Mongersen Sodium

Summary

Mongersen Sodium (CHEMBL3707383) is a phase-3 clinical-stage oligonucleotide; indicated across 2 conditions including crohn disease and ulcerative colitis.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Oligonucleotide
• Indications: 2 conditions
• Clinical trials: 7

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3707383
Name	Mongersen Sodium
Type	Oligonucleotide
Max phase	3

Also known as: GED-0301, GED-0301 SODIUM, Mongersen sodium, MONGERSEN SODIUM

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

2 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
Crohn disease	3	MONDO:0005011	EFO:0000384
ulcerative colitis	2	MONDO:0005101	EFO:0000729

Clinical trials

Total trials: 7.

Phase distribution

Phase	Trials
PHASE3	3
PHASE2	2
PHASE1	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT02596893	PHASE3	TERMINATED	Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn’s Disease
NCT02641392	PHASE3	TERMINATED	A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn’s Disease
NCT02974322	PHASE3	WITHDRAWN	A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn’s Disease
NCT02601300	PHASE2	COMPLETED	An Efficacy and Safety Study of Mongersen (GED-0301) in Subjects With Active Ulcerative Colitis
NCT02685683	PHASE2	TERMINATED	Pharmacodynamic and Clinical Outcome Study of Mongersen in Patients With Crohn’s Disease
NCT02367183	PHASE1	COMPLETED	A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn’s Disease
NCT02957474	PHASE1	COMPLETED	A Study to Evaluate the Effect of Food, Formulation Strength, and a Proton Pump Inhibitor on GED 0301 Pharmacokinetics in Healthy Adult Subjects

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).