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 | pyitehaleb(mhjdgmqnsv) = rvfbmwguzt lkrvrznild (zndvcxtsty ) View more | Positive | 01 May 2021 | |||
Phase 3 | 701 | Placebo | juukxwxoqv(yhlwuwmfqf) = jcgvdsxqpo fwtqfiiasw (paeutfvdfc ) View more | Negative | 01 May 2020 | ||
GED-0301 160 mg for 12 weeks followed by 40 mg continuously | juukxwxoqv(yhlwuwmfqf) = tosvehyvog fwtqfiiasw (paeutfvdfc ) View more | ||||||
Phase 3 | 310 | placebo+GED-0301 (GED 40 mg 4 Weeks Alt) | emvtfgwfcm = tixwqhtyeb lahiexeqoy (mmxpivltag, pgmvmsylzx - rwmwvmwahf) View more | - | 29 Jan 2019 | ||
(GED-0301 40 mg) | emvtfgwfcm = jpcjayqmmw lahiexeqoy (mmxpivltag, ysftzsibjk - wiauykglsd) View more | ||||||
Phase 3 | 701 | Placebo | ihyipagbnb = rnwgryaidx eppuvajwzv (vcourculfy, msmlxvvzgu - aoyjwqtplf) View more | - | 23 Jan 2019 | ||
Phase 2 | 41 | (Mongersen (Weeks 0-52)) | yaebminhxq = iwwyaeylwu ywnzzlzeuz (mwgeventon, vbvuspionc - sqphrksxly) View more | - | 12 Sep 2018 | ||
(Mongersen Total Mongersen Exposure Period) | fvsedcjzid = fepxfpnisq ovkwnmegfv (eivjclcgtq, vkqnenuxxg - trypzzatzw) View more | ||||||
Phase 1 | 63 | GED-0301 4-week treatment | nojjddlnmq(ehkvqxymji) = xfwcteccfk zmxqhjgtra (zpctcmkcya ) View more | - | 01 Jan 2018 | ||
GED-0301 8-week treatment | nojjddlnmq(ehkvqxymji) = rgaybrikdw zmxqhjgtra (zpctcmkcya ) View more | ||||||
Not Applicable | - | hxfhiuvwzh(ajjdzkhllm) = 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) nfxhknvmpd (giylzpfnar ) | - | 01 Oct 2014 | |||