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Search results for "obeticholic acid" in Related Substance Name (exact match)
Status:
US Approved Rx
(2016)
Source:
NDA207999
(2016)
Source URL:
First approved in 2016
Source:
NDA207999
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Obeticholic acid (also known as INT-747), is a potent, orally bioavailable farnesoid X receptor (FXR) agonist. The key role of the farnesoid X receptor (FXR) as a regulator of bile and cholesterol metabolism in the liver, with preclinical data from numerous studies providing strong rationale for the advancement of FXR agonists as hepatoprotective therapeutics in chronic liver disease. Obeticholic acid is marketed under the trade name Ocaliva. Ocaliva is specifically indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
Status:
Possibly Marketed Outside US
Source:
Octaplasma by Octapharma Pharmazeutika Produktionsges M B H [Canada]
Source URL:
First approved in 2013
Source:
BLA125416
Source URL:
Class:
MIXTURE
Status:
Investigational
Source:
NCT00374855: Phase 2 Interventional Completed Mild Hypertension
(2006)
Source URL:
Class:
PROTEIN
Status:
Investigational
Source:
NCT02598648: Not Applicable Interventional Recruiting Acute Respiratory Distress Syndrome
(2015)
Source URL:
Class:
PROTEIN
Status:
Investigational
Source:
NCT03333824: Phase 1 Interventional Completed Solid Tumours
(2017)
Source URL:
Class:
PROTEIN