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US Approved Rx

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Primary Target

Bile acid receptor FXR

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Highest Phase

Approved

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Approval Year

2015

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2016

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Condition

Bile acid synthesis disorders

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Peroxisomal disorders

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Primary biliary cholangitis

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Treatment Modality

Primary

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Originator

Strecker, A.|Hammarsten, O.|Mylius, F.|Wieland, H.

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GlaxoSmithKline

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Chemical

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CAS

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CHEBI

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EPA CompTox

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EVMPD

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FDA UNII

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ATC Level 1

ALIMENTARY TRACT AND METABOLISM

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ATC Level 2

BILE AND LIVER THERAPY

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ATC Level 3

BILE THERAPY

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ATC Level 4

Bile acid preparations

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Substance Form

Principal Form

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Salts, Hydrates, Esters, etc.

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OBETICHOLIC ACID

0462Z4S4OZ

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Status:

US Approved Rx (2016)

First approved in 2016

Class (Stereo):

CHEMICAL (ABSOLUTE)

Targets:

Bile acid receptor FXR

Conditions:

Primary biliary cholangitis

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 n...

umerous 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.

CHOLIC ACID

G1JO7801AE

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Status:

US Approved Rx (2015)

First approved in 2015

Class (Stereo):

CHEMICAL (ABSOLUTE)

Targets:

Bile acid receptor FXR

Conditions:

Bile acid synthesis disorders

Peroxisomal disorders

Cholic acid is a primary bile acid synthesized from cholesterol in the liver. Endogenous bile acids including cholic acid enhance bile flow and provide the physiologic feedback inhibition of bile acid synthesis. The mechanism of action of cholic acid...

has not been fully established; however, it is known that cholic acid and its conjugates are endogenous ligands of the nuclear receptor, farnesoid X receptor (FXR). FXR regulates enzymes and transporters that are involved in bile acid synthesis and in the enterohepatic circulation to maintain bile acid homeostasis under normal physiologic conditions. U.S. Food and Drug Administration approved Cholbam (cholic acid) capsules, the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders).

SODIUM CHOLATE

NU3Y4CCH8Z

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Status:

US Approved Rx (2015)

First approved in 2015

Class (Stereo):

CHEMICAL (ABSOLUTE)

Targets:

Bile acid receptor FXR

Conditions:

Bile acid synthesis disorders

Peroxisomal disorders

Cholic acid is a primary bile acid synthesized from cholesterol in the liver. Endogenous bile acids including cholic acid enhance bile flow and provide the physiologic feedback inhibition of bile acid synthesis. The mechanism of action of cholic acid...

has not been fully established; however, it is known that cholic acid and its conjugates are endogenous ligands of the nuclear receptor, farnesoid X receptor (FXR). FXR regulates enzymes and transporters that are involved in bile acid synthesis and in the enterohepatic circulation to maintain bile acid homeostasis under normal physiologic conditions. U.S. Food and Drug Administration approved Cholbam (cholic acid) capsules, the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders).

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