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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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