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Foscarnet | CAS No: 4428-95-9 | GMP-certified suppliers
A medication that treats CMV retinitis in AIDS patients and acyclovir-resistant mucocutaneous HSV infections in immunocompromised individuals with direct antiviral activity.
Therapeutic categories
Primary indications
- For the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) and for treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients
Product Snapshot
- Foscarnet is an intravenous injectable small molecule antiviral agent
- It is primarily used for treating CMV retinitis in AIDS patients and acyclovir-resistant mucocutaneous HSV infections in immunocompromised individuals
- The product is approved for use in the US and Canadian markets
Clinical Overview
Pharmacodynamically, foscarnet inhibits the replication of herpes viruses including CMV, HSV-1, and HSV-2. Unlike nucleoside analogues, it does not require intracellular phosphorylation by viral thymidine kinase or other kinases for activation. This property enables foscarnet to retain activity against viral strains harboring mutations in thymidine kinase (HSV) or UL97 kinase (CMV) that confer resistance to acyclovir and ganciclovir. However, resistance may still emerge from mutations in viral DNA polymerase that diminish foscarnet binding.
Mechanistically, foscarnet selectively inhibits viral DNA polymerases by binding directly to the pyrophosphate binding site, thereby preventing nucleotide incorporation during viral DNA elongation. This inhibition occurs at concentrations that minimally affect host cellular DNA polymerases, contributing to its antiviral specificity.
Absorption, distribution, metabolism, and excretion (ADME) parameters indicate that foscarnet is administered intravenously due to poor oral bioavailability. It is primarily cleared unchanged by renal excretion, necessitating dose adjustments in patients with renal impairment. The drug displays potential nephrotoxicity, and close monitoring of renal function is recommended. Electrolyte imbalances and QTc interval prolongation have also been reported during therapy.
Foscarnet is approved for clinical use and is categorized as a nucleic acid synthesis inhibitor, enzyme inhibitor, and direct-acting antiviral with noted chelating properties. It may be included in combination antiviral regimens, especially where resistance to standard nucleoside analogues exists.
From an API procurement perspective, sourcing foscarnet requires attention to stringent quality control, including purity assessment and compliance with pharmacopeial standards due to its critical role in treating immunocompromised patients. Stability under appropriate storage conditions and avoidance of contamination with heavy metals or related impurities are important considerations in ensuring consistent clinical efficacy and safety.
Identification & chemistry
| Generic name | Foscarnet |
|---|---|
| Molecule type | Small molecule |
| CAS | 4428-95-9 |
| UNII | 364P9RVW4X |
| DrugBank ID | DB00529 |
Pharmacology
| Summary | Foscarnet is an antiviral agent that selectively inhibits viral DNA polymerases by binding to the pyrophosphate site, thereby preventing viral DNA replication. It is active against herpes viruses, including CMV and acyclovir-resistant HSV strains, without requiring enzymatic activation. Its mechanism targets virus-specific DNA polymerases while sparing host cellular polymerases. |
|---|---|
| Mechanism of action | Foscarnet exerts its antiviral activity by a selective inhibition at the pyrophosphate binding site on virus-specific DNA polymerases at concentrations that do not affect cellular DNA polymerases. |
| Pharmacodynamics | Foscarnet is an organic analogue of inorganic pyrophosphate that inhibits replication of herpes viruses <i>in vitro</i> including cytomegalovirus (CMV) and herpes simplex virus types 1 and 2 (HSV-1 and HSV-2). Foscarnet does not require activation (phosphorylation) by thymidine kinase or other kinases and therefore is active in vitro against HSV TK deficient mutants and CMV UL97 mutants. Thus, HSV strains resistant to acyclovir or CMV strains resistant to ganciclovir may be sensitive to foscarnet. However, acyclovir or ganciclovir resistant mutants with alterations in the viral DNA polymerase may be resistant to foscarnet and may not respond to therapy with foscarnet. The combination of foscarnet and ganciclovir has been shown to have enhanced activity in vitro. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA polymerase catalytic subunit | HHV-1 | inhibitor |
| DNA polymerase catalytic subunit | HHV-5 | inhibitor |
ADME / PK
| Absorption | Poorly absorbed after oral administration (bioavailability from 12 to 22%). |
|---|---|
| Half-life | 3.3-6.8 hours |
| Protein binding | 14-17% |
| Metabolism | Not metabolized. |
| Clearance | * 2.13 +/- 0.71 mL/min/kg [patients had normal renal function (CrCl > 80 mL/min] * 68 +/- 8 mL/min/kg [CrCl was 50-80 mL/min] * 34 +/- 9 mL/min/kg [CrCl was 25-49 mL/min] * 20 +/- 4 mL/min/kg [CrCl was 10 - 24 mL/min] |
Formulation & handling
- Foscarnet is a small molecule indicated for intravenous injection formulations due to its aqueous solubility and therapeutic use.
- As an organic phosphonic acid derivative with high water solubility and negative LogP, it requires aqueous-based formulation approaches.
- Stable handling conditions are essential to maintain solution integrity for intravenous administration, with attention to sterile processing.
Regulatory status
| Lifecycle | The API is approaching patent expiry in the US and Canada, leading to increased availability of generic alternatives and a transition towards a more mature market phase characterized by competitive pricing and broader access. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Foscarnet involves multiple originator companies, including Hospira Inc. and Clinigen Healthcare Ltd, with packaging handled by firms such as AstraZeneca Inc. The product is primarily marketed in North American regions, specifically the US and Canada. The presence of multiple branded formulations and manufacturers, alongside the availability of generics, indicates existing generic competition following patent expirations. |
|---|
Safety
| Toxicity | Oral, rat LD<sub>50</sub>: >2,000 mg/kg. Signs of overdose include renal impairment. |
|---|
- Oral LD50 (rat) › 2,000 mg/kg indicates low acute toxicity
- Overdose may result in renal impairment
- Monitor renal function during handling
Foscarnet is a type of Antivirals
Antivirals are a crucial subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a pivotal role in combating viral infections. These specialized compounds are designed to inhibit the growth and replication of viruses within the human body.
Antivirals target various stages of the viral life cycle, including viral attachment, entry, and replication. They can interfere with viral enzymes, block viral receptors, or disrupt viral protein synthesis. By doing so, antivirals effectively suppress the viral infection, reduce symptoms, and improve patient outcomes.
The development of antiviral APIs requires extensive research and scientific expertise. Pharmaceutical companies employ cutting-edge technologies to identify potential antiviral compounds, screen their efficacy, and optimize their therapeutic properties. The most promising candidates undergo rigorous testing in preclinical and clinical trials to ensure their safety and effectiveness.
Antivirals have proven to be indispensable in the management of various viral infections, such as influenza, HIV, hepatitis B and C, herpes, and respiratory syncytial virus (RSV). They not only provide symptomatic relief but also prevent viral transmission and reduce the risk of complications.
With the ongoing global concern over emerging viral diseases and the impact of pandemics, the demand for effective antiviral therapies continues to rise. Pharmaceutical companies and researchers are actively exploring new avenues, such as broad-spectrum antivirals and novel drug delivery systems, to enhance the antiviral arsenal.
In conclusion, antiviral APIs are vital components of the pharmaceutical industry, offering hope in the fight against viral infections. Through continuous innovation and research, these substances contribute to improving public health by mitigating the impact of viral diseases.
Foscarnet (Antivirals), classified under Anti-infective Agents
Anti-infective agents are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of various infectious diseases. These agents play a crucial role in combating bacterial, viral, fungal, and parasitic infections. The demand for effective anti-infective APIs has grown significantly due to the increasing prevalence of drug-resistant microorganisms.
Anti-infective APIs encompass a wide range of substances, including antibiotics, antivirals, antifungals, and antiparasitics. Antibiotics are particularly important in fighting bacterial infections and are further categorized into different classes based on their mode of action and target bacteria. Antivirals are designed to inhibit viral replication and are essential in the treatment of viral infections such as influenza and HIV. Antifungals combat fungal infections, while antiparasitics are used to eliminate parasites that cause diseases like malaria and helminthiasis.
The development and production of high-quality anti-infective APIs require stringent manufacturing processes and adherence to regulatory standards. Pharmaceutical companies invest heavily in research and development to discover new and more effective anti-infective agents. Additionally, ensuring the safety, efficacy, and stability of these APIs is of utmost importance.
The global market for anti-infective APIs is driven by factors such as the rising incidence of infectious diseases, the emergence of new and drug-resistant pathogens, and the growing demand for improved healthcare infrastructure. Continuous advancements in pharmaceutical technology and the development of innovative drug delivery systems further contribute to the expansion of this market.
In conclusion, anti-infective agents are a critical category of pharmaceutical APIs that play a pivotal role in treating infectious diseases. Their effectiveness in combating various types of infections makes them essential components in the arsenal of modern medicine.
Foscarnet API manufacturers & distributors
Compare qualified Foscarnet API suppliers worldwide. We currently have 2 companies offering Foscarnet 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 |
|---|---|---|---|---|---|
| Emcure Pharma | Producer | India | India | CoA, USDMF | 80 products |
| Lianyungang Runzhong | Producer | China | China | CEP, CoA, GMP, USDMF, WC | 6 products |
When sending a request, specify which Foscarnet 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 Foscarnet 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.
