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Chenodeoxycholic acid | CAS No: 474-25-9 | GMP-certified suppliers
A medication that treats radiolucent cholesterol gallstones in patients with elevated surgical risk by promoting gradual dissolution and improving bile acid balance.
Therapeutic categories
Primary indications
- Chenodiol is indicated for patients with radiolucent stones in well-opacifying gallbladders, in whom selective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease or age
- Chenodiol will not dissolve calcified (radiopaque) or radiolucent bile pigment stones
Product Snapshot
- Chenodeoxycholic acid is formulated as oral capsules and film-coated tablets
- It is primarily used for the dissolution of radiolucent gallstones in patients at increased surgical risk
- The product is approved for use in key regulatory markets including the US and EU
Clinical Overview
Clinically, chenodeoxycholic acid is indicated for the treatment of radiolucent cholesterol gallstones in patients whose gallbladders are well visualized by oral cholecystography, particularly when surgery poses elevated risk due to systemic disease or advanced age. It is important to note that chenodiol is ineffective against calcified (radiopaque) gallstones or those composed predominantly of bile pigments.
The mechanism of action involves suppression of hepatic synthesis of both cholesterol and cholic acid. By partially replacing cholic acid and its metabolite deoxycholic acid within the bile acid pool, chenodeoxycholic acid promotes desaturation of biliary cholesterol, facilitating gradual dissolution of cholesterol gallstones. Additionally, bile acids such as chenodiol may engage the farnesoid X receptor (FXR), a nuclear receptor regulating bile acid synthesis and transport, further influencing hepatic and intestinal cholesterol dynamics.
Pharmacokinetic details emphasize hepatic metabolism, including interactions with cytochrome P-450 enzymes, notably CYP3A4, and inhibition of UGT2B7, which may be relevant in drug-drug interaction assessments. The safety profile necessitates monitoring for hepatotoxicity and gastrointestinal adverse effects during therapy.
Chenodeoxycholic acid is marketed under various brand names and distributed globally for bile acid replacement and litholytic therapy, classified under bile acid preparations and gastrointestinal agents.
From an API sourcing perspective, ensuring high purity and consistent stereochemistry is critical given the compound’s epimeric nature relative to ursodeoxycholic acid. Compliance with pharmacopeial standards and validation of impurity profiles, especially potential epimers or degradation products, is essential for regulatory acceptance and clinical efficacy.
Identification & chemistry
| Generic name | Chenodeoxycholic acid |
|---|---|
| Molecule type | Small molecule |
| CAS | 474-25-9 |
| UNII | 0GEI24LG0J |
| DrugBank ID | DB06777 |
Pharmacology
| Summary | Chenodiol acts by suppressing hepatic synthesis of cholesterol and cholic acid, leading to a remodeled bile acid pool that reduces biliary cholesterol saturation. Its primary targets include bile acid receptors such as FXR and associated nuclear and G-protein coupled receptors, which modulate bile acid synthesis and transport. Therapeutically, Chenodiol facilitates the gradual dissolution of radiolucent cholesterol gallstones by decreasing cholesterol concentration in bile. |
|---|---|
| Mechanism of action | Chenodiol suppresses hepatic synthesis of both cholesterol and cholic acid, gradually replacing the latter and its metabolite, deoxycholic acid in an expanded bile acid pool. These actions contribute to biliary cholesterol desaturation and gradual dissolution of radiolucent cholesterol gallstones in the presence of a gall-bladder visualized by oral cholecystography. Bile acids may also bind the the bile acid receptor (FXR) which regulates the synthesis and transport of bile acids. |
| Pharmacodynamics | It acts by reducing levels of cholesterol in the bile, helping gallstones that are made predominantly of cholesterol to dissolve. Chenodeoxycholic acid is ineffective with stones of a high calcium or bile acid content. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Bile acid receptor | Humans | other |
| Nuclear receptor subfamily 1 group I member 2 | Humans | |
| G-protein coupled bile acid receptor 1 | Humans |
ADME / PK
| Absorption | Chenodiol is well absorbed from the small intestine. |
|---|---|
| Metabolism | Chenodiol is well absorbed from the small intestine and taken up by the liver where it is converted to its taurine and glycine conjugates and secreted in bile. At steady-state, an amount of chenodiol near the daily dose escapes to the colon and is converted by bacterial action to lithocholic acid. About 80% of the lithocholate is excreted in the feces; the remainder is absorbed and converted in the liver to its poorly absorbed sulfolithocholyl conjugates. During chenodiol therapy there is only a minor increase in biliary lithocholate, while fecal bile acids are increased three- to fourfold. |
| Route of elimination | About 80% of its bacterial metabolite lithocholate is excreted in the feces. |
Formulation & handling
- Chenodeoxycholic acid is a small molecule bile acid derivative intended for oral administration in capsule or tablet form.
- Low aqueous solubility necessitates formulation strategies to enhance bioavailability and ensure consistent dosing.
- Stable in solid form with no special handling precautions related to sensitivity to food or moisture reported.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is currently off-patent in both the US and EU, supporting a mature market with established generic competition. Regulatory approvals and product availability reflect ongoing lifecycle management in these regions. |
|---|
| Markets | US, EU |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for chenodeoxycholic acid includes multiple originator companies producing branded products across the US and EU markets. The presence of several branded formulations indicates established global distribution. Patent expirations suggest the availability of generic competition, supporting broader access in these regions. |
|---|
Safety
| Toxicity | Hepatotoxic. |
|---|
- Hepatotoxic potential requires monitoring of liver function during handling and processing
- Avoid inhalation and skin contact to minimize systemic exposure
- Use appropriate engineering controls and personal protective equipment to prevent occupational exposure
Chenodeoxycholic acid is a type of Bile acid preparations
Bile acid preparations are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that are derived from natural bile acids. Bile acids are synthesized in the liver and play a crucial role in the digestion and absorption of dietary fats. These preparations are commonly used in the pharmaceutical industry for various therapeutic purposes.
Bile acid preparations are known for their ability to facilitate the solubilization and absorption of poorly soluble drugs, thereby enhancing their bioavailability. They can be used in the formulation of oral solid dosage forms, such as tablets and capsules, to improve drug dissolution and systemic absorption.
Moreover, bile acid preparations also exhibit therapeutic properties on their own. They are used in the treatment of certain liver disorders, such as cholestasis, where the flow of bile from the liver is impaired. These preparations help restore bile flow and promote the excretion of bile acids, aiding in the management of liver conditions.
In addition, bile acid preparations have shown potential in the treatment of metabolic disorders, including dyslipidemia and obesity. By modulating lipid metabolism, they can help reduce cholesterol levels and promote weight loss.
Overall, bile acid preparations are versatile pharmaceutical APIs that offer multiple benefits, including enhanced drug solubility, improved bioavailability, and therapeutic effects on liver and metabolic disorders. Their use in the pharmaceutical industry continues to expand, offering new opportunities for drug development and patient care.
Chenodeoxycholic acid (Bile acid preparations), classified under Gastrointestinal Agents
Gastrointestinal Agents belong to the pharmaceutical API category that focuses on treating disorders and ailments related to the digestive system. These agents play a crucial role in addressing various gastrointestinal conditions, such as acid reflux, ulcers, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD).
One of the key types of gastrointestinal agents is proton pump inhibitors (PPIs), which work by reducing the production of stomach acid. PPIs help in treating conditions like gastroesophageal reflux disease (GERD) and peptic ulcers. Another essential class of agents is antacids, which neutralize excessive stomach acid, providing relief from heartburn and indigestion.
Gastrointestinal agents also include antispasmodics that alleviate abdominal cramps and spasms associated with conditions like IBS. These drugs work by relaxing the smooth muscles of the digestive tract. Additionally, there are drugs categorized as laxatives that aid in relieving constipation by promoting bowel movements.
Moreover, certain gastrointestinal agents act as antiemetics, effectively reducing nausea and vomiting. These drugs are particularly useful for patients undergoing chemotherapy or experiencing motion sickness.
Pharmaceutical companies develop and manufacture a wide range of gastrointestinal agents in various forms, including tablets, capsules, suspensions, and injections. These agents are typically formulated using active pharmaceutical ingredients (APIs) and other excipients to ensure their efficacy and safety.
In conclusion, gastrointestinal agents form a vital category of pharmaceutical APIs, providing relief from digestive disorders and improving overall gastrointestinal health. The availability of diverse agents catering to different conditions ensures that patients can receive targeted treatment for their specific gastrointestinal needs.
Chenodeoxycholic acid API manufacturers & distributors
Compare qualified Chenodeoxycholic acid API suppliers worldwide. We currently have 4 companies offering Chenodeoxycholic acid API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Erregierre | Producer | Italy | Italy | CoA, GMP | 44 products |
| ICE Pharma | Producer | Italy | Italy | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, JDMF, KDMF, MSDS, USDMF, WC | 18 products |
| Metapharmaceutical Indust... | Producer | Spain | Italy | BSE/TSE, CEP, CoA, GDP, GMP, MSDS | 21 products |
| PharmaZell | Producer | Germany | India | BSE/TSE, CoA, FDA, GDP, GMP, MSDS, WHO-GMP | 31 products |
When sending a request, specify which Chenodeoxycholic acid API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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