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Details:
Ocaliva (obeticholic acid) is a farnesoid X receptor (FXR) agonist, which is being evaluated for the treatment of individuals with primary biliary cholangitis.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 29, 2024
Details:
Through the acquisition, Alfasigma adds Ocaliva (obeticholic acid), a farnesoid X receptor agonist approved in the United States for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alfasigma
Deal Size: $794.0 million Upfront Cash: $794.0 million
Deal Type: Acquisition November 08, 2023
Details:
Through the acquisition, Alfasigma adds Ocaliva (obeticholic acid), a farnesoid X receptor agonist approved in the United States for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA.
Lead Product(s): Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alfasigma
Deal Size: $794.0 million Upfront Cash: $794.0 million
Deal Type: Acquisition September 26, 2023
Details:
Ocaliva (obeticholic acid) is a FXR agonist, activating enterocytes and hepatocytes FXRs, thereby reducing toxic levels of bile acids and promoting insulin sensitivity. This results in low risk of lipid deposition into hepatocytes, reducing progression of NASH.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2023
Details:
Ocaliva (obeticholic acid) is a FXR agonist, activating enterocytes and hepatocytes FXRs, thereby reducing toxic levels of bile acids and promoting insulin sensitivity. This results in low risk of lipid deposition into hepatocytes, reducing progression of NASH.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2023
Details:
USFDA has granted orphan drug designation for the combination of ocaliva (obeticholic acid), a farnesoid X receptor agonist and bezafibrate, a PPAR agonist, for the treatment of individuals with primary biliary cholangitis.
Lead Product(s): Obeticholic Acid,Bezafibrate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2023
Details:
Ocaliva (obeticholic acid) is a FXR agonist, activating enterocytes and hepatocytes FXRs, thereby reducing toxic levels of bile acids and promoting insulin sensitivity. This results in low risk of lipid deposition into hepatocytes, reducing progression of NASH.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 10, 2023
Details:
Ocaliva (obeticholic acid) is a FXR agonist, activating enterocytes and hepatocytes FXRs, thereby reducing toxic levels of bile acids and promoting insulin sensitivity. This results in low risk of lipid deposition into hepatocytes, reducing progression of NASH.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2023
Details:
Ocaliva (Obeticholic acid) is a FXR agonist, activating enterocytes and hepatocytes FXRs, thereby reducing toxic levels of bile acids and promoting insulin sensitivity. This results in low risk of lipid deposition into hepatocytes, reducing progression of NASH.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2023
Details:
A pre-specified interim analysis was conducted in 931 subjects who had a liver biopsy at Month 18 to assess the effect of Obeticholic Acid (Ocaliva) on liver histology as compared to baseline biopsies.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 23, 2022