Drug Insights

Exploring Cholic Acid's Revolutionary R&D Successes and its Mechanism of Action on Drug Target

26 September 2023
4 min read

Cholic Acid's R&D Progress

Cholic Acid is a small molecule drug that targets the FXR receptor. It has been approved for use in the treatment of nervous system diseases, congenital disorders, digestive system disorders, endocrinology and metabolic disease, and urogenital diseases. The drug is primarily indicated for the treatment of disorders related to bile acid and cholesterol metabolism, such as bile acid synthesis defect, liver diseases, peroxisomal disorders, steatorrhea, zellweger syndrome and etc.

Cholic Acid was developed by Cell Therapy Ltd., an originator organization in the pharmaceutical industry. It has received approval for use in multiple countries, with its first approval granted in the European Union in September 2013. Which suggests that it has undergone rigorous testing and evaluation to demonstrate its safety and efficacy. The drug has also obtained orphan drug status, indicating its potential to treat rare diseases or conditions.

As a small molecule drug, Cholic Acid is designed to interact with the FXR receptor, which plays a crucial role in regulating bile acid synthesis and cholesterol metabolism. By targeting this receptor, the drug aims to restore normal bile acid levels and improve the associated metabolic processes.

The approval of Cholic Acid in multiple countries and its orphan drug status highlight its potential as a treatment option for various disorders related to bile acid and cholesterol metabolism. 

Overall, Cholic Acid represents a significant advancement in the field of biomedicine, particularly in the treatment of disorders affecting the nervous system, congenital conditions, digestive system disorders, endocrinology and metabolic diseases, and urogenital diseases. Its approval and orphan drug status further emphasize its potential to address unmet medical needs in these therapeutic areas.

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Mechanism of Action for Cholic Acid: FXR agonists

FXR agonists are a type of medication that activate the farnesoid X receptor (FXR) in the body. The FXR is a nuclear receptor that plays a crucial role in regulating various metabolic processes, particularly those related to bile acid synthesis, glucose metabolism, and lipid homeostasis.

From a biomedical perspective, FXR agonists are of interest in the field of biomedicine because they have the potential to treat various diseases and conditions. By activating the FXR, these agonists can help reduce liver fat, inflammation and fibrosis, thereby improving liver health.

Furthermore, FXR agonists have also been investigated for their potential therapeutic effects in other metabolic disorders such as type 2 diabetes and dyslipidemia. By targeting the FXR pathway, these drugs can modulate glucose and lipid metabolism, leading to improved glycemic control and lipid profiles.

Drug Target R&D Trends for Cholic Acid

According to Patsnap Synapse, as of 7 Sep 2023, there are a total of 59 FXR drugs worldwide, from 69 organizations, covering 63 indications, and conducting 444 clinical trials.

The analysis of the current competitive landscape of target FXR reveals that multiple companies are actively involved in the development of drugs targeting this specific target. Intercept Pharmaceuticals, Inc.AbbVie, Inc., and Travere Therapeutics, Inc. are the companies with the highest stage of development, with drugs in the approved phase. The R&D progress of these companies varies, with drugs in different stages of development. Several drugs under the target FXR have been approved for indications related to liver diseases, bile acid synthesis defects, and other related conditions. Small molecule drugs are progressing rapidly, indicating intense competition. China is one of the countries/locations developing fastest under the target FXR, and has shown progress in the development of drugs under this target. Overall, the target FXR presents a competitive landscape with multiple companies and drug types involved in the development of innovative drugs for various indications.

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Conclusion

Overall, FXR agonists are a class of drugs that activate the FXR receptor in the body, and they hold promise for the treatment of various metabolic disorders, particularly those involving liver health and glucose-lipid metabolism.

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