Last update 23 Jan 2025

Mongersen

Overview

Basic Info

Drug Type
ASO
Synonyms
Mongersen (INN), Mongersen Sodium
Target
Mechanism
SMAD7 inhibitors(Mothers against decapentaplegic homolog 7 inhibitors)
Active Indication
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (US)
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Structure/Sequence

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External Link

KEGGWikiATCDrug Bank
D10956--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Crohn DiseaseNDA/BLA
UA
08 Dec 2015
Crohn DiseaseNDA/BLA
NO
08 Dec 2015
Crohn DiseaseNDA/BLA
BG
08 Dec 2015
Crohn DiseaseNDA/BLA
TR
08 Dec 2015
Crohn DiseaseNDA/BLA
CH
08 Dec 2015
Crohn DiseaseNDA/BLA
EE
08 Dec 2015
Crohn DiseaseIND Application
PL
08 Dec 2015
Crohn DiseaseIND Application
RS
08 Dec 2015
Crohn DiseaseDiscovery
ES
08 Dec 2015
Crohn DiseaseDiscovery
BE
08 Dec 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
18
(nylzkqrlir) = gwkixtkvgw oiuzbvbpuv (kayxhldrwe )
Positive
01 May 2021
Phase 3
310
placebo+GED-0301
(GED 40 mg 4 Weeks Alt)
ycgjxkxsgz(sspzojcpzo) = xhqqhasoig fwcqyfprai (mrqbdphibf, qkmzmkutqi - jlfadfqjar)
-
29 Jan 2019
(GED-0301 40 mg)
ycgjxkxsgz(sspzojcpzo) = aczhnaqfzc fwcqyfprai (mrqbdphibf, wdbqiqsxga - gzeybmriui)
Phase 3
701
Placebo
hopxlblmsl(xwouphphlk) = tpdyipajci utbecjrckp (ycqepyfhqo, cwegtqhlbp - znrzizhimi)
-
23 Jan 2019
Phase 2
41
(Mongersen (Weeks 0-52))
pugkmbhdto(bnahgkadpg) = ysgkcluabu mznxmbqmip (zusdwenbjm, htghzmvuai - kyakmydzsj)
-
12 Sep 2018
(Mongersen Total Mongersen Exposure Period)
gbbqoxotxr(xxgyuhknzb) = fubthcreya prjhgtwfsp (eebxcuclmf, wqygjswbqi - gzjlzigwui)
Not Applicable
-
pgqaiosqjl(jjaeswlesg) = The rates of adverse events (AEs) and serious AEs (SAEs) were similar across groups. Nine SAEs occurred in 6 patients (placebo, n=1; Mongersen 10 mg, n=3; 40 mg, n=1; 160 mg, n=1). Most SAEs consisted of hospital admissions for CD-associated complications or symptoms, and included: pyrexia and cough (placebo); abdominal pain (n=2), CD worsening and pyrexia (Mongersen 10 mg); seton placement for perianal fistula and surgery for hemorrhoid thrombosis (Mongersen 40 mg); and thermal burn (Mongersen 160 mg) dycbitfhlc (lidpjxyxhx )
-
01 Oct 2014
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Clinical Trial

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Regulation

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