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Cidofovir | CAS No: 113852-37-2 | GMP-certified suppliers
A medication that supports management of cytomegalovirus retinitis in adults with AIDS, offering targeted antiviral control for specialized clinical and procurement needs.
Therapeutic categories
Primary indications
- For the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)
Product Snapshot
- Cidofovir is an intravenous injectable small‑molecule antiviral available as solution and concentrate formulations
- It is used for CMV retinitis in immunocompromised patients, including those with AIDS
- It is approved in the US, Canada, and the EU
Clinical Overview
Cidofovir exerts antiviral activity through selective inhibition of viral DNA synthesis. After cellular uptake, it is converted to cidofovir diphosphate, which demonstrates high affinity for CMV DNA polymerase. The metabolite inhibits viral polymerases at concentrations markedly lower than those required to inhibit human DNA polymerase isoforms. Incorporation of cidofovir into viral DNA slows chain elongation and reduces productive replication. This specificity underlies its utility in controlling progressive CMV retinitis.
Pharmacokinetic data show that cidofovir is eliminated predominantly by the kidney, with active tubular secretion via OAT1 transport pathways. The long intracellular half-life of the diphosphate metabolite supports intermittent dosing schedules. Renal clearance is the principal determinant of systemic exposure.
Safety considerations focus on nephrotoxicity, which is dose limiting and related to proximal tubular injury. Concomitant probenecid and hydration strategies have historically been used to mitigate renal uptake. Additional concerns include ocular events related to the underlying disease process and potential systemic toxicities common to nucleotide analogues. Cidofovir is contraindicated in patients with significant baseline renal impairment or those receiving other nephrotoxic agents.
Although branded formulations are discontinued, cidofovir remains relevant for reference purposes and limited specialized use contexts. For API procurement, sourcing should prioritize verification of identity, impurity profile, and stability consistent with pharmacopeial and regulatory expectations, with particular attention to controlling nephrotoxic impurities and ensuring robust documentation to support quality and safety assessments.
Identification & chemistry
| Generic name | Cidofovir |
|---|---|
| Molecule type | Small molecule |
| CAS | 113852-37-2 |
| UNII | 768M1V522C |
| DrugBank ID | DB00369 |
Pharmacology
| Summary | Cidofovir is a nucleotide analogue antiviral that suppresses cytomegalovirus replication by selectively inhibiting the viral DNA polymerase. Its active metabolite, cidofovir diphosphate, interferes with viral DNA chain elongation at concentrations far below those affecting human DNA polymerases. This targeted inhibition reduces viral DNA synthesis in CMV‑infected cells. |
|---|---|
| Mechanism of action | Cidofovir acts through the selective inhibition of viral DNA polymerase.Biochemical data support selective inhibition of CMV DNA polymerase by cidofovir diphosphate, the active intracellular metabolite of cidofovir. Cidofovir diphosphate inhibits herpesvirus polymerases at concentrations that are 8- to 600-fold lower than those needed to inhibit human cellular DNA polymerase alpha, beta, and gamma(1,2,3). Incorporation of cidofovir into the growing viral DNA chain results in reductions in the rate of viral DNA synthesis. |
| Pharmacodynamics | Cidofovir is a new anti-viral drug. It is classified as a nucleotide analogue and is active against herpes cytomegalovirus (CMV) retinitis infection. Most adults are infected with CMV. Cidofovir suppresses cytomegalovirus (CMV) replication by selective inhibition of viral DNA synthesis. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA polymerase catalytic subunit | HHV-5 | inhibitor |
ADME / PK
| Absorption | 100% |
|---|---|
| Half-life | 2.4 to 3.2 hours |
| Protein binding | 6% |
| Volume of distribution | * 537 ± 126 mL/kg [VISTIDE ADMINISTERED WITHOUT PROBENECID] * 410 ± 102 mL/kg [VISTIDE ADMINISTERED WITH PROBENECID] |
| Clearance | * 179 +/- 23.1 mL/min/1.73 m2 [WITHOUT PROBENECID] * 148 +/- 38.8 mL/min/1.73 m2 [WITH PROBENECID] |
Formulation & handling
- Formulated exclusively for intravenous use, leveraging its high aqueous solubility and small‑molecule profile for simple aqueous solutions or concentrates.
- Low logP and high polarity favor stable aqueous formulations but limit suitability for oral dosage forms.
- Handling typically focuses on maintaining solution stability and preventing precipitation during dilution or storage.
Regulatory status
| Lifecycle | The API’s primary patent protection lapsed first in the United States in 2010 and later in Canada in 2016, indicating long-standing generic availability in both markets. With presence in the US, Canada, and the EU, the product is positioned in a mature market phase with no remaining core patent exclusivities. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Cidofovir is supplied primarily by a single originator manufacturer, with several secondary packagers supporting distribution. Branded and equivalent products are available across the US, Canada, and the EU, indicating an established global presence. With key patents in these markets having expired, generic competition is already possible and may expand where regulatory pathways allow. |
|---|
Safety
| Toxicity | Kidney damage, fall in the number of white blood cells, decreased platelets |
|---|
- Associated with nephrotoxic potential
- Handling protocols typically account for risks of renal accumulation and related structural injury
- Can induce marked hematologic suppression, including reductions in leukocyte and platelet counts, requiring controls that limit exposure and support appropriate in‑process monitoring
Cidofovir 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.
Cidofovir (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.
Cidofovir API manufacturers & distributors
Compare qualified Cidofovir API suppliers worldwide. We currently have 2 companies offering Cidofovir 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 |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
When sending a request, specify which Cidofovir 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 Cidofovir 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.
Frequently asked questions about Cidofovir API
Sourcing
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Technical
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Regulatory
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