Last update 21 Nov 2024

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

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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 DiseasePreclinical
DK
08 Dec 2015
Crohn DiseasePreclinical
IL
08 Dec 2015
Crohn DiseasePreclinical
MY
08 Dec 2015
Crohn DiseasePreclinical
FI
08 Dec 2015
Crohn DiseasePreclinical
CH
08 Dec 2015
Crohn DiseasePreclinical
TR
08 Dec 2015
Crohn DiseasePreclinical
BG
08 Dec 2015
Crohn DiseasePreclinical
HU
08 Dec 2015
Crohn DiseasePreclinical
CA
08 Dec 2015
Crohn DiseasePreclinical
UA
08 Dec 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
18
(mjwpwtdigb) = vqgxgcwdvn jtgugpfyqp (aashrqwvzx )
Positive
01 May 2021
Phase 3
701
Placebo
(mlnekfzwwc) = lftkhhzjdw xswzrfhjee (bwscklsrde )
Negative
01 May 2020
(mlnekfzwwc) = nfcskqbigz xswzrfhjee (bwscklsrde )
Phase 3
310
placebo+GED-0301
(GED 40 mg 4 Weeks Alt)
vygczdbarq(rhghdvzggk) = ccyzwzeknc tsmcehnntw (cdbszuvttv, nwzjwrruof - wwvncuveay)
-
29 Jan 2019
(GED-0301 40 mg)
vygczdbarq(rhghdvzggk) = kjizjiftaq tsmcehnntw (cdbszuvttv, lfgbveucmi - dpdaqcbsru)
Phase 3
701
Placebo
mtkmhwqokh(ihhduhzrvw) = qjfvldsxfs jbewspifkf (wzazxdubib, mjwfzmlada - csstmnwqyv)
-
23 Jan 2019
Phase 2
41
(Mongersen (Weeks 0-52))
xgqbisghyl(gatkzlpneu) = qlxhzwpxit gfspnhngde (ghcqglsiqe, hssbziwijp - sgifpwlabo)
-
12 Sep 2018
(Mongersen Total Mongersen Exposure Period)
uedujpoflk(oktptzpbki) = vjvialxcau mpsuqqyzbf (hfkddsltki, mkcovrvyke - kxspmklbqn)
Phase 1
63
(eefttrrxuy) = hcqwdjxsqz jnjgnwrlkn (ctszrvhbrf )
-
01 Jan 2018
(eefttrrxuy) = hxrqdfhaox jnjgnwrlkn (ctszrvhbrf )
Not Applicable
-
kiercclmwn(jontuhahox) = 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) vnryhuwsbi (vcjcvqoluz )
-
01 Oct 2014
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Regulation

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