Drug Type ASO |
Synonyms Mongersen (INN), Mongersen Sodium |
Target |
Action inhibitors |
Mechanism SMAD7 inhibitors(Mothers against decapentaplegic homolog 7 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (United States) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Crohn Disease | Preclinical | Austria | 08 Dec 2015 | |
Crohn Disease | Preclinical | Ukraine | 08 Dec 2015 | |
Crohn Disease | Preclinical | United States | 08 Dec 2015 | |
Crohn Disease | Preclinical | Australia | 08 Dec 2015 | |
Crohn Disease | Preclinical | Croatia | 08 Dec 2015 | |
Crohn Disease | Preclinical | Germany | 08 Dec 2015 | |
Crohn Disease | Preclinical | Greece | 08 Dec 2015 | |
Crohn Disease | Preclinical | Czechia | 08 Dec 2015 | |
Crohn Disease | Preclinical | Latvia | 08 Dec 2015 | |
Crohn Disease | Preclinical | Israel | 08 Dec 2015 |
Phase 2 | 18 | (spzvjxtjkm) = vlvxtzvjqi pefzxoncbn (tfasvbzlkm ) View more | Positive | 01 May 2021 | |||
Phase 3 | 701 | Placebo | (gfqscndxvq) = aaixaatcbk vqkzubmbxd (umcchrmlcv ) View more | Negative | 01 May 2020 | ||
(gfqscndxvq) = pgqfgblabt vqkzubmbxd (umcchrmlcv ) View more | |||||||
Phase 3 | 310 | placebo+GED-0301 (GED 40 mg 4 Weeks Alt) | nolimxotvn(vgbzxnxllb) = vnkrevizdt ehpwthrccv (wxekjrxmhk, wgnjookqdh - xrbkyixins) View more | - | 29 Jan 2019 | ||
(GED-0301 40 mg) | nolimxotvn(vgbzxnxllb) = syosxkfdli ehpwthrccv (wxekjrxmhk, nhyvxyfntd - bopydpgtie) View more | ||||||
Phase 3 | 701 | Placebo | beamgnalpw(mcyltwyvls) = jbooteryrl ndoafqkdrw (odrrqjxsug, owmcyjhmzk - lmizqlcxsn) View more | - | 23 Jan 2019 | ||
Phase 2 | 41 | (Mongersen (Weeks 0-52)) | arffrzzgpq(wvxgsiaxrx) = htxhiuijfl odagsmghyr (zczfansisc, lcxmrvycrb - aqhmfhvckv) View more | - | 12 Sep 2018 | ||
(Mongersen Total Mongersen Exposure Period) | laxihbzvsf(evsomjypxv) = qhjykedlrf idhikldple (bsmyhqhbtk, ksknluuuju - bbnyryndix) View more | ||||||
Not Applicable | - | igshjauiga(uedfixxgit) = 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) frxgznydwo (rnuolpdavq ) | - | 01 Oct 2014 | |||