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[{"orgOrder":0,"company":"Galectin Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Galectin Therapeutics Submits Seamless Adaptively-Designed Phase 2b\/3 NASH-RX Protocol in NASH Cirrhosis","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"GEORGIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Galectin Therapeutics"},{"orgOrder":0,"company":"Galectin Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Galectin Therapeutics Announces Commencement of Patient Enrollment of the Adaptively-Designed Phase 2b\/3 Trial of Belapectin","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"GEORGIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Galectin Therapeutics"},{"orgOrder":0,"company":"Galectin Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Galectin Therapeutics to Present at 4th Global NASH Congress","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"GEORGIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Galectin Therapeutics"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Calliditas Receives FDA Fast Track Designation for Setanaxib in PBC","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Calliditas Therapeutics AB"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"US FDA Grants Fast Track Status to Calliditas\u2019 Setanaxib for PBC","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Calliditas Therapeutics AB"},{"orgOrder":0,"company":"Galectin Therapeutics","sponsor":"Richard E. Uihlein","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Galectin Therapeutics Announces $20 Million Convertible Debt Financing from Its Chairman, Richard E. Uihlein","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"GEORGIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Galectin Therapeutics"},{"orgOrder":0,"company":"Galectin Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Galectin Pharmaceuticals to Present Six Scientific Abstracts at The Liver Meeting\u2122 2021, Hosted by the AASLD","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"GEORGIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Galectin Therapeutics"},{"orgOrder":0,"company":"Zydus Lifesciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zydus Announces EPICS-IIITM Phase 2(b)\/3 Adaptive Pivotal Clinical Trial of Saroglitazar Mg in PBC","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Zydus Lifesciences"},{"orgOrder":0,"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Patient Randomized in Pivotal TRANSFORM Study with Setanaxib","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Calliditas Therapeutics AB"},{"orgOrder":0,"company":"Galectin Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Galectin Therapeutics Reports the Positive Outcome of the First Data and Safety Monitoring Board for NAVIGATE, its Seamless, Adaptive Phase 2b\/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"GEORGIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Galectin Therapeutics"},{"orgOrder":0,"company":"Galectin Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Galectin Therapeutics to Present in Upcoming Conferences","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"GEORGIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Galectin Therapeutics"},{"orgOrder":0,"company":"Galectin Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Galectin Therapeutics to Share Five Scientific Presentations at The Liver Meeting\u2122 2022, Hosted by the AASLD","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"GEORGIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Galectin Therapeutics"},{"orgOrder":0,"company":"Galectin Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Galectin Therapeutics Announces the End of Enrollment of NAVIGATE, its Seamless, Adaptive Phase 2b\/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"GEORGIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Galectin Therapeutics"}]
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GR-MD-02 (Belapectin) is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Belapectin binds to galectin-3 and disrupts its major role in diseases that involve scarring of organs, including fibrotic disorders.
Lead Product(s):
Belapectin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GR-MD-02
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableJanuary 05, 2023
Details:
GR-MD-02 (belapectin) is complex carbohydrate drug that targets galectin-3, a critical protein in pathogenesis of NASH and fibrosis also it binds to galectin-3 and disrupts its function.
Lead Product(s):
Belapectin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GR-MD-02
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableNovember 01, 2022
Details:
Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Belapectin binds to galectin-3 and disrupts its function.
Lead Product(s):
Belapectin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GR-MD-02
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableOctober 14, 2022
Details:
Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis.
Lead Product(s):
Belapectin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GR-MD-02
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableApril 14, 2022
Details:
The TRANSFORM Phase 2b/3 trial for GKT831 (setanaxib), a NOX1 and NOX4 inhibitor, will investigate the effect of setanaxib versus placebo on alkaline phosphatase reduction in patients with PBC also has shown evidence of anti-fibrotic activity in a Phase II clinical trial.
Lead Product(s):
Setanaxib
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GKT831
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableFebruary 15, 2022
Details:
Company announced that it has received permission from the USFDA to initiate the Phase 2(b)/3 clinical trial to evaluate efficacy and safety of Lipaglyn (Saroglitazar Magnesium) in subjects with PBC.
Lead Product(s):
Saroglitazar magnesium
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Lipaglyn
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableDecember 10, 2021
Details:
Galectin-3, a glycan binding protein, plays a central role to foster liver inflammation and fibrosis in NASH cirrhosis. Belapectin is a galectin-3 inhibitor in development for NASH cirrhosis.
Lead Product(s):
Belapectin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GR-MD-02
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableNovember 05, 2021
Details:
The financing will support the progress of belapectin in NAVIGATE trial for patients with NASH cirrhosis and exploring in combination for the treatment of metastatic melanoma.
Lead Product(s):
Belapectin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GR-MD-02
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator:
Richard E. Uihlein
Deal Size: UndisclosedUpfront Cash: Undisclosed
Deal Type: FinancingSeptember 21, 2021
Details:
Following positive results from a Phase 1 study conducted in 2020 which evaluated higher doses of setanaxib in healthy volunteers, Calliditas is planning to initiate a pivotal Phase 2/3 study in PBC.
Lead Product(s):
Setanaxib
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GKT137831
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableAugust 09, 2021
Details:
In a Phase 2 clinical trial, setanaxib demonstrated evidence of anti-fibrotic activity as measured by Fibroscan, combined with a favorable tolerability profile, as well as a statistically significant impact on fatigue.
Lead Product(s):
Setanaxib
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GKT831
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableAugust 09, 2021
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