- Raw materials
- Other substances
- Susoctocog alfa
Susoctocog alfa API Manufacturers & Suppliers
0 verified results
When insight is your advantage
Full data, full access, full negotiation power
Total market transparency
|
Supplier trade data access
|
Buyer / supplier flow comparison
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 Susoctocog alfa 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 Susoctocog alfa 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!
Susoctocog alfa | CAS No: 1339940-90-7 | GMP-certified suppliers
A medication that treats bleeding episodes in adults with acquired hemophilia A by restoring functional coagulation factor VIII activity through recombinant porcine sequence protein.
Therapeutic categories
Blood and Blood Forming OrgansBlood Coagulation FactorsHemostatics
Generic name
Susoctocog alfa
Molecule type
biotech
CAS number
1339940-90-7
DrugBank ID
DB11606
Approval status
Approved drug, Investigational drug
ATC code
B02BD14
Primary indications
- Indicated for the treatment of bleeding episodes in adults with acquired hemophilia A
Product Snapshot
- Susoctocog alfa is available as an injectable lyophilized powder for intravenous administration
- It is used primarily for the treatment of bleeding episodes in adults with acquired hemophilia A
- The product is approved and marketed in the US, Canada, and the European Union
Clinical Overview
Susoctocog alfa is a recombinant, B-domain deleted, porcine sequence antihaemophilic factor VIII (FVIII) indicated for the treatment of bleeding episodes in adults with acquired haemophilia A (AHA). AHA is a rare autoimmune bleeding disorder characterized by the spontaneous development of inhibitory autoantibodies against human FVIII, resulting in impaired coagulation despite normal endogenous FVIII gene status. This leads to prolonged activated partial thromboplastin time (aPTT) and clinically significant bleeding.
Pharmacologically, susoctocog alfa functions as a replacement FVIII protein with a porcine sequence that exhibits reduced cross-reactivity with human anti-FVIII autoantibodies. This feature allows the product to temporarily replenish functional FVIII activity, restoring the coagulation cascade. Upon administration, susoctocog alfa normalizes aPTT values, reflecting the reinstatement of FVIII biological activity. Clinical evidence from a global, prospective Phase 2/3 open-label trial demonstrated all treated patients responded within 24 hours, achieving cessation or notable reduction of bleeding.
Mechanistically, FVIII circulates in plasma complexed non-covalently with von Willebrand factor (vWF), remaining inactive until coagulation activation triggers its release. Activated FVIII serves as a cofactor for factor IXa, enhancing the conversion of factor X to activated factor X, which then facilitates prothrombin cleavage into thrombin. Thrombin subsequently converts fibrinogen into fibrin, leading to clot formation. The porcine-derived sequence in susoctocog alfa confers less susceptibility to inhibition by human FVIII autoantibodies that target A2, A3, and C2 domains of endogenous FVIII.
Pharmacokinetic details specific to absorption, distribution, metabolism, and excretion are limited given its intravenous administration and role as a replacement protein. Safety considerations include monitoring for hypersensitivity reactions and immunogenicity, as with other recombinant clotting factors. The treatment allows therapeutic monitoring through FVIII activity assays, enabling clinical management of dose and efficacy.
Susoctocog alfa was approved by the US FDA in 2014 and is marketed under the brand name Obizur. It represents the first recombinant porcine FVIII product for acquired haemophilia A, offering a measurable and manageable hemostatic intervention in this rare patient population.
From an API sourcing and quality perspective, procurement should ensure recombinant origin with Porcine FVIII sequence integrity, appropriate glycosylation profile, and compliance with current Good Manufacturing Practices (cGMP). Analytical characterization to confirm B-domain deletion, purity, and consistent biological activity is critical to maintain clinical efficacy and safety.
Pharmacologically, susoctocog alfa functions as a replacement FVIII protein with a porcine sequence that exhibits reduced cross-reactivity with human anti-FVIII autoantibodies. This feature allows the product to temporarily replenish functional FVIII activity, restoring the coagulation cascade. Upon administration, susoctocog alfa normalizes aPTT values, reflecting the reinstatement of FVIII biological activity. Clinical evidence from a global, prospective Phase 2/3 open-label trial demonstrated all treated patients responded within 24 hours, achieving cessation or notable reduction of bleeding.
Mechanistically, FVIII circulates in plasma complexed non-covalently with von Willebrand factor (vWF), remaining inactive until coagulation activation triggers its release. Activated FVIII serves as a cofactor for factor IXa, enhancing the conversion of factor X to activated factor X, which then facilitates prothrombin cleavage into thrombin. Thrombin subsequently converts fibrinogen into fibrin, leading to clot formation. The porcine-derived sequence in susoctocog alfa confers less susceptibility to inhibition by human FVIII autoantibodies that target A2, A3, and C2 domains of endogenous FVIII.
Pharmacokinetic details specific to absorption, distribution, metabolism, and excretion are limited given its intravenous administration and role as a replacement protein. Safety considerations include monitoring for hypersensitivity reactions and immunogenicity, as with other recombinant clotting factors. The treatment allows therapeutic monitoring through FVIII activity assays, enabling clinical management of dose and efficacy.
Susoctocog alfa was approved by the US FDA in 2014 and is marketed under the brand name Obizur. It represents the first recombinant porcine FVIII product for acquired haemophilia A, offering a measurable and manageable hemostatic intervention in this rare patient population.
From an API sourcing and quality perspective, procurement should ensure recombinant origin with Porcine FVIII sequence integrity, appropriate glycosylation profile, and compliance with current Good Manufacturing Practices (cGMP). Analytical characterization to confirm B-domain deletion, purity, and consistent biological activity is critical to maintain clinical efficacy and safety.
Identification & chemistry
| Generic name | Susoctocog alfa |
|---|---|
| Molecule type | Biotech |
| CAS | 1339940-90-7 |
| UNII | 6892UQT2GK |
| DrugBank ID | DB11606 |
Pharmacology
| Summary | Susoctocog alfa is a recombinant Factor VIII product designed to restore hemostatic function in individuals with acquired hemophilia A by supplementing inhibited endogenous Factor VIII. It acts as a cofactor in the coagulation cascade, facilitating the activation of factor X and subsequent thrombin generation necessary for fibrin clot formation. The molecule has minimal cross-reactivity with circulating autoantibodies targeting native Factor VIII, enabling effective clotting activity despite the presence of inhibitory antibodies. |
|---|---|
| Mechanism of action | Factor VIII circulates in the plasma as a hemostatically active protein complex that consists of factor VIII and a large carrier protein von Willebrand factor via a non-covalent binding interaction. This protein complex remains inactive until the coagulation cascade is activated which in turn activates factor VIII to be released from factor VIII/von Willebrand factor complex. Activated factor VIII acts as a cofactor for factor IX-mediated conversion of factor X to activated factor X. Activated factor X is critical in converting prothrombin into thrombin and sequentially, thrombin converts fibrinogen to fibrin for the formation of a blood clot. Acquired haemophilia is a rare bleeding disorder where patients with normal Factor VIII genes spontaneously develop inhibitory autoantibodies directed against Factor VIII. These autoantibodies are IgG1 and IgG4 autoantibodies that bind to the A2, A3 and C2 domains of the FVIII molecules to inactivate them . The autoantibodies neutralize circulating human factor VIII and create a functional deficiency of this procoagulant protein. Susoctocog alfa serves to temporarily restore the inhibited endogenous Factor VIII for effective hemostasis. Circulating inhibitory autoantibodies have minimal or no cross-reactivity against susoctocog alfa. |
| Pharmacodynamics | Following susoctocog alfa administration, the activated partial thromboplastin time (aPTT) is expected to normalize indicating restored biological activity of factor VIII and normal clotting time . In a prospective, open-label clinical trail involving 28 subjects with acquired haemophilia A, all subjects had a positive response to treatment for the initial bleeding episodes at 24 hours after dosing where bleeding was either stopped or substantially reduced . |
Targets
| Target | Organism | Actions |
|---|---|---|
| von Willebrand factor | Humans | binding |
ADME / PK
| Absorption | The time to reach peak plasma concentrations (Tmax) is approximately 26 minutes or 0.42 hour following intravenous administration of 5000U susoctocog alfa in patients with acquired haemophilia in a non-bleeding state. |
|---|---|
| Half-life | The terminal half-life ranges from 2-17 hours in a non-bleeding state. Following intravenous dose of 5000U to patients with acquired haemophilia in a non-bleeding state, the terminal half life was approximately 3.8 hours . |
| Protein binding | Circulating susoctocog alfa binds to endogenous von Willebrand factor endogenously present in the circulation. |
| Volume of distribution | Following intravenous dose of 5000U to patients with acquired haemophilia in a non-bleeding state, the volume of distribution at steady state was 30.7 U/% . |
| Clearance | Following intravenous dose of 5000U to patients with acquired haemophilia in a non-bleeding state, the clearance rate was approximately 4.80 U/% * t . |
Formulation & handling
- Susoctocog alfa is a biotech-derived peptide formulated as a lyophilized powder for intravenous injection.
- Requires reconstitution prior to intravenous administration and is not intended for oral use.
- Handling requires maintenance of sterile conditions and protection from moisture to preserve stability.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient's key patents have expired in the US, Canada, and the EU, leading to an established market with multiple generic entries. As a result, the API is in a mature lifecycle phase across these regions. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Susoctocog alfa is supplied primarily through branded products available across the US, Canada, and EU markets, with a limited number of originator companies involved in its manufacture. The presence of branded products in major markets indicates established intellectual property rights; however, patent expirations could lead to the introduction of generic competition. The supply chain is thus characterized by a dominant role of originator manufacturers with potential for future generic entrants. |
|---|
Safety
| Toxicity | Long-term studies in animals to evaluate the carcinogenic potential, genotoxicity and effects on fertility have not been performed with susoctocog alfa. In repeated-dose studies, the incidence and severity of glomerulopathy observed in monkeys intravenously administered susoctocog alfa at doses of 75, 225 and 750 U/kg/day tended to increase over time . |
|---|
High Level Warnings:
- Long-term carcinogenicity, genotoxicity, and fertility studies have not been conducted
- Repeated intravenous administration in monkeys showed a dose- and time-dependent increase in glomerulopathy severity
- Monitor for potential renal toxicity during handling and formulation processes
Susoctocog alfa is a type of Other substances
The pharmaceutical industry encompasses a diverse range of active pharmaceutical ingredients (APIs) that are used in the production of various medications. One category of APIs is known as other substances. This category includes substances that do not fall under the conventional classifications such as antibiotics, analgesics, or antihypertensives.
Other substances in pharmaceutical APIs consist of a broad array of chemical compounds with unique properties and applications. These substances play a crucial role in the formulation and development of specialized medications, catering to specific therapeutic needs. The category encompasses various substances like excipients, solvents, stabilizers, and pH adjusters.
Excipients are inert substances that aid in the manufacturing process and enhance the stability, bioavailability, and patient acceptability of pharmaceutical formulations. Solvents are used to dissolve other ingredients and facilitate their incorporation into the final product. Stabilizers ensure the integrity and shelf life of medications by preventing degradation or chemical changes. pH adjusters help maintain the desired pH level of a formulation, which can influence the drug's efficacy and stability.
Pharmaceutical manufacturers carefully select and incorporate specific other substances into their formulations, adhering to regulatory guidelines and quality standards. These substances undergo rigorous testing and evaluation to ensure their safety, efficacy, and compatibility with the desired pharmaceutical product. By employing other substances in API formulations, pharmaceutical companies can optimize drug delivery, improve patient compliance, and enhance therapeutic outcomes.
In summary, the other substances category of pharmaceutical APIs comprises a diverse range of chemicals, including excipients, solvents, stabilizers, and pH adjusters. These substances contribute to the formulation, stability, and performance of medications, enabling pharmaceutical manufacturers to develop specialized products that meet specific therapeutic requirements.
