduh(avzlszcuki) = wbtvsutvgq jwgznrntoo (wwjqvlvtjw )
Met
Positive
13 May 2024
Mim8 once-monthly
ddumfcxduh(avzlszcuki) = nbksiefhdz jwgznrntoo (wwjqvlvtjw )
Met
Not Applicable
-
byhyzqypiy(pybycgwiyg) = acnqhgpwwq qopwvuzjyy (ctpporfwsn )
-
10 Dec 2023
Phase 1/2
42
gwmtqatrkv(mvwpybpfnt) = enryofsxey fwcxrsvhdj (nfwmdnkqpq )
Positive
15 Nov 2022
Phase 1/2
-
-
(SAD phase)
aqfiahnrvm(cijlwitoaa) = Mim8 was well tolerated following both single and multiple dosing, and no thromboembolic events or related serious adverse events were reported dstfgyslpo (lvwqyjpwye )
Positive
11 Jul 2022
(MAD phase)
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Regulation

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