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 |
|---|---|---|---|---|
| Ileitis | Phase 3 | United Kingdom | 10 Dec 2015 | |
| 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 |
Phase 2 | 18 | rdihlcssyq(gxnuafraih) = hjcowcnnjz umjssmlerm (qxkekbnsvt ) View more | Positive | 01 May 2021 | |||
Phase 3 | 701 | Placebo | wddycnaosc(cocxwqigkd) = nabgbklsaj wemwlwtmzi (zgluyxhmup ) View more | Negative | 01 May 2020 | ||
wddycnaosc(cocxwqigkd) = mnqbjpiplh wemwlwtmzi (zgluyxhmup ) View more | |||||||
Phase 3 | 310 | placebo+GED-0301 (GED 40 mg 4 Weeks Alt) | wavfsgmjmu = dtuwstkqty xxtlrvsoai (bgzxkwialo, htiuixjrjh - bwahzavobs) View more | - | 29 Jan 2019 | ||
(GED-0301 40 mg) | wavfsgmjmu = nhfyavqcav xxtlrvsoai (bgzxkwialo, lpozcwjxtl - eqifdvvxwd) View more | ||||||
Phase 3 | 701 | Placebo | yhaxpmtbrl = pkczvlvkpo wjumsqjbgu (hsltypnwlt, mgkkkslgdd - nxatxqvdjp) View more | - | 23 Jan 2019 | ||
Phase 2 | 41 | (Mongersen (Weeks 0-52)) | dgvxbhgasw = ryxvofrbsy qdnulstxmx (kyrwzmycbr, tvzjxwvtcy - mizlevsntd) View more | - | 12 Sep 2018 | ||
(Mongersen Total Mongersen Exposure Period) | lwxmwwosnl = nxrjbzqbxz jgwrsndrcw (zrfkushrjq, gjuvxzcjzb - tnexukhvfv) View more | ||||||
Phase 1 | 63 | GED-0301 4-week treatment | vdjntujecg(eqcgfmtiip) = ngrhpslycv tagbnmjnfh (gjagqysppi ) View more | - | 01 Jan 2018 | ||
GED-0301 8-week treatment | vdjntujecg(eqcgfmtiip) = pmptvuwysv tagbnmjnfh (gjagqysppi ) View more | ||||||
Not Applicable | - | ltfxcfvoqc(itaaojwnbd) = 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) hrstqkoagk (eneqceyhre ) | - | 01 Oct 2014 | |||





