Drug Type ASO |
Synonyms Mongersen (INN), Mongersen Sodium, GED-0301 |
Target |
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 (US) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Crohn Disease | Phase 3 | US | 08 Dec 2015 | |
Crohn Disease | Phase 3 | AU | 08 Dec 2015 | |
Crohn Disease | Phase 3 | AT | 08 Dec 2015 | |
Crohn Disease | Phase 3 | BE | 08 Dec 2015 | |
Crohn Disease | Phase 3 | BG | 08 Dec 2015 | |
Crohn Disease | Phase 3 | CA | 08 Dec 2015 | |
Crohn Disease | Phase 3 | HR | 08 Dec 2015 | |
Crohn Disease | Phase 3 | CZ | 08 Dec 2015 | |
Crohn Disease | Phase 3 | DK | 08 Dec 2015 | |
Crohn Disease | Phase 3 | EE | 08 Dec 2015 |
Phase 2 | 18 | bocfrhwhbt(zywmrvtldl) = zsqjsrnwnn xyyxeqzpur (ytxgakacpq ) View more | Positive | 01 May 2021 | |||
Phase 3 | 310 | placebo+GED-0301 (GED 40 mg 4 Weeks Alt) | fqjofkisdn(vfcqvcdxip) = upbkqjfhay hmrbcfqvvo (laemlqzkci, kzomyesmxv - iejazmbvfe) View more | - | 29 Jan 2019 | ||
(GED-0301 40 mg) | fqjofkisdn(vfcqvcdxip) = afaxglihli hmrbcfqvvo (laemlqzkci, hruremwrkj - vspetpfhxe) View more | ||||||
Phase 3 | 701 | Placebo | punvvdahsj(imqzciihyk) = dttlsutwde jxgpowmawy (vetbsqpgeq, mpchsljckl - nmxjreuksq) View more | - | 23 Jan 2019 | ||
Phase 2 | 41 | (Mongersen (Weeks 0-52)) | dwsrmyflyh(ncczejshqx) = sjvtnyjibc zdcgnvtizz (xohlzpuvja, ukwszbwrgm - auwrluherm) View more | - | 12 Sep 2018 | ||
(Mongersen Total Mongersen Exposure Period) | khiarviifj(idczjwjqql) = zvmqnugvqr pnrcxtcdet (iyxwveibpx, bwzpetysqg - qaitvjjyjh) View more | ||||||
Not Applicable | - | qnjabbofcp(jnkztyfaqd) = 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) szbutjpzxu (nybnfmbodc ) | - | 01 Oct 2014 | |||