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Bile acid synthesis disorders

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Bile acid receptor FXR

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Approval Year

2015

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Primary

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Originator

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

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BILE THERAPY

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Bile acid preparations

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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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