- Raw materials
- Lipid-lowering agents
- Omega-3-carboxylic acids
Omega-3-carboxylic acids API Manufacturers & Suppliers
0 verified results
Get full market intelligence report
All Omega-3-carboxylic acids data. Full access. Full negotiation power
€399,-
Commercial-scale Suppliers
No suppliers found
Sorry, there are currently no suppliers listed for this ingredient. Hopefully we can help you with other ingredients.
Notify me!
Want to be the first to find out when a supplier for Omega-3-carboxylic acids is listed?
Join our notification list by following this page.
Join our notification list by following this page.
List your company
Are you a supplier of Omega-3-carboxylic acids or other APIs and are you looking to list your company on Pharmaoffer?
Click the button below to find out more
Click the button below to find out more
Find CDMO
Looking for a CDMO/CMO that can help you with your pharmaceutical needs?
Click the button below to switch over to the contract services area of Pharmaoffer.
Click the button below to switch over to the contract services area of Pharmaoffer.
When insight is your advantage
Full data, full access, full negotiation power
Total market transparency
|
Supplier trade data access
|
Buyer / supplier flow comparison
Trusted by 30,000+ registered pharma professionals:
Reach multinationals, SMEs, compounding pharmacies & more!
Omega-3-carboxylic acids | GMP-certified suppliers
A medication that supports triglyceride reduction in adults with severe hypertriglyceridemia as an adjunct to diet, addressing lipid abnormalities linked to metabolic disorders.
Therapeutic categories
Fatty Acids, Omega-3
Generic name
Omega-3-carboxylic acids
Molecule type
small molecule
DrugBank ID
DB09568
Approval status
Approved drug, Investigational drug
Primary indications
- OM3-CA is indicated as an adjunct to diet to reduce triglycerides levels in adults patients with severe hypertriglyceridemia (>500 mg/dL)
- The patients involved in this treatment should be laced with an appropriate lipid-lowering diet
- Hypertriglyceridemia is defined as an elevated plasma triglyceride concentration
Product Snapshot
- Omega-3-carboxylic acids are formulated as oral gelatin-coated capsules
- The primary therapeutic use is as an adjunct to diet for reducing triglyceride levels in adult patients with severe hypertriglyceridemia
- The product is approved in the US market with both approved and investigational status
Clinical Overview
Omega-3 carboxylic acids (OM3-CA) are a formulation of omega-3 polyunsaturated free fatty acids primarily consisting of eicosapentaenoic acid (EPA) at approximately 55% and docosahexaenoic acid (DHA) at around 20%. This composition also includes docosapentaenoic acid and minor quantities of excipients such as alpha-tocopherol, gelatin, glycerol, sorbitol, and purified water. Unlike ethyl ester forms of omega-3 fatty acids, OM3-CA is provided as free fatty acids, which contributes to enhanced bioavailability.
OM3-CA is indicated as an adjunct to diet for the treatment of severe hypertriglyceridemia, defined as fasting plasma triglyceride levels exceeding 500 mg/dL, in adult patients. This condition often coexists with metabolic disorders including obesity, type 2 diabetes, metabolic syndrome, and lifestyle factors such as poor diet and alcohol consumption. Treatment with OM3-CA should be combined with an appropriate lipid-lowering diet.
Pharmacodynamically, OM3-CA demonstrates significant triglyceride-lowering effects, with reductions observable as early as 14 days after initiation. Dose-dependent triglyceride decreases up to 25% have been reported at a 4 g daily dose. The mechanism of action involves multiple pathways: EPA and DHA serve as poor substrates for hepatic enzymes involved in triglyceride synthesis and inhibit fatty acid esterification. Additionally, OM3-CA enhances triglyceride clearance by inhibiting acyl-CoA:1,2-diacylglycerol acyltransferase, increasing mitochondrial and peroxisomal beta-oxidation, suppressing hepatic lipogenesis, and elevating lipoprotein lipase activity.
OM3-CA was developed by AstraZeneca Pharmaceuticals and received FDA approval in 2014. It is classified among omega-3 fatty acids and is available as an approved treatment for dyslipidemia.
When sourcing OM3-CA API, quality considerations include verification of free fatty acid content, purity profiles of EPA and DHA, and control of potential oxidative degradation. Compliance with pharmacopeial standards and stability under formulation-relevant conditions is critical for consistent clinical efficacy and safety.
OM3-CA is indicated as an adjunct to diet for the treatment of severe hypertriglyceridemia, defined as fasting plasma triglyceride levels exceeding 500 mg/dL, in adult patients. This condition often coexists with metabolic disorders including obesity, type 2 diabetes, metabolic syndrome, and lifestyle factors such as poor diet and alcohol consumption. Treatment with OM3-CA should be combined with an appropriate lipid-lowering diet.
Pharmacodynamically, OM3-CA demonstrates significant triglyceride-lowering effects, with reductions observable as early as 14 days after initiation. Dose-dependent triglyceride decreases up to 25% have been reported at a 4 g daily dose. The mechanism of action involves multiple pathways: EPA and DHA serve as poor substrates for hepatic enzymes involved in triglyceride synthesis and inhibit fatty acid esterification. Additionally, OM3-CA enhances triglyceride clearance by inhibiting acyl-CoA:1,2-diacylglycerol acyltransferase, increasing mitochondrial and peroxisomal beta-oxidation, suppressing hepatic lipogenesis, and elevating lipoprotein lipase activity.
OM3-CA was developed by AstraZeneca Pharmaceuticals and received FDA approval in 2014. It is classified among omega-3 fatty acids and is available as an approved treatment for dyslipidemia.
When sourcing OM3-CA API, quality considerations include verification of free fatty acid content, purity profiles of EPA and DHA, and control of potential oxidative degradation. Compliance with pharmacopeial standards and stability under formulation-relevant conditions is critical for consistent clinical efficacy and safety.
Identification & chemistry
| Generic name | Omega-3-carboxylic acids |
|---|---|
| Molecule type | Small molecule |
| UNII | F85N2YHE4E |
| DrugBank ID | DB09568 |
Pharmacology
| Summary | OM3-CA reduces hepatic triglyceride synthesis primarily through its major components, eicosapentaenoic acid and docosahexaenoic acid, which act as poor substrates for triglyceride-producing enzymes and inhibit fatty acid esterification. It also promotes triglyceride clearance by modulating targets such as diacylglycerol O-acyltransferase 2 and lipoprotein lipase, enhancing beta-oxidation and decreasing lipogenesis. These combined actions result in significant reductions of circulating triglyceride levels in patients with severe hypertriglyceridemia. |
|---|---|
| Mechanism of action | The reduction of the synthesis of triglycerides in the liver may be caused because the main components of OM3-CA, eicosapentaenoic acid, and docosahexaenoic acid, are poor substrates for the enzymes responsible for the synthesis of triglycerides. These two major components inhibit the esterification of other fatty acids. OM3-CA is also thought to enhance the clearance of triglycerides from the circulating very low-density lipoprotein particles by different potential effects such as inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increase in mitochondrial and peroxisomal beta-oxidation in the liver, decrease lipogenesis in the liver and increase lipoprotein lipase activity. |
| Pharmacodynamics | OM3-CA is very effective in reducing triglyceride levels. After 14 days of treatment, it is possible to observe even a 21% reduction. The reduction of the triglycerides could reach even to 25% in cases with the maximal used concentration of 4 g. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Diacylglycerol O-acyltransferase 2 | Humans | antagonist |
| 3-hydroxyacyl-CoA dehydrogenase type-2 | Humans | potentiator |
| Enoyl-CoA hydratase, mitochondrial | Humans | potentiator |
ADME / PK
| Absorption | When compared to omega-3 -acid ethyl esters, OM3-CA present a 4-fold higher bioavailability. OM3-CA is absorbed directly in the small intestine and the maximal plasma concentration is reached between 4.5-5 hours after initial administration. The absorbed dosage is transferred to the general circulation via the lymphatic system and distributed within tissues throughout the body. The absorption speed and extent is highly promoted by the bile. In preclinical studies performed in dogs, the Cmax, tmax and AUC were reported to be 15.1 mcg/ml, 24 hours and 1210.3 mcg.h/ml, respectively. |
|---|---|
| Half-life | The half-life of OM3-CA depends on the type of component in which for eicosapentaenoic acid it is estimated to be of approximately 4.7-10.8 hours while for docosahexaenoic acid is reported to be of about 7 hours. The half-life of baseline-adjusted at steady-state is of 36 and 46 hours respectively for eicosapentaenoic acid and docosahexaenoic acid. |
| Protein binding | Once OM3-CA is absorbed, it is rapidly incorporated in phospholipids, triglycerides, and cholesteryl esters with only about 1% of the administered dose found as free-unesterified fatty acid. The majority of the eicosapentaenoic acid is bound to plasma proteins and it can represent even 98.5% of the administered dose. |
| Metabolism | OM3-CA is metabolized in the liver following the normal fatty acid oxidation. Once absorbed, they are incorporated into triglycerides, cholesterol esters and phospholipids in tissues. The metabolism is marked by beta-oxidation followed by tricarboxylic acid cycle. It is reported that OM3-CA is an inhibitor of several enzymes such as CYP2C9, CYP2C19 and to a lesser extent to CYP1A2, CYP2E1, CYP3A4. It is thought that the metabolism of OM3-CA is mainly done by CYP3A and CYP4F3B. |
| Route of elimination | OM3-CA does not go under renal excretion. After the metabolism, all the dose is excreted as CO2 and water in the form of expelled air and the rest is excreted in feces. |
| Volume of distribution | This pharmacokinetic property is not available. |
| Clearance | The registered clearance rate at steady-state is of 548 ml/h for eicosapentaenoic acid and 518 ml/h for docohexaenoic acid. |
Formulation & handling
- Omega-3-carboxylic acids are formulated primarily for oral administration in capsule form, including gelatin-coated capsules.
- As a small molecule liquid API, lipid solubility and capsule integrity should be considered in formulation development.
- Absorption of EPA is enhanced with high-fat meals, but dosing can be with or without food without affecting overall stability.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is marketed primarily in the United States, where initial patents expired in 2016, leading to established generic competition; however, additional patents expiring in 2025 may extend market exclusivity for certain formulations or uses. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Omega-3-carboxylic acids is characterized by a limited number of originator companies primarily active in the US market, with branded products such as Epanova. Patents protecting these products extend into 2025, indicating that generic competition is either emerging or expected shortly post-expiry. Global presence outside the US appears limited based on available data. |
|---|
Safety
| Toxicity | Preclinical studies with OM3-CA have shown an absence of a potential carcinogenic effect in males but it is reported to increase the incidence of benign ovarian sex cord-stromal tumors. OM3-CA is not mutagenic, clastogenic and it did not have any effect on fertility. |
|---|
High Level Warnings:
- OM3-CA demonstrated no mutagenic or clastogenic effects in preclinical assays
- Carcinogenicity studies revealed an increased incidence of benign ovarian sex cord-stromal tumors in females, with no carcinogenic potential observed in males
- No adverse impact on fertility was detected in toxicological evaluations
Omega-3-carboxylic acids is a type of Lipid-lowering agents
Lipid-lowering agents are a category of pharmaceutical active ingredients (APIs) that are widely used in the treatment of hyperlipidemia, a condition characterized by elevated levels of lipids (such as cholesterol and triglycerides) in the blood. These agents play a crucial role in managing lipid abnormalities and reducing the risk of cardiovascular diseases.
One of the most commonly prescribed lipid-lowering agents is statins. Statins work by inhibiting an enzyme called HMG-CoA reductase, which is responsible for the production of cholesterol in the liver. By blocking this enzyme, statins effectively lower cholesterol levels in the bloodstream.
Another class of lipid-lowering agents is fibric acid derivatives, which primarily target triglyceride levels. These agents activate a nuclear receptor known as PPAR-alpha, which regulates lipid metabolism. By activating PPAR-alpha, fibric acid derivatives enhance the breakdown of triglycerides and increase the elimination of fatty acids from the bloodstream.
Additionally, bile acid sequestrants are often used as lipid-lowering agents. These agents bind to bile acids in the intestine, preventing their reabsorption. As a result, the liver utilizes more cholesterol to produce new bile acids, leading to a decrease in circulating cholesterol levels.
Lipid-lowering agents are available in various formulations, including tablets, capsules, and suspensions, allowing for convenient administration. They are usually prescribed alongside lifestyle modifications, such as dietary changes and regular exercise, to optimize the management of hyperlipidemia.
It is important to note that the use of lipid-lowering agents should be under the supervision of a healthcare professional, as they may have potential side effects and interactions with other medications. Proper monitoring of lipid levels and regular follow-up visits are essential for ensuring the effectiveness and safety of these pharmaceutical agents.
