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- Idoxuridine
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Idoxuridine | CAS No: 54-42-2 | GMP-certified suppliers
A medication that treats herpes simplex virus–related keratoconjunctivitis and keratitis by inhibiting viral replication to reduce ocular infection and tissue damage.
Therapeutic categories
Primary indications
- For use in keratoconjunctivitis and keratitis caused by herpes simplex virus
Product Snapshot
- Idoxuridine is available in multiple ophthalmic and topical formulations including solutions, ointments, creams, and liquids
- It is primarily indicated for antiviral use in keratoconjunctivitis and keratitis caused by herpes simplex virus
- The product is approved or investigational in key markets such as the US and Canada
Clinical Overview
Pharmacodynamically, idoxuridine functions by incorporating into viral DNA in place of thymidine during replication. This substitution leads to the formation of defective viral DNA strands, producing pseudostructures that inhibit viral infectivity and cytotoxicity. The antiviral effect primarily targets cells during active viral DNA synthesis, which occurs in the early stages of herpes simplex lesion development and varies temporally across infected cells. Therefore, consistent application to maintain effective local drug concentration is critical for therapeutic success.
The mechanism of action involves inhibition of viral replication by preventing proper function of thymidylate phosphorylase and viral DNA polymerases. This interference halts viral genome replication, thereby reducing viral proliferation and limiting tissue damage. Idoxuridine does not directly destroy viral particles but disrupts their ability to reproduce and establish infection.
Key ADME parameters for idoxuridine are not extensively characterized in systemic use, given its topical ophthalmic administration. The drug demonstrates localized activity with minimal systemic absorption, which reduces systemic exposure and related toxicity. However, safety considerations include local toxicity such as ocular irritation and epithelial toxicity; caution is required to avoid prolonged use which may damage corneal tissues.
Idoxuridine is approved for clinical use in various countries and is often formulated for ocular application as topical solutions. It is classified within antiviral agents and nucleoside analogs recognized for nucleic acid synthesis inhibition.
For API sourcing and quality assurance, strict adherence to pharmacopeial purity standards is essential to ensure the absence of contaminants that could compromise formulation stability or clinical safety. Manufacturing should conform to Good Manufacturing Practices with validated analytical methods to monitor idoxuridine content, impurities, and batch consistency, given its clinical use in sensitive ocular applications.
Identification & chemistry
| Generic name | Idoxuridine |
|---|---|
| Molecule type | Small molecule |
| CAS | 54-42-2 |
| UNII | LGP81V5245 |
| DrugBank ID | DB00249 |
Pharmacology
| Summary | Idoxuridine is an antiviral agent targeting herpes simplex virus by incorporating into viral DNA in place of thymidine, disrupting viral DNA synthesis. This substitution inhibits thymidylate phosphorylase and viral DNA polymerase activity, leading to the production of defective viral DNA and preventing viral replication and tissue infection. Its pharmacodynamic effect is specific to cells undergoing active viral DNA synthesis. |
|---|---|
| Mechanism of action | Idoxuridine acts as an antiviral agent by inhibiting viral replication by substituting itself for thymidine in viral DNA. This in turn inhibits thymidylate phosphorylase and viral DNA polymerases from properly functioning. The effect of Idoxuridine results in the inability of the virus to reproduce or to infect/destroy tissue. |
| Pharmacodynamics | In chemical structure idoxuridine closely approximates the configuration of thymidine, one of the four building blocks of DNA (the genetic material of the Herpes virus). As a result, idoxuridine is able to replace thymidine in the enzymatic step of viral replication or "growth". The consequent production of faulty DNA results in a pseudostructure which cannot infect or destroy tissue. In short, by pre-empting a vital building block in the genetic material of the Herpes simplex virus, Herplex-D topical solution destroys the infective and destructive capacity of the viral material. The virus infected cell may only be attacked during the period of active synthesis of DNA. This occurs early in the development of the Herpes simplex lesion, but at different times in different cells. Therefore, ideally, the affected area should remain saturated with the antiviral agent. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA | Humans | other |
| Thymidine kinase | HHV-1 | unknown |
ADME / PK
| Absorption | Systemic absorption is unlikely following ocular administration even when nasolacrimal secretions are swallowed, since vidarabine is rapidly deaminated in the gastrointestinal tract. |
|---|---|
| Metabolism | Idoxuridine is rapidly inactivated by deaminases or nucleotidases. |
Formulation & handling
- Idoxuridine is a small molecule with ophthalmic and topical routes of administration, not intended for oral or injectable use.
- It is water-soluble with a low LogP, indicating suitability for aqueous formulations such as solutions and drops.
- As a nucleoside analog, it requires protection from light and moisture to maintain stability during storage and handling.
Regulatory status
| Lifecycle | The API's key patents have expired, allowing for generic entry in the US and Canada. As a result, the product markets in these regions are in a mature phase characterized by increased generic competition. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for Idoxuridine includes multiple originator companies with notable roles in production, including Glaxosmithkline, Alcon Laboratories Inc., and Allergan Pharmaceutical. The branded products have a presence primarily in the US and Canadian markets. Given the availability of brands like Sandoz Idoxuridine, which is known for generic formulations, patent expiry has likely allowed for existing generic competition in these regions. |
|---|
Safety
| Toxicity | Hypersensitivity or increased sensitivity of eyes to light. LD<sub>50</sub>=3080 mg/kg (orally in mice). |
|---|
- May cause hypersensitivity reactions, including photosensitivity of the eyes
- Oral LD50 in mice is 3080 mg/kg, indicating moderate acute toxicity
- Handle with appropriate protective equipment to minimize ocular exposure
Idoxuridine 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.
Idoxuridine (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.
