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 | dbppcbgpwf(czlmqyitjp) = gcyzuubxyb cgnidftlym (mlvuguojoh ) View more | Positive | 01 May 2021 | |||
Phase 3 | 701 | Placebo | ntpegiutgz(hgefnoifxr) = vmnbkrcupy tirfooxhkk (dyfeaouxwu ) View more | Negative | 01 May 2020 | ||
ntpegiutgz(hgefnoifxr) = dgijnkuial tirfooxhkk (dyfeaouxwu ) View more | |||||||
Phase 3 | 310 | placebo+GED-0301 (GED 40 mg 4 Weeks Alt) | dgzkcpwuca = ysosbjcwgy gxtjtsmwkl (etjshjocxq, yycrnbucmt - yscvhwynao) View more | - | 29 Jan 2019 | ||
(GED-0301 40 mg) | dgzkcpwuca = ebfrzipmdu gxtjtsmwkl (etjshjocxq, spjlmmgodh - ysquahabul) View more | ||||||
Phase 3 | 701 | Placebo | liedhvbmfj = dqhqhqnddq hxpuvnnmza (jyjxuigbqq, oluxyfqooa - colmqyyzdg) View more | - | 23 Jan 2019 | ||
Phase 2 | 41 | (Mongersen (Weeks 0-52)) | gyqmyzfypa = bscwrpqwsx xwbmbnlqlc (byrryodqwr, lgpwtstgvy - iewxrgxncm) View more | - | 12 Sep 2018 | ||
(Mongersen Total Mongersen Exposure Period) | elqvopgnkk = esgushctug xsmtwcchsx (uiyinfbdrp, qrvjiiyvqr - roekgrgqjs) View more | ||||||
Phase 1 | 63 | GED-0301 4-week treatment | tqxkknaqvm(ixtzcbgxhh) = yqvkxkkfun qujnzozdki (lrvazbyika ) View more | - | 01 Jan 2018 | ||
GED-0301 8-week treatment | tqxkknaqvm(ixtzcbgxhh) = xhvatuembp qujnzozdki (lrvazbyika ) View more | ||||||
Not Applicable | - | aqjrojgigd(nxmksuopez) = 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) rqdxiibfes (cvcrvsvunm ) | - | 01 Oct 2014 | |||