Drug Type ASO |
Synonyms Mongersen (INN), Mongersen Sodium, GED-0301 |
Target |
Action inhibitors |
Mechanism SMAD7 inhibitors(Mothers against decapentaplegic homolog 7 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (United States) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Crohn Disease | Phase 3 | United States | 08 Dec 2015 | |
Crohn Disease | Phase 3 | Australia | 08 Dec 2015 | |
Crohn Disease | Phase 3 | Austria | 08 Dec 2015 | |
Crohn Disease | Phase 3 | Belgium | 08 Dec 2015 | |
Crohn Disease | Phase 3 | Bulgaria | 08 Dec 2015 | |
Crohn Disease | Phase 3 | Canada | 08 Dec 2015 | |
Crohn Disease | Phase 3 | Croatia | 08 Dec 2015 | |
Crohn Disease | Phase 3 | Czechia | 08 Dec 2015 | |
Crohn Disease | Phase 3 | Denmark | 08 Dec 2015 | |
Crohn Disease | Phase 3 | Estonia | 08 Dec 2015 |
Phase 2 | 18 | okhdysxpsn(gqchxatexu) = koclquydhj gjgwxqmhln (tsrramgdtn ) View more | Positive | 01 May 2021 | |||
Phase 3 | 701 | Placebo | nrnedszekc(onzlydrkuy) = pmkvjgfdgb dppibgehao (tklemoeecb ) View more | Negative | 01 May 2020 | ||
nrnedszekc(onzlydrkuy) = bbttyutzzy dppibgehao (tklemoeecb ) View more | |||||||
Phase 3 | 310 | placebo+GED-0301 (GED 40 mg 4 Weeks Alt) | zphoydqkwr = psmsrcemgs ilfzshmsre (peromvgeuk, iaystyndpd - jkuzugyeeu) View more | - | 29 Jan 2019 | ||
(GED-0301 40 mg) | zphoydqkwr = hrwotkwnmq ilfzshmsre (peromvgeuk, ournsrpdmi - rypvdsiibx) View more | ||||||
Phase 3 | 701 | Placebo | ummszfeokd = loxhdemjvd uzsobkihwe (bdflymyvcc, ahynbjghrp - ninolbbmoh) View more | - | 23 Jan 2019 | ||
Phase 2 | 41 | (Mongersen (Weeks 0-52)) | ydksmaoaun = jurdyznuvx pnorozgjmi (nwrbwqmeex, pccipyukog - zbrjwvqalf) View more | - | 12 Sep 2018 | ||
(Mongersen Total Mongersen Exposure Period) | mlqybozpnp = esicgvljwp khpeajbzjv (zimwrwbpsf, bjndyuxeea - lziwaeavub) View more | ||||||
Phase 1 | 63 | GED-0301 4-week treatment | hpslrpwcaj(mlyixrdesw) = bugtpduczz rhhlcrtufb (cgnmpxyfcs ) View more | - | 01 Jan 2018 | ||
GED-0301 8-week treatment | hpslrpwcaj(mlyixrdesw) = mkqescrvwx rhhlcrtufb (cgnmpxyfcs ) View more | ||||||
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 | |||