| Drug ID: | Drug164 |
|---|---|
| Drug Name: | GED-0301 |
| CID: | 121490254 |
| DrugBank ID: | NULL |
| Modality: | Small Molecule |
| Groups: | NULL |
| US Approved: | NULL |
| Other Approved: | NULL |
| Identifier: | NCT02601300, , NCT02596893 |
| Molecular Formula: | C200H261N69O107P20S20 |
| Molecular Weight: | 6604.0 g/mol |
| Isomeric SMILES: | CC1=CN(C(=O)NC1=O)[C@H]2C[C@@H]([C@H](O2)COP(=S)(O)O[C@H]3C[C@@H](O[C@@H]3CO)N4C=NC5=C4N=C(NC5=O)N)OP(=S)(O)OC[C@@H]6[C@H](C[C@@H](O6)N7C=C(C(=NC7=O)N)C)OP(=S)(O)OC[C@@H]8[C@H](C[C@@H](O8)N9C=NC1=C9N=C(NC1=O)N)OP(=S)(O)OC[C@@H]1[C@H](C[C@@H](O1)N1C=CC(=NC |
| Synonyms: | mongersen; 1443994-46-4; UNII-O1VIU3R1NE; O1VIU3R1NE; DNA, d(P-thio)(G-T-m5C-G-C-C-C-C-T-T-C-T-C-C-C-m5C-G-C-A-G-C); GED-0301; GTPL8277; GED0301; DA-75665 |
| Phase 0: | 0 |
| Phase 1: | 0 |
| Phase 2: | 0 |
| Phase 3: | 0 |
| Phase 4: | 0 |
| Description: | NULL |
Molecular Structure
No molecular structure data available
Knowledge Graph
| dtID | CID | Compound Name | Gene ID | Gene Name | Species | PubMed IDs | Action |
|---|---|---|---|---|---|---|---|
| No data available | |||||||
- No data available
Phase Distribution
Phase Description
- Phase 0: Exploratory trials to assess drug behavior in humans
- Phase 1: Safety trials to determine safe dosage range
- Phase 2: Efficacy trials to evaluate therapeutic effects
- Phase 3: Large-scale trials to confirm efficacy and safety
- Phase 4: Post-marketing surveillance for long-term safety and efficacy
| Trial ID | Title | Phase | Status | Sponsor | Indications | Interventions | |
|---|---|---|---|---|---|---|---|
| NCT02974322 | A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease | PHASE3 | WITHDRAWN | Celgene | Crohn Disease | DRUG: GED-0301|DRUG: Placebo | Details |
| NCT02685683 | Pharmacodynamic and Clinical Outcome Study of Mongersen in Patients With Crohn's Disease | PHASE2 | TERMINATED | Celgene | Crohn's Disease | DRUG: GED-0301 | Details |
| NCT02641392 | A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease | PHASE3 | TERMINATED | Celgene | Crohn's Disease | DRUG: GED-0301|OTHER: Placebo | Details |
| NCT02601300 | An Efficacy and Safety Study of Mongersen (GED-0301) in Subjects With Active Ulcerative Colitis | PHASE2 | COMPLETED | Celgene | Colitis, Ulcerative | DRUG: GED-0301 | Details |
| NCT02596893 | Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease | PHASE3 | TERMINATED | Celgene | Crohn Disease | DRUG: GED-0301|DRUG: Placebo | Details |
| NCT02367183 | A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease | PHASE1 | COMPLETED | Celgene | Crohn Disease | DRUG: GED-0301|DRUG: Placebo | Details |
| NCT03467841 | Cytomegalovirus Infection in Steroid-refractory Ulcerative Colitis | NULL | UNKNOWN | Dr mohammedRmadan hamad | Cmv Colitis | DEVICE: CMV IgM, IgG in blood real time PCR for s… | Details |
| NCT03272152 | Comprehensive DNA Methylation Profiling in Crohn's Disease | NULL | UNKNOWN | Jinling Hospital, China | Crohn Disease|Methylation|Illumina Human Methylat… | GENETIC: Genome-wide DNA methylation | Details |
| NCT03266068 | Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders | NULL | COMPLETED | Mayo Clinic | Campylobacter Infections|Irritable Bowel Syndrome | GENETIC: DNA Analysis of Blood Sample|PROCEDURE: … | Details |
| NCT03172195 | Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up | NA | TERMINATED | Centre Hospitalier Universitaire de Saint Etienne | Colitis, Ulcerative | PROCEDURE: rectosigmoidoscopy|BIOLOGICAL: biopsie… | Details |
| NCT02984059 | Study Assessing Risk Factors for Abdominal Pain in Children With Inflammatory Bowel Disease | NULL | COMPLETED | Connecticut Children's Medical Center | Inflammatory Bowel Disease | GENETIC: Genomic DNA|GENETIC: RNA analysis|GENETI… | Details |
| NCT02503696 | Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD) | NULL | COMPLETED | Exact Sciences Corporation | Inflammatory Bowel Disease|Colorectal Neoplasms|D… | DEVICE: Stool Collection Kit | Details |
| NCT02128503 | Prevalence and Clinical Course of Chronic Hep B Infection in IBD and Rheumatologic Disease | NA | TERMINATED | Chinese University of Hong Kong | Inflammatory Bowel Disease|Crohn Disease|Ulcerati… | OTHER: HBV DNA level monitoring | Details |
| NCT01860963 | Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls | NA | COMPLETED | Stanford University | Anal Squamous Intraepithelial Lesion (ASIL)|HPV D… | PROCEDURE: Anal Pap smear and HPV DNA testing | Details |
| NCT01819766 | Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease | NULL | COMPLETED | Exact Sciences Corporation | Inflammatory Bowel Disease (IBD)|Primary Sclerosi… | None | Details |
| NCT01793168 | Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford | NULL | RECRUITING | Sanford Health | Rare Disorders|Undiagnosed Disorders|Disorders of… | None | Details |
| NCT01653054 | Anal Dysplasia in Patients With Inflammatory Bowel Disease | NA | COMPLETED | Montefiore Medical Center | IBD | PROCEDURE: Anal Pap Smear, HPV DNA Testing | Details |
| NCT01028898 | Abnormal Expression Proteins, Mitochondrial DNA and miRNA of Irritable Bowel Syndrome | NULL | UNKNOWN | Chinese PLA General Hospital | Irritable Bowel Syndrome|Digestive System Disease… | None | Details |
| NCT00511329 | Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease | PHASE2|PHASE3 | TERMINATED | Nationwide Children's Hospital | Arthritis, Juvenile Rheumatoid|Crohn Disease | DRUG: somatropin [rDNA origin] for injection | Details |
| ISRCTN30255103 | Colorectal cancer screening by quantitative analysis of DNA isolated from exfoliated cells sampled from the surface of human rectal mucosa: A pilot study | NULL | Not Recruiting | Colonix Medical Ltd (UK) | Colorectal cancer; inflammatory bowel disease Can… | This study was conducted with two distinct groups… | Details |
| Disease ID | Disease Name | Definition | Category | Related Drugs | Mechanism | |
|---|---|---|---|---|---|---|
| No data available | ||||||
| Strategy ID | Therapeutic Strategy | Synonyms | Related Drugs | Mechanism | |
|---|---|---|---|---|---|
| S08 | Strengthening barrier function | Modulation of barrier function | phosphatidylcholine (lecithin); imiquimod; mongersen | Escherichia coli Nissle (EcN) is a nonpathogenic Gram-negat… | Details |
Mongersen (GED-0301) for Active Crohn's Disease: Results of a Phase 3 Study
PMID: 31850931
Year: 2020
Relationship Type:
Treatment
Score: 8.5
INTRODUCTION: The objective was to assess the efficacy and safety of GED-0301, an antisense oligodeoxynucleotide to Smad7, in active Crohn's disease …
Impact of patient characteristics on the clinical efficacy of mongersen (GED-03…
PMID: 26766141
Year: 2016
Relationship Type:
Treatment
Score: 7.3
BACKGROUND: In a phase 2 study, mongersen, an oral antisense oligonucleotide targeting Smad7, was effective in inducing clinical remission in approxi…
Effects of Mongersen (GED-0301) on Endoscopic and Clinical Outcomes in Patients…
PMID: 28847751
Year: 2018
Relationship Type:
Mechanism
Score: 6.3
Infectious bursal disease (IBD) is an economically important disease of young chickens caused by an Avibirnavirus, the infectious bursal disease vir…