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Sulodexide | CAS No: 57821-29-1 | GMP-certified suppliers
A medication that supports management of vascular conditions with elevated thrombotic risk, including peripheral arterial disease, post‑myocardial infarction states, venous disorders, and diabetes‑related complications.
Therapeutic categories
Primary indications
- Sulodexide has been used clinically for the prophylaxis and treatment of vascular diseases with increased risk of thrombosis, including intermittent claudication, peripheral arterial occlusive disease and post-myocardial infarc-tion
- Also investigated in the treatment of diabetic kidney disease and diabetic neuropathy
- New anti-inflammatory properties have also extended its use in venous disease
Product Snapshot
- Sulodexide is supplied as an oral and parenteral glycosaminoglycan preparation in capsule and injectable solution forms
- It is used for vascular conditions associated with thrombotic risk and is also explored for diabetic kidney disease, diabetic neuropathy, and inflammatory venous disorders
- It is approved in several non‑US markets and remains investigational in regions without formal FDA or EMA authorization
Clinical Overview
Pharmacologically, sulodexide exhibits antithrombotic, profibrinolytic, endothelial‑protective, and anti‑inflammatory activities. Compared with unfractionated heparin, its lower molecular weight facilitates systemic absorption and yields a longer half‑life with limited global anticoagulation. It potentiates antithrombin III and heparin cofactor II, enabling inhibition of thrombin and factor Xa. The agent enhances fibrinolysis through tissue plasminogen activator release and reduction of plasminogen activator inhibitor. It also interferes with platelet adhesion and platelet activation induced by cathepsin G and thrombin.
Endothelial‑protective effects are linked to the induction of growth factors involved in vascular integrity. Anti‑inflammatory activity is mediated by modulation of macrophage‑derived mediators, contributing to downstream antiproliferative effects, including regulation of factors such as VEGF and FGF. Intravenous administration has been shown to stimulate release of tissue factor pathway inhibitor, reinforcing its antithrombotic profile. Sulodexide also suppresses leukocyte secretion of matrix metalloproteinases, particularly MMP‑9, in a dose‑dependent manner.
The mechanism of action reflects additive contributions from both glycosaminoglycan fractions: dermatan sulfate catalyzes thrombin inhibition through heparin cofactor II, while fast‑moving heparin enhances antithrombin III activity.
Absorption, distribution, metabolism, and excretion parameters reported in the literature indicate systemic availability following oral and parenteral administration, but detailed quantitative values vary across studies and are formulation‑dependent. Safety considerations include bleeding risk, though the overall anticoagulant effect is generally lower than that of heparin.
Branded formulations exist in several regions, but availability varies globally. For API procurement, suppliers should provide robust characterization data confirming glycosaminoglycan composition, molecular weight distribution, and impurities consistent with pharmacopeial or regulatory expectations.
Identification & chemistry
| Generic name | Sulodexide |
|---|---|
| Molecule type | Biotech |
| CAS | 57821-29-1 |
| UNII | 75HGV0062C |
| DrugBank ID | DB06271 |
Pharmacology
| Summary | Sulodexide exerts antithrombotic activity by enhancing thrombin inhibition through dual catalysis of antithrombin III and heparin cofactor II, reflecting the actions of its heparin‑ and dermatan sulfate–derived components. It additionally influences fibrinolysis, platelet function, endothelial integrity, and inflammatory mediator release, contributing to broader anticoagulant and vascular‑protective pharmacodynamic effects. These actions align with its use in conditions characterized by elevated thrombotic or vascular inflammatory burden. |
|---|---|
| Mechanism of action | Thrombin inhibition produced by sulodexide is due to the additive effect of its components, namely, heparin cofactor II (HCII) catalysis by dermatan sulfate and antithrombin-III catalysis by fast moving heparin (FMH). |
| Pharmacodynamics | Sulodexide is extensively absorbed owing to its low molecular weight compared to unfractionated heparin. It offers the potential advantages of a longer half-life and reduced global anticoagulation effects, properties which differ from other glycosaminoglycans. Sulodexide potentiates antithrombin III and heparin cofactor II due to the presence of both glycoaminoglycan fractions. It is capable of inhibiting both anti-IIa and anti-Xa. It promotes fibrinolytic activity by releasing tissue plasminogen activator and reduces plasminogen activator inhibitor. The drug also blocks platelet adhesion and platelet function induced by cathepsin G and thrombin. Research has also shown that Sulodexide had endothelial protective properties by inducing the overexpression of growth factors important for the protection of organs. It has anti-inflammatory properties via its effect on the release of inflammatory mediators from macrophages. This results in anti-proliferative effects such as the regulation of growth factors like VEGF and FGF. The intravenous administration has also been shown capable of releasing tissue factor pathway inhibitor from the endothelium, which also contributes to the anti-thrombotic effects of Sulodexide. Lastly, this drug is known for its ability to inhibit the secretion of MMPs, particularly MMP-9, from leukocytes in a dose dependent manner, resulting in the restoration of the balance with their tissue inhibitors. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Heparin cofactor 2 | Humans | agonist |
| Antithrombin-III | Humans | potentiator |
ADME / PK
| Absorption | Sulodexide can be administered via the oral route, IV and IM routes. After oral dosing, the absorption rate being equivalent, the bioavailability is 40-60%. either calculated from the fast-moving heparin fraction or from the dermatan fraction. Bioavailability following IM administration is approximately 90%. After a rapid absorption in the intestine, the dermatan and heparin components start to appear in the plasma. Sulodexide is degraded after ingestion and loses its sulfate groups and both sulfated and unsulfated groups circulate in the blood for up to 24hours. AUC=22.83+/-4.44mg.h/L. |
|---|---|
| Half-life | The elimination half-life was 11.7 +/- 2.0 h after intravenous administration, 18.7 +/- 4.1 h after 50 mg per os, and 25.8 +/- 1.9 h after 100 mg per os. |
| Metabolism | It is mainly metabolized in the liver. |
| Route of elimination | Sulodexide is eliminated via the renal, fecal and bile routes. The main clearance occurs renally and accounts for elimination of 55+2.9% of the drug over 96 hours. The fecal and bile routes remove the rest of the drug over 48 hours, which accounts for 23.5+/-2.5% for both routes. |
| Volume of distribution | Cmax=516+/-77.54ng/mL, Tmax=1.33+/-0.58h, Vd=71.24+/-14.06L (b phase). Sulodexide reaches high concentrations in the plasma and is widely distributed in the endothelial layer. Binding to endothelial cell receptors in arteries and veins contributes to its rapid distribution profile. |
| Clearance | 2.70+/-0.58L/h |
Formulation & handling
- Oral capsules contain a biotech-derived glycosaminoglycan mixture that may be sensitive to acidic and enzymatic degradation, warranting protective excipients for gastrointestinal transit.
- Parenteral solutions (IM/IV) require controls to prevent depolymerization and maintain polysaccharide chain integrity during manufacturing and storage.
- Avoid co-formulation with herbal or botanical components exhibiting anticoagulant/antiplatelet activity due to potential interaction risks.
Regulatory status
Safety
| Toxicity | Sulodexide seems to be well tolerated. Most adverse effects reported are related to the GI system and seem to be transient in nature. Among others adverse reactions are diarrhea, epigastralgia, dyspepsia, heartburn and dizziness. Allergic reactions, such as skin rash, have also been reported but are very rare. |
|---|
- GI-related reactions (diarrhea, dyspepsia, epigastralgia, heartburn) are the most frequently observed effects and are typically transient
- Occasional dizziness has been noted
- Hypersensitivity responses, including rare cutaneous reactions, have been reported
Sulodexide is a type of Antithrombotics
Antithrombotics, a subcategory of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in preventing and treating thrombotic disorders, which are characterized by the formation of blood clots within blood vessels. These medications are essential in reducing the risk of thrombosis, such as deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke, which can lead to severe health complications.
Antithrombotics exert their therapeutic effects through various mechanisms. One commonly used class of antithrombotics is anticoagulants, which inhibit the clotting process by interfering with the formation of blood clots. These drugs include heparin, warfarin, and direct oral anticoagulants (DOACs). They are administered to patients with conditions like atrial fibrillation, venous thromboembolism, or mechanical heart valves to prevent clot formation.
Another class of antithrombotics is antiplatelet agents, which prevent platelet aggregation, an essential step in blood clot formation. Aspirin, clopidogrel, and ticagrelor are well-known antiplatelet drugs used to prevent thrombosis in patients with coronary artery disease, ischemic stroke, or peripheral artery disease.
Antithrombotics are typically prescribed based on the individual patient's risk factors, medical history, and the specific thrombotic condition being treated. Dosage and administration instructions may vary depending on the drug's pharmacokinetic profile and desired therapeutic outcomes.
As with any medication, antithrombotics may have potential side effects, such as increased bleeding risk. Therefore, healthcare professionals carefully assess the patient's overall health status, including any underlying conditions, before prescribing these medications.
In conclusion, antithrombotics are a crucial subcategory of pharmaceutical APIs that play a vital role in preventing and treating thrombotic disorders. By inhibiting clot formation through various mechanisms, these medications significantly contribute to reducing the risk of serious complications associated with blood clots.
Sulodexide (Antithrombotics), classified under Anticoagulants
Anticoagulants are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used to prevent and treat blood clotting disorders. These medications play a crucial role in various medical conditions, including deep vein thrombosis (DVT), pulmonary embolism (PE), and atrial fibrillation (AF). Anticoagulants work by inhibiting the formation of blood clots or by preventing existing clots from getting larger.
There are different types of anticoagulants available, including direct thrombin inhibitors, vitamin K antagonists, and factor Xa inhibitors. Direct thrombin inhibitors, such as dabigatran, directly target the enzyme thrombin to hinder clot formation. Vitamin K antagonists, like warfarin, interfere with the production of clotting factors that rely on vitamin K. Factor Xa inhibitors, such as rivaroxaban and apixaban, inhibit the activity of factor Xa, a crucial component in the clotting cascade.
Anticoagulants are commonly prescribed to patients at risk of developing blood clots or those with existing clotting disorders. They are often used during surgeries, such as hip or knee replacements, to minimize the risk of post-operative clot formation. Patients with AF, a condition characterized by irregular heart rhythm, may also be prescribed anticoagulants to prevent stroke caused by blood clots.
While anticoagulants offer significant benefits in preventing and treating clot-related conditions, they also carry potential risks, including bleeding complications. Patients taking anticoagulants require careful monitoring to ensure the right dosage is administered, as excessive anticoagulation can lead to hemorrhage. Regular blood tests and close medical supervision are essential to manage the delicate balance between preventing clots and avoiding excessive bleeding.
In conclusion, anticoagulants are a crucial category of pharmaceutical APIs used to prevent and treat blood clotting disorders. They function by inhibiting clot formation or preventing existing clots from enlarging. While highly beneficial, their use requires careful monitoring to minimize the risk of bleeding complications.
Sulodexide API manufacturers & distributors
Compare qualified Sulodexide API suppliers worldwide. We currently have 4 companies offering Sulodexide 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 |
|---|---|---|---|---|---|
| Biofer | Producer | Italy | Italy | CoA, GMP | 7 products |
| Lab. Derivati Organici | Producer | Italy | Italy | CoA, GMP | 5 products |
| Opocrin S-C Plant | Producer | Italy | Italy | CoA, GMP | 7 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, USDMF | 757 products |
When sending a request, specify which Sulodexide 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.).
Use the list above to find high-quality Sulodexide API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
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