GB0139 ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
85Idiopathic interstitial pneumonia3

85. Idiopathic interstitial pneumonia


Clinical trials : 598 Drugs : 435 - (DrugBank : 116) / Drug target genes : 100 - Drug target pathways : 210
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PhaseCountries
1EUCTR2018-002664-73-IE
(EUCTR)
25/05/202020/12/2018Clinical study of the inhaled research drug GB0139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks.GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of GB0139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks Patients with idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: GB0139 (previously known as TD139)
Product Code: GB0139 (previously known as TD139)
INN or Proposed INN: GB0139 (previously known as TD139)
Other descriptive name: DEX284
Galecto Biotech ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2Germany;Georgia;Australia;Poland;Belgium;Canada;France;Italy;United Kingdom;Russian Federation;Israel;Ireland;Ukraine;Spain;United States
2EUCTR2018-002664-73-PL
(EUCTR)
09/07/201914/03/2019Clinical study of the inhaled research drug GB0139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks.GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of GB0139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks patients with idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: GB0139 (previously known as TD139)
Product Code: GB0139 (previously known as TD139)
INN or Proposed INN: GB0139 (previously known as TD139)
Other descriptive name: DEX284
Galecto Biotech ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
141Phase 2United States;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Poland;Belgium;Australia;Georgia;Germany
3NCT03832946
(ClinicalTrials.gov)
February 19, 20194/2/2019A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)GALACTIC-1 -A Randomized, Double-blind, Multicentre, Parallel, Placebo-controlled Phase 2b Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Investigating the Efficacy and Safety of GB0139, an Inhaled Galectin-3 Inhibitor Administered Via a Dry Powder Inhaler Over 52 WeeksIdiopathic Pulmonary Fibrosis (IPF)Drug: GB0139;Drug: PlaceboGalecto Biotech ABSyneos Health;bioRASI, LLCRecruiting40 YearsN/AAll500Phase 2United States;Australia;Belgium;Canada;France;Georgia;Germany;Ireland;Israel;Italy;Poland;Spain;Ukraine;United Kingdom