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Deoxycholic acid | CAS No: 83-44-3 | GMP-certified suppliers
A medication that reduces moderate to severe submental fat in adults to improve facial contour by targeting localized adipose tissue.
Therapeutic categories
Primary indications
- For improvement in appearance of moderate to severe fullness associated with submental fat in adults
Product Snapshot
- Deoxycholic acid is available primarily as an injectable solution for subcutaneous administration and in oral tablet forms with delayed release and coating
- It is indicated for the reduction of adipose tissue associated with moderate to severe submental fullness
- The compound is approved for use in the US and Canadian markets
Clinical Overview
Clinically, deoxycholic acid is approved for the reduction of moderate to severe submental fat in adults, primarily to improve the aesthetic appearance of facial fullness or convexity. This indication was authorized by the U.S. Food and Drug Administration in April 2015. In this context, it is marketed under the brand name Kybella (Kythera Biopharma) and represents the first pharmacological option for submental fat reduction, offering an alternative to more invasive surgical procedures.
Mechanistically, deoxycholic acid acts by directly disrupting the lipid bilayer of adipocyte membranes, initiating adipocyte lysis. This cytolytic process triggers an inflammatory response that facilitates the clearance of the resulting cellular debris by macrophages. The compound’s activity is markedly limited to protein-poor subcutaneous fat due to inactivation by albumin and tissue-associated proteins. Consequently, protein-rich tissues such as muscle and skin remain largely unaffected, underscoring a degree of tissue specificity and contributing to its safety profile.
Pharmacokinetic parameters related to absorption, distribution, metabolism, and excretion (ADME) are not extensively characterized in the subcutaneous administration context. The localized injection results in minimal systemic exposure, with deoxycholic acid primarily acting at the injection site.
Safety considerations include potential injection-related adverse effects such as localized swelling, pain, erythema, and numbness. Patient selection and injection technique are critical to minimize complications and ensure appropriate tissue targeting.
For API procurement, purity and consistency are paramount given the compound’s cytolytic activity and localized administration. Sourcing from manufacturers with compliance to Good Manufacturing Practices (GMP) and relevant pharmacopoeial standards supports quality assurance and regulatory compliance for pharmaceutical formulation development.
Identification & chemistry
| Generic name | Deoxycholic acid |
|---|---|
| Molecule type | Small molecule |
| CAS | 83-44-3 |
| UNII | 005990WHZZ |
| DrugBank ID | DB03619 |
Pharmacology
| Summary | Deoxycholic acid is a synthetic bile acid that induces adipocytolysis by disrupting adipose cell membranes, leading to localized fat cell breakdown and subsequent clearance via macrophage-mediated inflammation. Its pharmacodynamic activity is primarily confined to protein-poor subcutaneous fat due to inactivation by albumin and tissue proteins, sparing surrounding muscle and skin tissues. The compound interacts with multiple targets including bile acid receptors and enzymes involved in lipid metabolism, facilitating its effect on submental fat reduction. |
|---|---|
| Mechanism of action | As a bile acid, deoxycholic acid emulsifies fat in the gut. Synthetically derived deoxycholic acid, when injected, stimulates a targeted breakdown of adipose cells by disrupting the cell membrane and causing adipocytolysis. This results in an inflammatory reaction and clearing of the adipose tissue remnants by macrophages. Deoxycholic acid's actions are reduced by albumin and tissue-associated proteins, therefore its effect is limited to protein-poor subcutaneous fat tissue. Protein-rich tissues like muscle and skin are unaffected by deoxycholic acid, contributing to its safety profile. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Steroid Delta-isomerase | Pseudomonas putida | |
| PpcA | Geobacter sulfurreducens | |
| Elongation factor Tu GTP-binding domain-containing protein 1 | Humans |
ADME / PK
| Absorption | Deoxycholic acid is rapidly absorbed after subcutaneous administration. After maximum recommended single treatment dose, 100mg, the post-treatment plasma levels returned to endogenous levels within 24 hours. With the proposed treatment guideline, no accumulation is expected. |
|---|---|
| Protein binding | 98% |
| Metabolism | Deoxycholic acid is not metabolized to any significant extent under normal conditions. |
| Route of elimination | The exogenous deoxycholic acid joins the endogenous bile acid pool in the enterohepatic circulation and is excreted unchanged in feces along with endogenous deoxycholic acid. |
Formulation & handling
- Deoxycholic acid is available in both oral solid dosage forms (tablets) and injectable solutions for parenteral or subcutaneous administration.
- As a small molecule with low water solubility and moderate lipophilicity (LogP 3.79), formulation strategies should address its limited aqueous solubility.
- Storage and handling should consider its sensitivity to moisture and light to maintain stability in both solid and solution forms.
Regulatory status
| Lifecycle | The API is currently protected by several patents in the United States with expiration dates ranging from 2025 to 2028, and it is marketed in both the US and Canada. As patent expiry approaches, generic competition is expected to increase, impacting market exclusivity and product lifecycle. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for deoxycholic acid includes multiple originator companies with branded products primarily marketed in the US and Canada, such as Belkyra and Kybella. The presence of several active US patents with expiration dates ranging from 2025 to early 2028 indicates that generic competition is likely forthcoming but not yet fully established. This suggests a transitioning market where branded supply dominates, with increasing opportunities for generic sourcing as patents expire. |
|---|
Deoxycholic Acid is a type of Slimming products
Slimming products are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that are specifically formulated to aid in weight loss and promote a healthy body mass index (BMI). These products are designed to target various aspects of weight management, including appetite control, metabolism enhancement, and fat burning.
One common type of slimming API is thermogenic agents. These substances work by increasing the body's core temperature, which stimulates the metabolism and promotes the burning of calories and fat. Popular thermogenic agents include caffeine, green tea extract, and capsaicin.
Another group of slimming APIs are appetite suppressants. These compounds work by reducing hunger pangs and cravings, helping individuals to consume fewer calories. Common appetite suppressants used in slimming products include glucomannan, a dietary fiber that expands in the stomach, and 5-HTP, a precursor to serotonin, a neurotransmitter that regulates appetite.
Additionally, lipase inhibitors are often included in slimming APIs. These substances inhibit the enzyme lipase, which is responsible for breaking down dietary fat. By blocking the action of lipase, these APIs prevent the absorption of dietary fat and reduce calorie intake.
Slimming products often combine multiple APIs to create synergistic effects and enhance weight loss results. It's important to note that slimming products should be used in conjunction with a balanced diet and regular exercise for optimal results. Prior to using any slimming APIs, it is recommended to consult with a healthcare professional to ensure their safe and effective use.
Deoxycholic Acid (Slimming products), classified under Others
The others category refers to pharmaceutical APIs that do not fall under specific classifications such as antibiotics, antivirals, analgesics, or cardiovascular drugs. These APIs are diverse in nature and serve various therapeutic purposes, making them a crucial component of pharmaceutical formulations.
Pharmaceutical companies develop APIs in the others category to address specific medical conditions or target novel biological pathways. This category includes APIs used in oncology, neurology, immunology, and other specialized areas of medicine. The APIs in this category are often designed to interact with specific molecular targets or receptors, providing targeted therapeutic effects.
The development of APIs in the others category requires extensive research and testing to ensure their efficacy, safety, and compliance with regulatory standards. Pharmaceutical manufacturers employ advanced techniques such as chemical synthesis, biotechnology, and genetic engineering to produce these APIs.
Due to the broad range of applications and therapeutic uses, APIs in the others category contribute significantly to the advancement of medical treatments. Pharmaceutical companies constantly strive to innovate and discover new APIs within this category to address unmet medical needs and improve patient outcomes.
In conclusion, the others category of pharmaceutical APIs encompasses a diverse range of active ingredients used in drug formulation. These APIs play a crucial role in developing innovative therapies across various therapeutic areas, contributing to advancements in healthcare and patient well-being.
Deoxycholic Acid API manufacturers & distributors
Compare qualified Deoxycholic Acid API suppliers worldwide. We currently have 5 companies offering Deoxycholic Acid API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| Curia | Producer | United States | Spain | CoA, GMP, MSDS, USDMF | 106 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Guangzhou Green Cross Pha... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS | 15 products |
| ICE Pharma | Producer | Italy | Italy | BSE/TSE, CEP, CoA, FDA, GMP, MSDS | 18 products |
| Prodotti Chimici e Alimen... | Producer | Italy | Italy | CEP, CoA, FDA, GMP | 4 products |
When sending a request, specify which Deoxycholic 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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