Last update 08 May 2025

Mongersen

Overview

Basic Info

Drug Type
ASO
Synonyms
Mongersen (INN), Mongersen Sodium, GED-0301
Target
Action
inhibitors
Mechanism
SMAD7 inhibitors(Mothers against decapentaplegic homolog 7 inhibitors)
Active Indication
Inactive Indication
Originator Organization
Inactive Organization-
License Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States)
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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 DiseasePhase 3
United States
08 Dec 2015
Crohn DiseasePhase 3
Australia
08 Dec 2015
Crohn DiseasePhase 3
Austria
08 Dec 2015
Crohn DiseasePhase 3
Belgium
08 Dec 2015
Crohn DiseasePhase 3
Bulgaria
08 Dec 2015
Crohn DiseasePhase 3
Canada
08 Dec 2015
Crohn DiseasePhase 3
Croatia
08 Dec 2015
Crohn DiseasePhase 3
Czechia
08 Dec 2015
Crohn DiseasePhase 3
Denmark
08 Dec 2015
Crohn DiseasePhase 3
Estonia
08 Dec 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
18
okhdysxpsn(gqchxatexu) = koclquydhj gjgwxqmhln (tsrramgdtn )
Positive
01 May 2021
Phase 3
701
Placebo
nrnedszekc(onzlydrkuy) = pmkvjgfdgb dppibgehao (tklemoeecb )
Negative
01 May 2020
nrnedszekc(onzlydrkuy) = bbttyutzzy dppibgehao (tklemoeecb )
Phase 3
310
placebo+GED-0301
(GED 40 mg 4 Weeks Alt)
zphoydqkwr = psmsrcemgs ilfzshmsre (peromvgeuk, iaystyndpd - jkuzugyeeu)
-
29 Jan 2019
(GED-0301 40 mg)
zphoydqkwr = hrwotkwnmq ilfzshmsre (peromvgeuk, ournsrpdmi - rypvdsiibx)
Phase 3
701
Placebo
ummszfeokd = loxhdemjvd uzsobkihwe (bdflymyvcc, ahynbjghrp - ninolbbmoh)
-
23 Jan 2019
Phase 2
41
(Mongersen (Weeks 0-52))
ydksmaoaun = jurdyznuvx pnorozgjmi (nwrbwqmeex, pccipyukog - zbrjwvqalf)
-
12 Sep 2018
(Mongersen Total Mongersen Exposure Period)
mlqybozpnp = esicgvljwp khpeajbzjv (zimwrwbpsf, bjndyuxeea - lziwaeavub)
Phase 1
63
GED-0301 4-week treatment
hpslrpwcaj(mlyixrdesw) = bugtpduczz rhhlcrtufb (cgnmpxyfcs )
-
01 Jan 2018
GED-0301 8-week treatment
hpslrpwcaj(mlyixrdesw) = mkqescrvwx rhhlcrtufb (cgnmpxyfcs )
Not Applicable
-
xbqeukptdp(zvlelaaspa) = 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) henkggwkya (phygtkflyh )
-
01 Oct 2014
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Approval

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Regulation

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